Apogee Therapeutics is a biopharmaceutical company dedicated to developing innovative therapies for a wide range of diseases. With a focus on cutting-edge research and a commitment to improving patient outcomes, Apogee Therapeutics is at the forefront of the healthcare industry.

Director, Computer System Validation - Quality Assurance (CSV QA)

Associate Director, GxP R&D Systems

Associate Director, Biomarker Discovery and Development

Senior Director, Late-Stage Readiness Lead

Clinical Contracts Manager - Legal

Director, Corporate Counsel, Privacy & Compliance

Scientist, Formulations and Drug Product Development

Principal Scientist - Analytical Development (Bioassay)

Welcome Ambassador

Sunland Park Assistant Manager

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee’s pipeline. This individual will be an important leader driving the TechOps and CMC Regulatory strategy, reporting to the VP of Analytical Development and Quality Control. Key Responsibilities&nbsp; Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing; in-process/release/stability testing; specification justification and maintenance; shelf-life management; and critical documentation Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results Ideal Candidate&nbsp; PhD in relevant discipline (e.g., analytical biochemistry or relevant field) 15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly Experience with regulatory filing preparation and messaging across global jurisdictions Deep knowledge and understanding of relevant global regulatory guidance and requirements Ability to keep pace with a fast-moving organization Availability to participate in calls across multiple international time zones Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 30% The anticipated salary range for candidates for this role will be $245,000-$260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Director, Quality Control Analytical Sciences

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced biotech industry Director, Clinical Development to support the scientific planning and execution of one or more clinical trials focused on atopic dermatitis. This role involves working closely with cross-functional teams to design, implement, oversee and analyze clinical studies to advance the development of innovative dermatology therapies. In this role you will contribute scientific expertise and strategic insights to ensure the successful progression of clinical programs. Key Responsibilities&nbsp; Collaborate with cross-functional teams to develop clinical documents for dermatology-related trials with scientific rigor, such as protocol, investigator brochure, clinical study report, scientific publications/presentations, etc. Contribute scientific input and implementation into the study design and execution, including but not limited to selection of appropriate endpoints, patient populations, and study methodologies; site selection; investigator meetings; and study initiation activities Monitor the clinical trials for both quality and safety, ensuring adherence to protocols, timelines, and quality standards Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making Collaborate with data management and biostatistics to develop and validate data collection tools and ensure accurate and timely data capture Foster relationships with clinical investigators to gather insights, address scientific questions, and promote collaboration Stay current with scientific literature and advancements in dermatology/immunology and related therapeutic areas Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals Ideal Candidate&nbsp; Advanced degree in life science field (e.g., PhD, PharmD, or DVM) Must have 5 +years of experience in research, with 2+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry preferred; focus on dermatology, particularly experience in atopic dermatitis desired Strong understanding of clinical trial design, execution, and data analysis Analytical mindset and ability to interpret complex scientific data Ability to manage multiple competing priorities with good planning, time management and prioritization skills Strong communication, technical writing, and presentation skills, with the ability to effectively convey scientific concepts to diverse audiences Proven ability to work in a cross-functional team environment Solid knowledge of Good Clinical Practice (GCP) and ethical guidelines governing clinical research Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires approximately 35% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $230,000-$260,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Clinical Development – Dermatology/Immunology

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associator Director, Monitoring Oversight Management, to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials.&nbsp; This role will also support contract Oversight CRAs globally.&nbsp; In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity. &nbsp;Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. &nbsp;This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies. Key Responsibilities In-house responsibilities The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements Responsible for hiring in-house Oversight CRAs Assist with creation, review and revision of departmental SOPs and policies, as applicable Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency Assist with creation and delivery of department initiatives, improvement plans and/or training Create SOPs and process to support the responsibilities of the monitoring excellence organization Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained Contribute to development and implementation of risk-based monitoring strategies Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas Facilitate resolution of region specific and site management related challenges Communication and issue resolution with clinical vendors, as needed Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools) Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained Periodic review of monitoring visit reports and metrics, as applicable Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities Support and liaise with clinical site personnel, as needed Review and approve time sheets and expense reports Field management responsibilities Conduct periodic quality visits for Senior Oversight CRAs, as needed Ensure all site oversight visits are completed within the expected timelines globally Oversee all timelines and KPIs for the oversight monitoring team globally Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites Ideal Candidate Bachelor's degree in a scientific or healthcare-related field Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry Minimum 5 years of experience leading a team of CRAs Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred Experience working in Phase I – III clinical trials Recent experience working on trials utilizing risk-based monitoring models Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems Strong understanding of clinical trial processes and study conduct Excellent organizational and time management skills Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight Experience working in a fast-paced and dynamic environment Certification as a Clinical Research Associate (CCRA) or equivalent preferred Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year, travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office This position may also require US and international travel to clinical sites and/or medical conferences The anticipated salary range for candidates for this role will be $180,000-$205,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp;&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Monitoring Oversight Management

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, Clinical Programming, to join the Data Management team. In this position you will be responsible for both managing and analyzing clinical trial data using programming languages like SAS, R, and Python to ensure data integrity, generate tables and figures, and support regulatory submissions.&nbsp;Key responsibilities include data cleaning, developing statistical programs, creating reports, validating outputs, and collaborating with statisticians and data managers to assess drug safety and efficacy.&nbsp;Ensure compliance with&nbsp;CDISC standards&nbsp;and regulatory guidelines to support decision-making. &nbsp;Key Responsibilities&nbsp; Clean, validate, and transform raw clinical trial data from various sources into standardized formats, such as CDISC SDTM Participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports Develop and execute SAS programs (or other languages like R/Python) to create datasets, tables, listings, and figures (TLFs) as specified in the&nbsp;Statistical Analysis Plan&nbsp;(SAP) Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed Work closely with CROs to prepare and ensure proper development and execution of data management activities Review protocols to ensure database feasibility Perform statistical analyses support for the efficacy and safety evaluation of treatments Perform quality control (QC) checks on vendor programming work, including SAS code and generated outputs, to ensure accuracy and adherence to standards Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion, and to design analyses, interpret results, and solve programming challenges Ensure all programming and data activities comply with Good Clinical Practice (GCP) and regulatory agency guidelines Maintain comprehensive documentation of programming work for audit trails and regulatory submissions Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs Build and mentor a team of programmers(s) to effectively support clinical trials and pipeline Ideal Candidate&nbsp; Bachelor’s Degree in a position relevant field, such as statistics, computer science, or scientific discipline preferred Minimum of 8 to 10 years of clinical programming in pharma/biotech industry Direct people management experience in a remote setting is a plus Late-stage regulatory submission experience (NDA, sNDA and BLAs) highly preferred Proficiency in statistical programming languages such as SAS Technology proficiency includes Data Management Systems Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality Familiarity with clinical data standards like CDISC SDTM and CDISC Extensive experience managing CROs and other data vendors Strong analytical and problem-solving skills to identify and resolve data issues Knowledge of Good Clinical Practice EDC and eCOA experience (Medidata, Veeva, etc.) Understanding of clinical trial design, protocols, and regulatory requirements Ability to keep pace in a fast-moving organization and navigate ambiguity Ability to communicate effectively with both technical and non-technical team members Meticulous attention to detail is crucial for data accuracy and consistency Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel 10-15% or as needed by the business The anticipated salary range for candidates for this role will be $185,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Programming

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary This role will support the Payroll Manager and Director, Payroll &amp; Equity Administration, in end-to-end payroll processing, including regular and off-cycle payrolls, resolving tax notices, and processing new hires, terminations, and employee data changes. The Payroll Specialist will ensure payroll accuracy, compliance, and support audits, reconciliations, while delivering high-quality and timely customer service to employees. Key Responsibilities Support the payroll team with end-to-end payroll processing, including regular and off-cycle payrolls in accordance with SOX internal controls and company policies Work closely with the payroll and people team to ensure accurate and timely processing of new hires, terminations, and employee data changes Respond to employee payroll inquiries and provide timely issue resolution and service Perform payroll reconciliations and ad hoc reporting to support audits, management requests, and payroll-related projects Assist with year-end and month-end payroll activities, including W-2 preparation and reconciliation Maintain payroll documentation and ensure confidentiality and data integrity Assist with and reconcile equity compensation transactions into payroll and perform YTD wage reconciliations Help resolve payroll tax notices by researching discrepancies and coordinating any amendments and responses Other ad-hoc duties as assigned Ideal Candidate Bachelor’s degree in finance, accounting or related field preferred CPP certification is a plus 3+ years of payroll processing experience; public company and/or biotechnology or life sciences industry experience preferred ADP, Workday, or similar payroll system experience preferred Excellent verbal and written communication skills Hands-on experience processing multi-state payroll Strong working knowledge of federal, state, and local payroll tax regulations Experience researching and resolving payroll tax notices Strong Excel skills, including data review and basic reconciliations High attention to detail with a strong focus on accuracy Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $95,000-$110,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Payroll Analyst

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.&nbsp; Key Responsibilities Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project&nbsp;objectives&nbsp;are met&nbsp; Initiate and build strong relationships with key opinion leaders and clinical site staff Partner with the CRO&nbsp;to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget&nbsp;for assigned regions Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data Proactively&nbsp;identify&nbsp;and manage study related risks Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs),&nbsp;and&nbsp;consents Review and manage study related plans and processes including Investigator agreements (CTA),&nbsp;site budget review,&nbsp;CRFs, CRF guidelines,&nbsp;Statistical&nbsp;Analysis Plans, Pharmacokinetic&nbsp;Analysis&nbsp;Plans,&nbsp;Monitoring plan,&nbsp;Data&nbsp;Management&nbsp;Plan, and&nbsp;Safety&nbsp;Monitoring&nbsp;Plan Collaborate with Regulatory/CRO team members to&nbsp;assist&nbsp;with completion/review of regulatory submissions Review CRO and vendor contracts/work orders and specifications to align with study objectives Review specifications for systems build and&nbsp;participate&nbsp;in User Acceptance Testing (UAT) (eg, IRT,&nbsp;eCOA, EDC) Participate in data cleaning and manage database lock&nbsp;activities&nbsp;with cross functional team Oversee review and approve essential document packages to enable&nbsp;timely&nbsp;site activations Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Participate in&nbsp;TMF&nbsp;review&nbsp;and ensure&nbsp;quality and&nbsp;completeness&nbsp;throughout&nbsp;end of the study Ensure the study is always “inspection ready”&nbsp; Oversee and coach the functional activities of Clinical Trial Associates&nbsp;allocated&nbsp;to the project&nbsp; Ideal Candidate Bachelor’s degree in life science or equivalent Minimum of 5 years of clinical trial management experience in conducting international clinical trials in&nbsp;a Sponsor Pharma/Biotech organization.&nbsp;&nbsp;Biotech experience strongly preferred.&nbsp;&nbsp; Prior phase II and III experience&nbsp;required A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Proven&nbsp;proficiency&nbsp;in overseeing complex studies being managed in house and by a CRO Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively Experience selecting and managing clinical vendors to support study activities Enjoys building relationships with KOLs and site personnel Demonstrated ability to build and deliver on patient enrolment strategies Demonstrates innovation,&nbsp;possesses&nbsp;drive, energy, and enthusiasm to deliver the program objectives Demonstrated ability to review and&nbsp;comprehend&nbsp;complex scientific concepts and clinical data Strong planning, time management,&nbsp;and coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Excellent written and oral communication skills Position requires up&nbsp;to 35%travel, including mandatory&nbsp;in-person&nbsp;attendance at Apogee All Hands meetings typically held twice per year.&nbsp;Travel is also&nbsp;required&nbsp;to attend key Phase 3 meetings,&nbsp;typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.&nbsp; The anticipated salary range for candidates for this role will be $145,000- $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Clinical Trial Manager

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs. Key Responsibilities Act as a central contact for the&nbsp;cross-functional&nbsp;study&nbsp;team for designated project communications, correspondence, and associated documentation Maintain&nbsp;and perform QC reviews on&nbsp;study specific electronic Trial Master Files&nbsp;to ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices Track and report study metrics; inclusive of start-up, data management, and contracting as needed Participate in&nbsp;GxP&nbsp;audits and related clinical compliance activities Prepare and track study documents (e.g., contracts, budgets, IRB documentation) Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.)&nbsp;and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards Administer user access and change control within Apogee’s electronic systems Assist&nbsp;in User Acceptance Testing for all EDC needs&nbsp;in regard to&nbsp;Data Management and all Clinical Systems Assist&nbsp;with vendor management and associated&nbsp;logistics, as assigned Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations Collaborate with Clinical Project Manager, Clinical Supply&nbsp;Unit&nbsp;and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs,&nbsp;monitors&nbsp;and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to&nbsp;assist&nbsp;with clinical monitoring duties upon completion of required training.&nbsp;&nbsp; Organize and/or&nbsp;participate&nbsp;in meetings with CROs. Ensure&nbsp;appropriate meeting&nbsp;minutes are prepared and filed in TMF Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information Assist&nbsp;in creating and implementing departmental procedures&nbsp;Assist with information gathering, literature searches, and creation of presentations, as needed Responsible for managing team training assignments and oversight/ownership of due dates to support compliance &nbsp; Ideal Candidate BS/BA in Life Sciences or equivalent 4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&amp;D environment Extensive experience&nbsp;with&nbsp;TMF, including set-up, maintenance, QC/ QR&nbsp;and query management. Familiar with DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated&nbsp;proficiency&nbsp;in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while&nbsp;maintaining&nbsp;high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, SmartSheet, and ISI Toolbox Strong critical thinking, organizational and time-management skills Successfully&nbsp;exhibit&nbsp;Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position&nbsp;requires&nbsp;up to 15-20% travel,including mandatory&nbsp;in-person&nbsp;attendance at Apogee All Hands meetings typically held twice per year.&nbsp;Travel is also&nbsp;required&nbsp;to attend key Phase 3 meetings,&nbsp;typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.&nbsp; The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year.The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Clinical Trial Associate

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives. Key Responsibilities Develop and implement global CMC and device regulatory strategies for assigned program(s) Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions) Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans Identify regulatory risks associated with product development and propose mitigation strategies Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth Ideal Candidate Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred Proven track record of leading cross-functional submission teams and successful regulatory submissions Strong knowledge of global regulatory requirements (FDA, EMA, ICH) Excellent communication, leadership, and project management skills Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless The anticipated salary range for candidates for this role will be $220,000-$240,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, CMC and Device Regulatory Affairs

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity. &nbsp;Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites. The Clinical Monitoring Manager collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives. Key Responsibilities In-house responsibilities The Clinical Monitoring Manager is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements May be responsible for the hiring of in-house CRAs Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms) Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plans, site visit report templates, monitoring tools) Support the training and development of in-house CRAs and ensuring study training compliance is maintained Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed Responsible for oversight of CRA review of clinical data (e.g., electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations Support and liaise with clinical site personnel, as needed Review and approve time sheets and expense reports Assist with review and revision of departmental SOPs and policies Assist with creation and delivery of new department initiatives, improvement plans or training May assist with the identification and selection of appropriate clinical trial sites and investigators Field monitoring responsibilities Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines Review and ensure data integrity, accuracy, and completeness at the clinical study sites Escalate site related issues to the study team Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed Ideal Candidate Bachelor's degree in a scientific or healthcare-related field Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry Minimum 2 years of experience leading a team of CRAs Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus Certification as a Clinical Research Associate (CCRA) or equivalent preferred Recent experience working on trials utilizing risk-based monitoring models Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems Strong understanding of clinical trial processes and study conduct Excellent organizational and time management skills Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight Experience working in a fast-paced and dynamic environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $150,000 - $170,000. per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Clinical Monitoring Manager

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary The Clinical Operations Vendor Manager is a member of the Clinical Trial Excellence Vendor Strategy &amp; Management team and is responsible for facilitating the identification, selection, and management of clinical study vendors and providing portfolio level issue trending, escalation and management. This role will act as a liaison between Apogee and external vendors while working to find cost savings and operational efficiencies and will help support and implement the strategic vision outlined by the Vendor Strategy &amp; Management Lead. He/she will work with cross-functional members of the Apogee organization (Clinical, Finance, and Legal) to assess the best fit for Apogee’s growing Phase 2 and 3 trial needs. This role will focus on initial MSA contract negotiations, rate cards, scope review and issue escalation associated with assigned vendors. This individual will participate in the standardization of Clinical Operation processes and will ensure sourcing objectives are aligned with corporate/operational goals. Key Responsibilities Collaborate with business partners to research and evaluate potential vendors based on their capabilities, pricing, and service level agreements Build strong relationships with key vendors Conduct ongoing assessment of vendor relationship performance through KPI review, vendor performance trend analysis, and administration/interpretation of stakeholder satisfaction surveys Drive and improve existing systems and processes Maintain knowledge of market trends for assigned key vendors Lead and conduct high visibility and competitive negotiations Support sourcing policies, contingency plans, and additional strategic initiatives established by the Vendor Strategy &amp; Management Lead Support Clinical Operations Vendor Sourcing and vendor governance related meetings Hold vendors accountable to performance goals/agreements Drive annual third-party vendor spend savings while improving processes and vendor relationships Closely manage deliverable timelines and cross-functional input to keep reviews, decisions, and initiatives on track Participate in the continuous improvement process for programs within purview Lead/participate in vendor strategy and budget discussions Collaborate on contracts review to verify compliance with MSA, discount structures, and performance requirements Ideal Candidate Knowledge of the drug development process in complex indications for large global programs Strong understanding of contracting process and ability to negotiate and manage contractual arrangements. Ability to prepare bids, requests for quotes, and proposals Excellent communication skills with an ability to present to a variety of stakeholders and tailor messages accordingly Proven ability to influence and make decisions in a matrixed environment Comfortable leading candid conversations on vendor delivery and driving to resolution of performance challenges Partnering with study teams and vendors to effectively manage conflicting viewpoints and challenging situations with minimal negative impact Experience in problem solving capabilities; can see a problem from multiple angles and provide viable, innovative options for resolution Demonstrated ability to effectively manage priorities to achieve goals and support unplanned work Bachelor’s degree in management, finance, or related field 5 years of relevant experience working in a pharmaceutical/biotech company or CRO Excellent leadership skills and big-picture mentality Ability to keep pace with a fast-moving organization Availability to participate in calls across multiple international time zones Exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 20% The anticipated salary range for candidates for this role will be $150,000 to $160,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Clinical Operations Vendor Manager

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Director, Data Engineering &amp; Analytics to be a hands-on, individual contributor leading the design, implementation, and evolution of Apogee’s new enterprise Data Lakehouse and analytics ecosystem. This role will be the primary internal owner of our Data Lakehouse, delivered in partnership with a Systems Integrator, and will initially focus on Clinical Development and Clinical Operations use cases (e.g., study oversight, medical monitoring, operational performance). Over time, the platform will expand to support Technical Operations, Commercial, Medical Affairs, and Finance. Key Responsibilities Data Lakehouse Strategy, Design &amp; Implementation Serve as the primary owner of Apogee’s Data Lakehouse architecture, roadmap, and implementation, in close partnership with a Systems Integrator Define the data platform to support Clinical Development and Clinical Operations, with a clear path to extend to Technical Operations, Commercial, Medical Affairs, and Finance Design and oversee data ingestion, transformation, and storage for structured and semi-structured data from key Apogee sources, including external CRO systems (e.g., EDC, CTMS, safety, statistical outputs) Establish and maintain subject area data models and semantic layers tailored to clinical and operational use cases Ensure the platform is designed and operated in alignment with Apogee’s GxP, 21 CFR Part 11, SOX Controls, and other regulatory/compliance expectations, where applicable Data Engineering, Modeling &amp; Governance Design, build, and maintain end-to-end data pipelines (ingestion, transformation, curation) into the Data Lakehouse using modern data engineering practices Develop and maintain data models that serve Clinical Development, Clinical Operations, and later Tech Ops and Commercial / Med Affairs / Finance Implement data quality, lineage, and metadata practices, working with business data owners to define critical data elements and trusted metrics Contribute to defining data governance at Apogee, including data ownership, stewardship, and standardized KPI and metric definitions across functions Analytics, BI &amp; Visualization Design and build dashboards / analytic views that support key functional area use cases Define reusable data marts and semantic models that enable self-service analytics for Clinical and, over time, other functions Cross-Functional Leadership &amp; Change Management Act as a trusted partner to Clinical Development, Clinical Operations, Biometrics, Medical Monitoring, and other functions, translating their questions into implementable data and analytics solutions Work closely within IT (Infrastructure and Security), QA, and business stakeholders to support any required validation, testing, and controlled releases of data and analytics capabilities Communicate roadmaps, status, risks, and dependencies clearly and regularly to technical and non-technical stakeholders, including senior leadership Drive adoption and literacy around the Data Lakehouse and BI tools by developing documentation, providing training/enablement for key users, and promoting best practices Help define the future operating model for data and analytics at Apogee, including when and how to scale into a broader team Ideal Candidate 10+ years of experience in data engineering, data platform, or analytics roles, with meaningful experience owning or leading a modern cloud data platform (Data Lakehouse or cloud data warehouse) Bachelor’s degree (or equivalent professional experience) in Life Sciences, Information Systems, Engineering, or related field Proven track record as a hands-on senior level individual contributor, comfortable both setting strategy and implementing technical solutions Experience with cloud-based data platforms (e.g., Databricks, Snowflake, BigQuery, or similar) and modern data stack components Strong expertise in data modeling and ETL/ELT for analytics and reporting, including building reusable, production-grade data assets Experience working closely with integration teams (ideally with MuleSoft or similar) and understanding how operational integrations and data pipelines intersect Prior experience in biotech / pharma / life sciences is strongly preferred, especially supporting Clinical Development, Clinical Operations, Biometrics, or Medical Monitoring Familiarity with data from CROs and clinical systems (e.g., EDC, CTMS, safety, lab, statistical outputs) and integrating these into a centralized data environment Experience working in regulated environments (e.g., GxP, 21 CFR Part 11, HIPAA) and supporting audit/inspection readiness is highly desirable Exposure to Apogee-relevant systems is a plus (e.g., Veeva Vault applications, Egnyte GxP repositories, SAS server, NetSuite) Strong proficiency in SQL and at least one data engineering language (e.g., Python or Scala) Hands-on experience with data pipeline and orchestration tools (e.g., Airflow, Azure Data Factory, dbt, or similar) and CI/CD concepts for data workloads Solid understanding of data architecture patterns (data lakes, lakehouses, warehouses, dimensional modeling, semantic layers) Experience integrating data from file repositories (SharePoint, Egnyte) and external partners (CROs, cloud vendors, etc.) Strong understanding of data security, privacy, and access control in an enterprise setting, and how these intersect with GxP and other compliance requirements Strategic yet pragmatic; able to start from a greenfield environment and design a phased, realistic roadmap Excellent communication and storytelling skills, capable of framing data and platform decisions in business terms for clinical and executive stakeholders Demonstrated ability to lead through influence, collaborating effectively with integration, infrastructure, security, QA, and business teams without direct reporting lines High ownership and bias for action, comfortable operating in a fast-paced, high-growth clinical-stage biotech environment Interest in eventually building and leading a small data team, while being fully comfortable as a hands-on individual contributor in the near term Ability and willingness to travel up to 20%, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $220,000 - $235,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Data Engineering & Analytics

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a&nbsp;Senior Director, KOL and Advocacy Engagement. This is a&nbsp;senior position within the commercial organization that will focus on&nbsp;the&nbsp;identification&nbsp;and&nbsp;cultivation of&nbsp;professional&nbsp;relationships with&nbsp;commercial&nbsp;key opinions leaders (KOL) within the&nbsp;Atopic Dermatitis (AD) community&nbsp;and&nbsp;national and international&nbsp;patient advocacy groups. KOL&nbsp;engagement&nbsp;and planning will support commercial and marketing strategy, messaging, and educational needs through insight generation, advocacy collaboration, and strategic leadership of key initiatives such as advisory boards, speakers bureau development, congress activities, and other commercial initiatives. In this highly visible role, you will work with advocacy groups to gain insights, discuss priorities, and lead partnerships on various projects. As an integral part of Apogee Therapeutics commercial team you will work closely with internal and external cross functional partners to compliantly support commercial strategy and educational opportunities through KOLs. Key Responsibilities Identify,&nbsp;develop,&nbsp;and&nbsp;maintain&nbsp;professional&nbsp;relationships with&nbsp;international, national, and regional&nbsp;Dermatology and Allergy KOLs&nbsp;to generate insights,&nbsp;and participate&nbsp;in&nbsp;approved&nbsp;Apogee&nbsp;consulting opportunities such as&nbsp;advisory boards,&nbsp;speaker&nbsp;bureau, leadership meetings at congresses, and reviewing of marketing materials, etc.&nbsp;&nbsp; Lead&nbsp;commercial KOL influence-mapping initiatives by developing profiles and objective-based engagement / communication plans for each assigned KOL. &nbsp; Solicit, monitor, and interpret pre-determined KOL insights through compliant, field-based, 1v1 KOL interactions about current and future disease and treatment management patterns that&nbsp;impact&nbsp;the development of commercial and marketing strategy, initiatives, and resources. &nbsp; Act as a liaison between KOLs and Apogee including connections with cross functional partners and other healthcare professionals. &nbsp; Compliantly align with field partners such as Medical Affairs on complementary strategic initiatives with shared KOLs. &nbsp; Collaborate with Marketing to provide insights&nbsp;to&nbsp;refine positioning, disease campaigns, and&nbsp;assist&nbsp;in the development of strategies and messaging to deliver&nbsp;disease and treatment education. &nbsp; Develop and execute strategies for KOL congress participation supporting development and execution of commercial KOL meetings and selecting commercial speakers. &nbsp; Support identification of KOLs&nbsp;to develop national&nbsp;speaker&nbsp;bureau.&nbsp;&nbsp;&nbsp; Strategically assess execution of the&nbsp;speaker&nbsp;bureau supporting program and speaker effectiveness and&nbsp;utilization, speaker training, and evolving disease and&nbsp;brand&nbsp;(following&nbsp;product&nbsp;approval)&nbsp;content to meet education needs within the AD community.&nbsp;&nbsp;&nbsp; Compliantly lead the planning and execution of Apogee commercial advisory boards through advisor identification, development of meeting&nbsp;objectives, and development of meeting content to generate key insights. &nbsp; Operate to the&nbsp;highest&nbsp;standards in alignment of&nbsp;Apogee’s code of ethics and compliance SOPs, ensuring all interactions with KOLs are consistent with commercial, regulatory, and legal guidelines.&nbsp;&nbsp; Compliantly work with National and International Patient advocacy groups on sponsorships, and support advocacy groups consistent with commercial and regulatory guidelines.&nbsp; Assist with the design and execution of market research projects or other marketing initiatives as needed. Ideal Candidate Bachelor’s Degree or equivalent. Advanced life science degree a plus.&nbsp; Minimum 10 years of industry experience; marketing or clinical experience in dermatology or a related therapeutic area a plus. Proven track record of consistently achieving and exceeding expectations in current and prior positions. Patient and customer centricity by developing and fostering valued relationships with KOLs based upon active listening and acquiring and assimilating insights across applicable clinical and scientific domains. Ability to influence for impact using empathy and resilience to build credibility, trust, and influence with KOLs. Strategic mindset including the anticipation and interpretation of KOL beliefs to understand opportunities to support commercial and marketing strategy, messaging, and resources. Collaboration by building trusted relationships with cross functional partners committing to shared responsibility of customer and patient centric goals. Deep knowledge of dermatology clinics understanding referral patterns and networks. Excellent communication skills with proven ability to present to large and small audiences. Excellent product and disease fluency including the ability to develop deep knowledge of the therapeutic area and apply it to engage KOLs in support of commercial and marketing strategy. Strategic, passionate, self-starter who takes initiative and demonstrates the ability to lead through change, ambiguity, and complexity. Drives results by setting, communicating, and adjusting priorities to achieve evolving business needs or objectives. Strong understanding of the laws, regulations and rules governing the pharmaceutical industry, and history of ethical and compliant behavior. Must work well in large and small teams, comfortable working remotely. Position requires up to 50% travel including mandatory in-person attendance at Apogee All Hands meetings typically held two times per year, and travel to functional meetings and industry conferences.&nbsp;&nbsp; The anticipated salary range for candidates for this role will be $270,000 - $300,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Director, KOL and Advocacy Engagement

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. Key Responsibilities Key contributor on regulatory submissions and communication with global regulatory authorities Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies Evaluate alternative or innovative approaches to statistical methods and study design Build relationships with CROs and other external partners to achieve results for specific project needs Ensure the delivery of high quality and timely reports to project teams and clinical trial team Ideal Candidate PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered A minimum of 8 years’ experience in progressive and relevant clinical trial experience Experience with phase 3 study and regulatory submission is preferred Experience leading teams and working in a matrix organization Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly Experience managing CROs and other data vendors Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment Ability to keep pace in a fast-moving organization and navigate ambiguity Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment Knowledge and proficiency in SAS or R and other industry computational tools Knowledge of CDISC standard including SDTM, ADaM Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience in planning, running and documenting simulations, including clinical trial simulations Experience working with in a remote virtual environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel 10-15% or as needed by the business The anticipated salary range for candidates for this role will be $195,000-$235,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Biostatistics

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, QC Data and Materials Management to support key QC infrastructure processes. This role has oversight of QC critical reagents and reference standard management and has primary responsibility for QC data management and administration of the QC LIMS system. The ideal candidate has a broad range of QC experience in the biologics manufacturing industry and is knowledgeable about GMP laboratory operations and systems management, including LIMS systems, stability study management, and reference standard management. Key Responsibilities&nbsp; QC materials oversight, including: Manage lifecycle of QC critical reagents and reference standards at all stages of product development Synchronize change management of critical reagents/materials and reference standards across multiple vendor sites in alignment with program team requirements Perform technical review of material qualification and re-evaluation protocols, reports, and analytical data received from vendors Coordinate QC material and sample shipments to support analytical testing activities at vendor sites Author controlled documents to support QC systems and infrastructure QC data management oversight, including: Overall responsibility for LIMS system administration for QC team Manage QC LIMS system changes, including updates to system master data (specifications, methods, reporting units) and workflows (automated data parsing/upload, data approval, reporting workflows) Support computer system validation and change control activities for LIMS system upgrades and enhancements in partnership with QA team and SaaS provider(s) Manage stability protocol configurations and updates in LIMS Ideal Candidate&nbsp; BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.) 10+ years of biotech industry experience in QC operations, systems, or analytical support roles Understanding of analytical techniques relevant to monoclonal antibody release and stability testing Experience in relationship management with external analytical test sites Ability effectively prioritize and manage multiple projects Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing Excellent communication skills; able to collaborate effectively across multidisciplinary teams Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Self-direction, motivation, problem solving and decision-making abilities Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations Collaborate with the vendor on on-going system issues, upgrades, and maintenance Position requires travel up to 6-8 times per year, based on business needs The anticipated salary range for candidates for this role will be $170,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, QC Data and Materials Management

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Statistical Programming. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests. Key Responsibilities Serve as a lead statistical programmer on one or more clinical studies Provide statistical programming oversight to programming vendors Review and validate datasets and TFLs programmed by vendors Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate Participate in developing and implementing statistical programming processes and standards. Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective Build and mentor a team of programmers to support clinical trials and pipelines Generate ad hoc analyses on ongoing basis Ideal Candidate Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry Advanced SAS programming skills and experience in other statistical software, such as R, etc. Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies Phase 3 and BLA submissions experience preferred Excellent organizational skills and ability to prioritize tasks Excellent communication and interpersonal skills Experience managing CROs and other data vendors Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment Ability to keep pace in a fast-moving organization Advanced knowledge of state-of-art statistical programming methods in clinical study setting Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience working in a remote virtual environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel per business needs (at least 4 – 8 times per year) The anticipated salary range for candidates for this role will be $185,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Statistical Programming

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a motivated Director, Clinical Pharmacology, to join our growing Clinical Development team. In this role, you will lead clinical pharmacology programs in immunology &amp; inflammation, providing strategic planning for drug development activities in line with departmental strategies, goals, and objectives. You will have a seat at the table to influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum, ranging from first-in-human through approval. You will develop and help implement quantitative approaches to drug development programs. You will&nbsp;work in close collaboration with different functions, including preclinical toxicology, preclinical pharmacokinetics, translational medicine, clinical development, clinical operations, and regulatory affairs. The position requires strong communication skills to lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners. Key Responsibilities Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise to program teams, regulatory, and senior leaders to guide critical decisions and inform development plans Support pediatric development, including protocol development and dose selection. Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response to support dose selection and overall development for clinical programs Provide clinical pharmacology timelines to program teams and negotiate with other functions on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance) Lead authoring of clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, BLAs, and responses to regulatory agency comments Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the emerging Apogee pipeline Ideal Candidate PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required 5+ years of direct industry experience in conducting clinical stage drug development Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics Experience in biologic drug development preferred, and/or immunology and inflammation (I&amp;I) a plus Experience with late-stage development (Phase 2/3) preferred Fluency in model-informed drug development, with hands-on modeling and simulation experience highly preferred (e.g. NONMEM, R, Phoenix NLME, MATLAB, etc.) Experience working with external CROs Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools) Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation Ability to work in cross-functional teams within a highly dynamic environment Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Up to 15-20% travel is required to company All Hands meetings and development team meetings The anticipated salary range for candidates for this role will be $230,000 to $260,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Clinical Pharmacology

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Director of Clinical Systems as the strategic leader leading, deploying and optimizing of multiple clinical systems within the Clinical Operations organization. This position will strategically evaluate business needs against clinical systems capabilities and partner in cross-functional collaboration activities with Information Technology (IT), internal stakeholders, external clinical system vendors and Clinical Research Organizations (CROs) to develop, manage and support the use of clinical systems including but not limited to Risk Based Monitoring, (RBM), Interactive Response Technology (IRT), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), and Patient Reported Outcomes, (ePRO/ eCOA). Additionally, this position will manage and assist with developing and implementing clinical system (business and technical) processes as they apply to SOPs, Work Instructions, tools, templates, and training. The position may be responsible for direct report(s) who manage clinical systems. Key Responsibilities Lead Clinical Operations on system related initiatives and throughout a clinical system’s life cycle Acts as primary business change agent to ensure adoption of new capabilities and business processes related to clinical systems and technology. Articulate global requirements, trial designs and business processes used across various therapeutic areas to support development of functional requirements for new or enhanced clinical systems Develop and present to leadership business cases around clinical system related needs and technologies to support clinical trials sponsored by Apogee. Partner cross-functionally to define standard operational terminology and data conventions used for clinical systems. Work with business process and system owners to define user roles, permissions, and training requirements. Serve as the business process owner for some clinical operations systems as required. Oversees and supports activities related to system builds, integrations and implementation, as needed (e.g., writing and/or executing UAT scripts) Partner with cross-functional team members (e.g., Biometrics, Tech Ops/Clin Supplies, QA, IT, Procurement) to identify and select clinical system vendors, and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT). Participate in contracting and budget management activities including establishing an initial Scope of Work (SOW) and Change Orders, as applicable Supports/oversees kickoff meeting(s) for each respective trial with the system/technology supplier and internal cross-functional team members Ensures completion of system deliverables within established timelines including but not limited to CSV requirements and vendor qualification. Provide oversight of the system vendors, monitoring and addressing gaps in both quality and timeliness of their work Lead and manage resolution of issues and remediation activities with stakeholders and the clinical system vendor Identify root cause of performance issues, determine the appropriate remediation, and implement solutions, as required. Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems. Serves as an escalation point for study teams to drive resolution of issues, as appropriate. Lead and collaborate in developing solutions and measuring their effectiveness. Evaluate evolving industry trends and best practices and assess their impact on current processes Ensure compliance with applicable SOP’s Responsible for executing audit trail reviews of the clinical systems and additional compliance related activities, as required. Develop standard reports and metrics for system users and internal stakeholders and clinical system vendors. Provides functional and technical support and expertise for audits and inspections with respect to the clinical systems Ideal Candidate Bachelor’s degree required Minimum of 15 years of experience working in or partnering with a Clinical Operations Organization Minimum of 10 years of experience in clinical systems related management including: Veeva systems implementation and management IxRS/IRT and related systems CTMS and related systems Minimum of 5 years of experience with ePro/eCOA experience Demonstrated familiarity and use of the System Design Life Cycle (SDLC) Successful record in leading the implementation of clinical systems Working knowledge of Good Clinical Practices and Health Authority regulations governing clinical trial execution Detail-oriented and able to manage many projects simultaneously Experience with documentation in a regulated environment Meeting management, facilitation, and negotiation skills Extensive vendor management experience Excellent project management and organizational skills, attention to detail and follow through Sound problem resolution, judgment, and decision-making abilities Highly organized with a strong attention to detail, clarity, accuracy, and conciseness Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Self-direction, motivation, problem solving and decision-making abilities Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations Collaborate with the vendor on on-going system issues, upgrades, and maintenance Position requires travel up to 3-4 times per quarter, based on business needs The anticipated salary range for candidates for this role will be $200,000 - $225,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Clinical Systems

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Medical Director to oversee clinical execution and medical monitoring of dermatology studies. As part of a growing clinical development team, you will be responsible for seamless execution of studies and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitor activities. If you thrive in a fast-paced environment and seek the opportunity to advance clinical programs into later stages of development this role is for you! Key Responsibilities&nbsp; Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan Support the design of trials and develop protocols and other relevant documents for individual studies Support all the start-up activities related to the assigned Dermatology clinical study Oversee day-to-day clinical and medical execution of studies Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan Partner with clinical operations on site selection, recruitment, and CRO management Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable Ideal Candidate&nbsp; Education – MD is required Experience in clinical development within the Immunology &amp; Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology 2+ years’ industry experience as a medical monitor and/or medical director Experience working on phase 2 and 3 clinical studies required Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability to travel approximately 15% to All Team meetings, functional meetings, study-related activities, and medical conferences The anticipated salary range for candidates for this role will be $280,000 – $325,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Director, Clinical Development - Dermatology

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Vice President, Head of Pharmacovigilance. In this newly created position, you will be responsible for leading drug safety strategy and operations across Apogee’s pipeline. As a senior leader in the Clinical Development and Medical Affairs (CDMA) Organization, you will define pharmacovigilance policies, ensure regulatory compliance, and provide expert guidance on safety risk management. This role is critical in supporting regulatory approvals, patient safety, and long-term drug development strategies. Additionally, you will play a key role in the oversight and strategic direction of drug safety and pharmacovigilance activities to ensure high-quality data generation to support the safety and efficacy of our products in development. Key Responsibilities&nbsp; Play a hands-on leadership role to build and manage Apogee’s global pharmacovigilance strategy in close collaboration with the Chief Medical Officer and the Head of Clinical Development and Medical Affairs. Oversee compliance with FDA, EMA, MHRA, PMDA and ICH pharmacovigilance requirements, overseeing adverse event reporting, safety update reports and risk management plans.&nbsp; Work cross functionally with clinical development, clinical operations, medical affairs, and commercial teams to provide expertise and integrate pharmacovigilance into broader corporate strategy Represent the company in discussions with health authorities, responding to inquiries, audits, and inspections related to drug safety, and participate in EOP2 meetings and interactions. Oversee safety signal detection, aggregate analysis, risk evaluation, and mitigation strategies across the pipeline at all stages of development to determine benefit-risk profiles. Contribute knowledge of relevant drug class and/or competitor safety issues, and provide input to study related documents (i.e. protocols, IBs, DSURs/ASRs). Oversee PV Operations team responsible for case processing, aggregate safety reporting, and pharmacovigilance data analysis, ensuring operational excellence in drug safety surveillance. Oversee PV related vendor management. Lead and oversee the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards. Review safety content of scientific publications such as posters, abstracts, and manuscripts. As Apogee grows build and lead a high-performing pharmacovigilance team, focused on delivering scientific rigor, compliance, and innovation. Ideal Candidate&nbsp; MD degree is required Minimum&nbsp;15+ years&nbsp;of pharmacovigilance experience in the biopharmaceutical industry Must be a self-starter willing to play a hands-on role in establishing the PV function Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH) Exposure to biologics, medications for I&amp;I conditions including dermatology a plus Experience in the following areas are required: leading regulatory submissions, including the ISS, and safety related sections of the NDA and MAA as well as label development interacting with regulatory agencies on safety-related matters, including FDA and EMA negotiations and EOP2 meetings and interactions managing safety databases, case management systems, and pharmacovigilance software Strong leadership and communication skills, ability to influence and define corporate safety policies Alignment with Apogee C.O.R.E. (Caring, Original, Resilient and Egoless) values Position requires up to 20% travel to company and team meetings, conferences, etc. The anticipated salary range for candidates for this role will be $375,000 - $425,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Vice President, Head of Pharmacovigilance

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Senior Research Associate, Preclinical and Clinical Biomarkers&nbsp; Position Summary:&nbsp;The Department of Research and Translational Medicine is&nbsp;seeking&nbsp;a&nbsp;highly motivated and detail-oriented&nbsp;Research Associate/Senior RA, Preclinical and Clinical&nbsp;Biomarkers&nbsp;to support our growing research and development efforts. The ideal candidate will have a strong background in immunoassay development and&nbsp;qualification, with hands-on experience in ELISA and MSD-based assays.&nbsp;Experience handling and testing clinical patient samples, with a strong understanding of best practices for sample integrity and compliance.&nbsp;This role requires a collaborative team player who can interpret complex data sets, implement best practices, and&nbsp;maintain&nbsp;high standards&nbsp;of quality and documentation.&nbsp; &nbsp; Key Responsibilities:&nbsp; Design, develop, and qualify immunoassays including ELISA and MSD platforms to support research and product development. Experience with assay automation preferred but not required. Analyze and interpret complex biological data sets with precision and scientific rigor. Apply best practices to minimize assay variability and ensure reproducibility. Maintain detailed and accurate records of experimental procedures and results in accordance with quality control standards. Maintain the inventory of samples and associated paperwork according to our operating procedures Assists with identifying needs and sourcing of reagents, samples, and other critical materials Collaborate cross-functionally with other scientists and departments to support project goals. Contribute to troubleshooting and optimization of assay protocols. Ensure compliance with internal SOPs and regulatory guidelines.&nbsp; &nbsp; Qualifications:&nbsp; Bachelor’s degree in Biology, Molecular Biology, Biochemistry, or a related scientific discipline with 3–5 years of industry experience, or a Master’s degree with at least 2 years of relevant experience. Demonstrated expertise in immunoassay development and qualification, specifically ELISA and MSD. Strong analytical skills with the ability to interpret complex data and draw meaningful conclusions. Experience implementing quality control measures and maintaining scientific documentation. Excellent communication and organizational skills. Ability to work independently and as part of a collaborative team in a fast-paced environment. Ability and willingness to travel including a minimum of 2 times per year for company-wide meeting&nbsp; Ability to work onsite up to 5 days per week in the Apogee lab located in Boston, MA&nbsp; &nbsp; The&nbsp;anticipated&nbsp;salary range for candidates for this role will be $95,000- $110,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Research Associate

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a highly motivated and results-oriented Manager, Supply Chain Management. In this position, you will be responsible for the end-to-end material management of cGMP materials as well as managing the supply chain on single or multiple clinical studies working closely with Clinical Operations, Regulatory Affairs, Quality, Development, Manufacturing, Analytical Development and the Supply Chain Management team. This includes leading complex studies that will require global interactions, and ensuring changes in supply configuration, trial design, enrollment timelines, manufacturing availability, and regulatory requirements are considered.&nbsp; Additionally, you will coordinate and lead supply activities with both internal and external partners and serve as a key point of contact with multiple functional areas. The position is fully remote and reports to a senior member of the Supply Chain Management team. Key Responsibilities Maintain inventory oversight of applicable drug supply (Cell Banks (CB), Drug Substance (DS) and Drug Product (DP)) in collaboration with other functions in Development, Manufacturing &amp; Supply (DMS) Support logistics execution and oversight of DS and DP supply with other trade compliance activities as needed Assist with assembly of bulk devices and allocation across studies as applicable Develop and execute Demand &amp; Operations Planning (D&amp;OP) with Supply Chain Management team and other cross-functional members, such as Clinical Operations and Manufacturing Utilize forecasting tools to develop clinical supply forecasts to enable supply planning per assigned studies and/or bulk supply across studies Develop packaging and supply strategies to meet clinical study needs, maximize supply efficiency, and minimize waste while maintaining a low risk profile Clearly communicate expiry requirements based on labeling strategy and supply plans with Analytical Development Represent Apogee with selected external providers to develop project requirements and provide project management oversight during planning and execution Manage oversight of packaging and labeling jobs for assigned studies in collaboration with GMP Quality Assurance Develop requests for proposals for labeling, packaging, storage, and distribution; analyze quotes from prospective providers and make recommendations to management Review vendor invoices and provide input for accruals and budget as applicable Coordinate US and international distribution and logistics for clinical studies based on supply plans Drive development of Interactive Response Technology (IRT) user requirement specifications and acceptance testing Develop and provide input for SOP’s and work instructions required to optimize Supply Chain operations Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance Ideal Candidate S/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in supply chain management; certification in Supply Chain Management or Project Management a plus Experience with inventory and Supply Chain Management for complex global clinical trials, experience with upstream material management and device assembly are a plus Knowledge of import/export requirements and significant experience with international clinical supply Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP) Proven ability to manage multiple projects, proactively identify and resolve issues using strong attention to detail and problem-solving skills Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity Excellent communication and influencing skills, strong collaboration skills Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Strong knowledge of Microsoft Office, including Excel, Word and PowerPoint Smartsheet experience is strongly preferred. PowerBI, experienced excel (macros) and/or Tableau is a plus Position requires up to 20% travel (domestic and international) including 2 times per year for All Hands meetings The anticipated salary range for candidates for this role will be $145,000-165,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Manager, Supply Chain Management

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple projects, providing technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. Key Responsibilities Contributor on regulatory submissions Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies Evaluate alternative or innovative approaches to statistical methods and study design Build relationships with CROs and other external partners to achieve results for specific project needs Ensure the delivery of high quality and timely reports to project teams and clinical trial team Ideal Candidate PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered A minimum of 8 years’ experience in progressive and relevant clinical trial experience Experience with phase 3 study and regulatory submission is preferred Experience leading teams and working in a matrix organization Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly Experience managing CROs and other data vendors Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment Ability to keep pace in a fast-moving organization and navigate ambiguity Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc. Knowledge and proficiency in SAS or R and other industry computational tools Knowledge of CDISC standard including SDTM, ADaM Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience in planning, running and documenting simulations, including clinical trial simulations Experience working in a remote virtual environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office The anticipated salary range for candidates for this role will be $195,000 - $215,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a conscientious patent attorney with considerable experience in various aspects of intellectual property in the life sciences industry to join our IP team. In this newly created role, the Director, Patent Attorney will be responsible for preparing and prosecuting patent applications in the life sciences space, with a particular focus on antibodies, and will also be expected to conduct patent landscape analyses, provide patentability guidance and identify and help address any freedom-to-operate risks. The ideal candidate must be willing to take initiative, be a team player and possess strong interpersonal and communication skills.&nbsp;&nbsp;&nbsp; Key Responsibilities Prepare and prosecute patent applications, including drafting applications and responses to Office Actions before the U.S. Patent and Trademark Office Coordinate patent filing and prosecution strategy ex-US (globally) and instruct foreign counsel accordingly&nbsp; &nbsp; Work alongside scientific and technical colleagues to identify patenting opportunities and convert innovative ideas into patent applications&nbsp; Conduct patent and patent application landscape analyses and provide guidance to stakeholders Perform patentability analyses and communicate guidance to stakeholders Perform freedom-to-operate assessments, identify and investigate any potential risks and assist with any risk-mitigation measures&nbsp; Communicate patent-related information clearly, concisely and carefully with colleagues across functions Ideal Candidate An advanced degree in Biotechnology,&nbsp;Biochemistry, Cell Biology,&nbsp;Molecular Biology, Biomedical&nbsp;Engineering&nbsp;or related field&nbsp;&nbsp; A Juris Doctorate (J.D.) degree and membership in a state bar Registration as a patent attorney with the US Patent &amp; Trademark Office 5+ years of experience as a patent attorney at a law firm or in-house in the biotech or pharmaceutical industry (preferably a combination of both) Excellent written and verbal communication skills&nbsp; Exceptional organizational skills&nbsp; Ability to work in a rapidly changing environment and manage competing priorities&nbsp; Keen attention to detail&nbsp; Strong work ethic with the willingness and ability to take initiative and think and work independently in a fast-paced environment Ability to think creatively and strategically&nbsp; Ability to collaborate effectively with team members across the organization as well as external counsel&nbsp; Proficiency with SharePoint, and Microsoft Office programs such as Word, Excel, Teams, and PowerPoint&nbsp; Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $245,000-$275,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Patent Attorney

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp;We are seeking a Sr. CMC Project Manager to join the Technical Operations Program &amp; Strategy team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more CMC Programs. This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment and thrive in a culture of growth and camaraderie, this role is for you.&nbsp; Key Responsibilities Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint Maintain and communicate a current overview of Tech Ops documentation status and issues, including weekly dashboards to present to the upper management Responsible for migration of relevant Tech Ops documentation into the Veeva Quality System Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth Provide Project Management support for one or more CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track Responsible for purchase order initiation in NetSuite, review and approval of vendor accruals and invoices Responsible for tracking all outsourced activities Ideal Candidate Bachelor’s degree in science 5+ years of experience in biotech or pharmaceutical industry with 3+ years of biologics development and manufacturing experience required 2+ years of Technical Operations/CMC experience Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3) Experience with Process Characterization and PPQ is a plus Good technical knowledge of CMC development (Upstream, Downstream, Analytical), Supply Chain, CMC Regulatory Affairs, Quality, GMP requirements Extensive knowledge of Smartsheet and Microsoft Timeline a must Veeva experience is highly desired Highly organized with meticulous attention to detail Ability to multi-task and keep pace with a fast-moving organization Ability to participate in calls across multiple international time zones Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. Will require travel to the Apogee lab in Boston, MA up to one week per year The anticipated salary range for candidates for this role will be $160,000 - $175,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Sr. CMC Project Manager

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Medical Director to support clinical execution and medical monitoring of dermatology studies. As part of a growing clinical development team, you will be responsible for seamless execution of studies and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitor activities. This position will work closely with senior clinical leaders and clinical scientists. If you thrive in a fast-paced environment and seek the opportunity to advance clinical programs into later stages of development this role is for you! &nbsp; Key Responsibilities&nbsp; Serve as a primary Sponsor medical representative for assigned clinical trial, working closely with the CRO medical monitor and cross-functional partners, and pharmacovigilance on study execution including but not limited to safety reporting, escalation for medical issues, development and execution of the Medical Monitoring Plan Contribute to protocol development, study documents, operational plans, and other relevant documents for individual studies Support all the start-up activities related to the assigned Dermatology clinical study including investigator training, vendor discussions, cross-functional team reviews Oversee day-to-day clinical and medical execution of studies including direct medical review of eligibility, safety events, and clinical data Work closely with cross-functional colleagues, including, but not limited to regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan and study milestones in alignment with business goals Partner with clinical operations on site selection, recruitment, site relationship management and CRO management Partner with medical affairs to build and maintain strong relationships with PIs by participating in KOL interactions and scientific engagement activities &nbsp; Ideal Candidate&nbsp; Education – MD is required, Dermatologist strongly preferred Experience in clinical development and/or study design and execution within the Immunology &amp; Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology 2+ years’ pharma/biotech clinical development or medical affairs with study execution experience preferred Experience working on phase 2 and 3 clinical studies strongly preferred Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires approximately 35% including mandatory in-person attendance at &nbsp;All Team meetings typically held twice per year. Travel will also be required to attend functional meetings, study-related activities, and medical conferences. &nbsp; The anticipated salary range for candidates for this role will be $270,000 – $310,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Director, Clinical Development – Dermatology

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Clinical Strategic Excellence to enable clinical decision-making and execution of the company’s clinical strategy. The successful candidate will collaborate with and contribute to teams within and beyond the Clinical organization to drive strategic and operational initiatives through data analysis and synthesis, structured problem-solving, and cross-functional leadership. You will contribute to, and help facilitate, discussions regarding clinical development, trial design, trial results disclosure, and scenario planning, and foster coordination across functions as we operationalize our strategy. This role requires a strong scientific or medical background along with exceptional analytical and communication skills, and excellent project management to manage multiple concurrent workstreams. Key Responsibilities Collaborate with the Clinical Strategic Excellence team to support the development and execution of the company’s clinical strategy Drive analysis and synthesis of both quantitative and qualitative data, including clinical trial data, scientific literature, and insights from the competitive landscape, leveraging input from multiple sources, including new insights from the Business Development &amp; Strategy, Clinical Development, and Medical Affairs teams Partner with cross-functional teams to inform strategic recommendations with data-driven insight Optimize processes within the Clinical organization to enable program execution and further company strategy Support external communication about our clinical programs, including coordination of operations to support clinical data releases and development of presentations for leadership, board meetings, and external stakeholders Contribute to clinical strategy working groups and other ad hoc Clinical initiatives, including in-person workshops and meetings Ideal Candidate Advanced degree (MD, PhD, MBA, MS) with technical training in science/medicine preferred MD or PhD: 2+ years of experience in biotech or pharmaceutical industry, with broad and comprehensive understanding of different systems, functions, and processes within clinical development MS or MBA: 4+ years of experience in biotech or pharmaceutical industry, with strong knowledge of clinical development processes Experience in immunology &amp; inflammation and/or antibody development preferred Strong analytical and problem-solving capabilities, with ability to synthesize complex or unstructured medical and scientific concepts and translate them into implications Strong stakeholder management and presentation skills; strong track record of working cross-functionally to achieve results Highly organized with strong project management skills; ability to prioritize and manage multiple projects simultaneously Strong written and verbal communication skills, with demonstrated ability to collaborate across diverse stakeholders and cross-functional teams Thrives in a fast-paced, dynamic environment; eager to learn and grow in a strategic and operational role Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 20% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office The anticipated salary range for candidates for this role will be $175,000-$190,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Strategic Excellence

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.). This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. This role is essential in supporting our mission to develop and deliver differentiated biologic therapies to patients in need. Key Responsibilities Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality Ensure all personnel are adequately trained in GMP requirements and quality procedures Keep comprehensive and accurate records and reports of all quality assurance activities Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork Prepare and support the organization for regulatory authority inspections and maintain inspection readiness Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes Ideal Candidate A bachelor’s degree in relevant scientific discipline or equivalent is required A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971.In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements Experience with analytical instrumentation, methods, validation, and investigations including stability program management Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities Position requires up to 20% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year&nbsp; The anticipated salary range for candidates for this role will be $160,000-$185,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp;&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, GMP Quality Assurance

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a dynamic and experienced MSAT Associate Director to support late-stage development through launch/commercialization activities. Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies. This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale.&nbsp; Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing &amp; Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.&nbsp;&nbsp; &nbsp; Key Responsibilities Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations Analyze process and manufacturing data to understand and optimize process performance Develop process characterization and PPQ strategies and documentation Support regulatory activities including submissions and site inspections from preparation through execution Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team Author and review internal procedures, reports, and presentations, as needed Ideal Candidate PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience 7+ years of biologics development and manufacturing experience Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.) Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support Experience with process and economic modeling of DS manufacturing processes Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment Ability to multi-task and keep pace with a fast-moving organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Availability to participate in calls across multiple international time zones Ability and willingness to travel up to 25%, including domestic and international sites, attendance at Apogee All Hands meetings is required, typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $175,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Manufacturing Science and Technology

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Director, Cell Culture Development to join the TechOps team.&nbsp;&nbsp;This role will be responsible for managing CDMO(s) to develop/implement processes that enable robust production of Drug Substance (DS) for protein-based biologics. This interdisciplinary position will provide technical leadership in cell culture processes, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities. The role will be responsible for advancing clinical assets through clinical development, including development of second-generation processes, resupply, and late phase development as appropriate.&nbsp;&nbsp;&nbsp;The primary focus of this role will be to support late-phase tech transfer, manufacturing, and commercialization activities.&nbsp; Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing &amp; Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.&nbsp;&nbsp;&nbsp; Key Responsibilities Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.) Analyze process and manufacturing data to understand and optimize process performance&nbsp; Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations Review and approve master and executed batch records; assist with investigations Author and review internal procedures, reports, and presentations Develop process characterization and validation strategies and documentation Support regulatory activities including submissions and site inspections from preparation through execution Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.) Develop phase-appropriate product understanding and control strategies using QbD framework Create late-phase development strategy to support potential commercialization. Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization&nbsp; &nbsp; Ideal Candidate PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience 10+ years of biologics development and manufacturing experience&nbsp; Significant experience with cGMPs. Proven track record of advancing assets from pre-clinical through IND and into late phase development Experience with commercialization of biologics, including regulatory expectations for marketing approval Substantial experience leading tech transfer to CDMOs and supporting campaigns Experience with drug product development is preferred Demonstrated aptitude in collaborating cross-functionally with analytical, formulation/DP, manufacturing, and/or supply chain is required Emerging leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly&nbsp; Ability to multi-task and keep pace with a fast-moving organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Availability to participate in calls across multiple international time zones Ability and willingness to travel up to 25%, including domestic and international sites along with mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $215,000-$230,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Cell Culture Development

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary &nbsp; We are seeking a Director, Purification Development to join the TechOps team. This role will be responsible for managing CDMO(s) to develop processes that enable robust production of Drug Substance (DS) and Drug Product (DP) for protein-based biologics. This position will provide technical leadership in purification processes, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities. The role will be responsible for advancing clinical assets through clinical development, including development of second-generation processes, resupply and late-phase development as appropriate.&nbsp; The primary focus of this role will be to support late-phase tech transfer, manufacturing, and commercialization activities. Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing &amp; Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.&nbsp;&nbsp; Key Responsibilities Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.) Analyze process and manufacturing data to understand and optimize process performance&nbsp; Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations Review and approve master and executed batch records; assist with investigations Author and review internal procedures, reports, and presentations Develop process characterization and validation strategies and documentation Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.) Develop phase-appropriate product understanding and control strategies using QbD framework Create late-phase development strategy to support potential commercialization Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization&nbsp; Ideal Candidate PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience 10+ years of biologics development and manufacturing experience Significant experience with cGMPs Proven track record of advancing assets from pre-clinical through IND and into late phase development Experience with commercialization of biologics, including regulatory expectations for marketing approval Substantial experience leading tech transfer to CDMOs and supporting campaigns Experience with drug product is preferred Demonstrated aptitude in collaborating cross-functionally with analytical, formulation/DP, manufacturing, and/or supply chain is required Emerging leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly&nbsp; Ability to multi-task and keep pace with a fast-moving organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Availability to participate in calls across multiple international time zones Ability and willingness to travel up to 25%, including domestic and international sites, attendance at Apogee All Hands meetings is required, typically held twice per year&nbsp;&nbsp; The anticipated salary range for candidates for this role will be $215,000-$230,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Purification Development

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director to join the QC Analytical Sciences team in Analytical Development &amp; Quality Control to lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline. This role focuses on performing and supporting QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements. Working closely with cross-functional teams and external partners, this individual will be an important member of the TechOps team, contributing hands-on expertise to product release, stability programs, and regulatory submissions across the development pipeline, by managing multiple parallel activities at all stages of product development. Key Responsibilities Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations. Partner with global and cross-functional teams to ensure successful implementation of harmonized methods. Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements. Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues. Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines. Generate and review technical documents, including protocols, reports, and method lifecycle documents. Ideal Candidate Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field) 7+ years of analytical development &amp; quality control experience with complex biologics spanning early and late-stage development (GMP experience required) Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections Excellent communication skills with an ability to collaborate effectively across functional lines Ability to work independently and multi-task in a fast-moving organization Availability to participate in calls across multiple international time zones Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $165,000 - $185,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Quality Control – Analytical Sciences

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Director, Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization. Reporting to the VP of Formulation and Drug Product Development, this position requires deep expertise in process development, aseptic manufacturing for prefilled syringes (PFS), combination product development, and compliance, while fostering collaboration across teams and external partners. This person will be a subject matter expert in drug product manufacturing, including PFS, within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams. Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing &amp; Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.&nbsp; Key Responsibilities&nbsp; Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams Develop late-phase and commercial launch strategy for PFS development and manufacturing Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies Analyze manufacturing data and identify opportunities for process improvement and optimization Support formulation and co-formulation development for protein therapeutics, including antibodies Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.) Ideal Candidate&nbsp; Minimum of 10 years industry experience in drug product development and manufacturing 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing Demonstrated leadership in GMP manufacturing of combination products PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations Experience with process performance qualification (PPQ) and commercialization of biologics Experience with pre-approval inspection (PAI) readiness and support is preferred Experience with drug product process extractables / leachables risk assessments is preferred Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams Availability to participate in calls across international time zones Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year. &nbsp; The anticipated salary range for candidates for this role will be $210,000 to $235,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Drug Product Development

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a highly motivated and results-oriented Logistics &amp; Inventory Manager, Supply Chain Management. In this position, you will be responsible for logistics and inventory management of non-GMP &amp; GMP materials working closely with Quality, Regulatory, Manufacturing, Analytical Development, Clinical Operations and within the Supply Chain Management team. The ideal candidate will act as the primary subject matter expert for global trade compliance in Technical Operations while ensuring that material is available in the right quantities at the right time while adhering to regulatory and quality standards. The position is fully remote and reports to a senior member of the Supply Chain Management team. Key Responsibilities Oversee and execute global import and export activities in compliance with applicable trade regulations, including management of licenses, permits, and country-specific requirements. Act as Importer of Record (IoR) when required, ensuring full compliance with statutory obligations and recordkeeping requirements. Ensure internal procedures and broker practices remain aligned with evolving regulatory requirements. Prepare, review, and maintain shipping documentation, ensuring inspection-ready archiving and recordkeeping. Manage domestic and international logistics for cell banks, drug substance (DS), drug product (DP), and devices, ensuring timely and compliant delivery across the global clinical supply network. Ensure real-time shipment visibility and timely resolution of logistics deviations, including delays, temperature excursions, and customs issues. Establish, qualify, and maintain compliant logistics lanes, shipment models, and escalation pathways. Build and manage a network of freight forwarders, couriers, and customs brokers, including sourcing, evaluation, selection, onboarding, and performance management. Oversee GMP and Non-GMP inventory management, including tracking, reconciliation, and control across CMOs, depots, laboratories or other required sites. Establish and oversee periodic inventory verification and review activities to ensure inventory accuracy, compliance and destruction as appropriate. Investigate and resolve inventory discrepancies in partnership with Quality, CMOs, and internal partners. Ensure logistics and inventory activities comply with GMP, GDP, GxP, and internal SOPs; support audits and regulatory inspections. Partner with Quality on deviation investigations, root cause analysis, and CAPA implementation related to logistics, inventory, or trade compliance. Perform Clinical Supply Chain activities, such as, but not limited to, study level forecasting and planning, packaging and labeling and/or finished goods distribution. Develop and maintain SOPs, work instructions and reporting to support operational excellence and scalability. Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance Ideal Candidate S/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in clinical supply chain logistics and inventory management Hands-on experience with international import/export controls and trade compliance Experience acting as Importer of Record (IoR) required Licensed Customs Broker (LCB) certification strongly preferred VAT recovery and tariff knowledge is preferred Demonstrated experience managing GMP and Non-GMP materials and temperature-controlled supply chains Experience with ERP, IRT, Forecasting tools or inventory management systems Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP) Proven ability to manage multiple projects, proactively identify and resolve issues using strong attention to detail and problem-solving skills Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity Excellent communication and influencing skills, strong collaboration skills Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Strong knowledge of Microsoft Office, including Excel, Word and PowerPoint Smartsheet experience is strongly preferred. PowerBI, experienced excel (macros) and/or Tableau is a plus Position requires up to 25% travel (domestic and international) including mandatory in-person attendance at All Hands meetings typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $145,000 to $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Logistics & Inventory Manager, Supply Chain Management

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a highly experienced and motivated individual to lead our biomarker efforts in the field of inflammatory and immune diseases, with a focus on atopic dermatitis, asthma, COPD and EOE. Reporting to the Senior Vice President – Research and Translational Medicine, the successful candidate will be responsible for overseeing the strategy and implementation of all our translational clinical and preclinical biomarker programs from early but particularly late-stage development including Phase&nbsp;3 trials and BLA-readiness for all our assets. As Vice President – Inflammatory and Immune Disease Biomarker Development you will be leading and growing our internal team as well as our network of external vendors and collaborators. If you are a driven and innovative senior leader with a passion for biomarker development in I&amp;I diseases as well as a deep late-stage clinical development understanding, we encourage you to apply for this exciting opportunity to make a meaningful impact on the lives of patients. Key Responsibilities Lead the strategic planning and execution of biomarker discovery and development programs for inflammatory and immunology diseases, focusing on atopic dermatitis, asthma, COPD and EOE and particularly late-stage clinical development Develop and articulate the late-stage clinical and post-launch strategic vision for the biomarker programs to internal and external stakeholders Collaborate with internal and external stakeholders to integrate our biomarker discovery and development efforts into our development programs, including clinical trials and BLAs Oversee the Biomarker Discovery and Development team to drive efforts through a combination of in vitro/in vivo and in silico data analyses, in house and in collaboration with external partners Together with the Senior Director-Biomarker Discovery and Development develop and implement biomarker strategies to demonstrate the clinical utility of novel biomarkers and the distinction of patient populations and responders as well as additional indications Stay current on emerging trends and technologies in biomarker discovery and development, and implement best practices to ensure the success of our programs Provide strategic input and leadership to cross-functional program and functional teams to drive the development of novel, innovative therapies for inflammatory and immunology diseases Ideal Candidate PhD or MD in a relevant scientific discipline with at least 15 years of track-record in senior leadership roles in biomarker discovery and development, preferably in the field of inflammatory and immunology diseases Proven success in leading biomarker discovery programs from ideation to clinical validation and a focused understanding on late-stage clinical development including Phase&nbsp;3 trials with biologics and BLAs is required. Experience in I&amp;I, atopic dermatitis, asthma, COPD and/or EOE a plus Excellent communication skills and ability to articulate and communicate complex strategic vision with a variety of internal and external stakeholders Deep hands-on knowledge of the antibody development process and regulatory requirements for biomarkers in clinical trials and for BLA-submissions. Strong preference for candidates with late stage clinical and post launch experience Expertise in collaborating with external partners and key opinion leaders in the field of inflammatory and immunology diseases Strong leadership and communication skills fully aligned with our C.O.R.E. values, with the ability to effectively lead your internal team and fully integrate this team from early- to late-stage clinical development efforts Position requires up to 30% travel including mandatory in-person attendance at All Hands meetings typically held twice per year as well as travel to Apogee offices in Boston and San Francisco. The anticipated salary range for candidates for this role will be $320,000-$355,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Vice President, Inflammatory and Immune Disease Biomarker Development

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, Clinical Operations who will be accountable for the operational management and execution of clinical trial programs (Phases II-III and later). The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The Associate Director, Clinical Operations will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. This role will report to the Executive/Sr. Director, Clinical Operations. Key Responsibilities Accountable for overall management of multiple clinical trials Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs Responsible for preparing and/or presenting to executive management as delegated Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings Budget/Finance/Legal Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc Review and approve contracts, work orders and invoices prior to submission to senior management for approval Outsourcing/Procurement/Vendor Management Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals Draft and/or manage Governance charters/meetings/reports with CRO Co-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, completion of Trial Master File and the following: Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO Responsible for patient recruitment and retention plans Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB/Ethics submission prior to study start-up Clinical and Ancillary Study Supplies In conjunction with Clinical Supply, responsible for assuring sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study&nbsp; Responsible for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study In conjunction with CRO, responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.) Inspection Readiness Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files Partner with Quality organization to document Sponsor Oversight of all vendors, Data Integrity, and Risk Assessment requirements Participates and responds to Quality Assurance and/or regulatory authority inspection audits Ensures all assigned studies are always Inspection Ready Data Review/Cleaning/Management Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality.&nbsp; Oversight includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Oversight of protocol deviations/variations In conjunction with the CRO, oversee and drive the metrics on CRA source data verification Ideal Candidate BA/BS in life sciences or equivalent&nbsp; 8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion 2+ years’ experience in Biotech industry strongly preferred Significant knowledge of pharmaceutical industry, drug development and regulatory processes Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines Work comfortably in a fast-paced, dynamic work environment and embrace change Position requires up to 15% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $180,000 - $195,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Operations

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Document Control Specialist who will manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite), related to Phase III and Commercial readiness associated GXP (i.e., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)) documentation. The successful candidate will play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance and will support cross functional teams’ success in the advancement through every stage within the document lifecycle. This position will report to the Associate Director, Quality Systems. &nbsp; Key Responsibilities Document Control: Maintain document control policies, procedures, and systems in accordance with GXP regulations. Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training. Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records. Quality Assurance: Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.” Maintain robust quality control measures for all GXP documents. Veeva Expertise: Leverage experience with Veeva Systems to optimize document management processes and workflows. Provide guidance and training to staff on using Veeva for document control and compliance purposes. Regulatory Compliance: Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH). Cross-functional Collaboration: Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance. Continuous Improvement: Identify opportunities for improvements in GXP document and record control practices. &nbsp; Ideal Candidate Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences). Minimum of 3-5 years’ Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry, with 1-2 years’ direct experience within Veeva Quality Vault. Working knowledge of electronic document management systems; Veeva Quality Vault required. General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems. Strong attention to detail and a commitment to maintaining accuracy and compliance required. Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet. Exceptional organizational, communication, and problem-solving skills. Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects. Ability to collaborate and work effectively with cross-functional teams. Familiarity of GXP regulatory requirements and quality standards. Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless. Ability and willingness to travel up to 10% (approximately 3-6 times per year for company meetings). The anticipated salary range for candidates for this role will be $85,000 - $100,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

QA Document Control Specialist

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary The Department of Research and Translational Medicine is seeking a Sr. Manager, Clinical Biomarker Operations. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management. Key Responsibilities Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition. Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications. Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions. Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance. Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships. Support QA in vendor audit and inspection activities. Support activities related to biomarker budget planning and tracking of accruals. Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards. Continuously identify and build best practices for process improvements. Ensure high quality data generation by overseeing sample integrity and external collaborations. Ideal Candidate&nbsp; MS or higher with &gt; 3 years or BS with &gt;5 years of direct experience in biomarker operations role. Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage. Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities. Experienced in all phases of clinical trials, Phase 3 experience is an asset. Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general. High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines. Experience in I&amp;I indications. Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines. Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops. The anticipated salary range for candidates for this role will be $160,000 - $175,000 / year. &nbsp;The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Clinical Biomarker Operations

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We seek an&nbsp;experienced biotech&nbsp;project manager to&nbsp;optimize&nbsp;planning, execution, and&nbsp;tracking for&nbsp;development-stage programs. This role is focused on implementing robust PM processes and building effective tools and systems, especially leveraging Smartsheet for process improvement and project management.&nbsp;You’ll&nbsp;support&nbsp;optimization of&nbsp;project plans, schedules, stakeholder communications, and&nbsp;Smartsheet&nbsp;operations. The role involves managing timelines, resources, and risks, while developing&nbsp;expertise&nbsp;in drug development and project management. &nbsp; Key Responsibilities&nbsp; Support evaluation, implementation, and use of project management tools (especially Smartsheet); define methodologies and reporting frameworks Develop and maintain integrated program timelines across multiple projects Create and manage templates, dashboards, and visual reports for teams and leadership Facilitate meetings, schedule attendees, and capture minutes Build custom PMO solutions: perform gap analyses and develop strategic recommendations Design and maintain Smartsheet sheets, reports, dashboards, and forms Implement Smartsheet workflows and automations, coordinate improvements with stakeholders Provide executive- and task-level project reporting Track risk, quality, and performance metrics Troubleshoot and enhance PMO solutions, support system updates and new capabilities Demonstrate critical thinking and initiative to improve PM practices &nbsp; Ideal Candidate&nbsp; Bachelor’s degree in life sciences, pharmacy, chemistry, or related field Minimum 5 years total work experience with 2 years of project management experience in biotech or pharma, preferably with cross-functional teams At least 2 years’ hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro, MS Project, OnePager) Experience with Smartsheet premium apps such as Control Center, Data Shuttle, Dynamic View, Resource Management&nbsp;preferred PMP or CAPM certification&nbsp;preferred Knowledge of biotech processes, scientific terminology, and drug development concepts Proactive and structured approach to problem-solving, able to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions Strong organizational, communication, and problem-solving skills Ability to work independently, manage multiple priorities, and thrive in a dynamic environment Team player that contributes valuable ideas and feedback and can be counted on to meet commitments Attentive to detail, team player, adaptable and has continuous improvement mindset Willingness to travel up to 2 times per quarter, including frequent trips to Apogee offices in San Francisco and/or Boston &nbsp; The anticipated salary range for candidates for this role will be $145,000-$175,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Manager, Program Management (PMO)

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (CQA) to join our team. This key role will report to the Head of Clinical Quality Assurance and is responsible for assisting with the establishment of a robust QA system for our clinical operations. In this role, you will ensure compliance with regulatory standards and promote a culture of quality throughout the organization.&nbsp; Key Responsibilities Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision Act as CQA lead representative at clinical study team meetings and other study related meetings Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization Assist in the development and/or delivery of GCP training topics and quality standards as directed Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals Collaborate with clinical functions to support inspection readiness activities Perform key activities during regulatory authority inspection and/or external audits as directed by Head of CQA Ideal Candidate Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus 8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function Minimum of 6 years of direct audit experience in GCP In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change Excellent problem-solving and critical thinking abilities Flexible and creative to meet the needs and challenges of a growing, dynamic company Focus on fostering a culture of collaboration and teamwork Ability to manage multiple projects with aggressive timelines and changing priorities Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $170,000-$190,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Quality Assurance

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Executive Director, Global Clinical Operations, (GCO), who will be accountable for the strategic operational management, tactical planning, and execution of global clinical trial programs (Phases II-III). In this role you will be a key leader within Clinical Operations, driving the success of your assigned clinical trials and teams. In collaboration with leaders across the organization you will provide clinical operations expertise to a cross-functional matrix team. This position is fully remote and reports to the VP, Clinical Trial Operations (CTO). Key Responsibilities Clinical Operations Leadership Manage and plan CTO resourcing for assigned programs Lead, build and mentor CTO team supporting assigned program(s) Serve as a member on Clinical Operations Leadership Team (COLT) Create and support implementation of Clinical Operations processes, platforms and/or systems Cross Functional Leadership Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs Clinical operations representative on Program Teams (PT) Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy Strong collaboration and partnership with cross functional colleagues globally (e.g., Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc.) to ensure on-budget, timely, high-quality delivery of the programs Accountable for overall management of clinical trials Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements across the assigned clinical program(s) Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols Ensure accurate tracking/reporting (dashboard) of study metrics and progress of study through completion Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs Develop, review and/or consult on clinical trial documents, such as informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings Budget/Finance/Legal Accountable for program level clinical operations budget forecasting, accrual management and quarterly review, ensuring tight control between study forecasts and actuals In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc Review and approve contracts, work orders and invoices prior to submission to Executive approval Outsourcing/Procurement/Vendor Management Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) in partnership with Clinical Business Operations Demonstrate consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others, as necessary, to assure alignment and achievement of study goals Draft and/or manage Governance charters/meetings/reports with CRO Responsible for managing relationships with CROs and other vendors for all study activities, including study start-up, close out, completion of Trial Master File and the following: Setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations Negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO Patient recruitment and retention plans Set-up of all third-party vendor specifications (i.e., IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB//Ethics submission prior to study start-up Clinical and Ancillary Study Supplies Collaborate with Clinical Supply to &nbsp;assure sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study In conjunction with CRO, accountable for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study In conjunction with CRO, accountable for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.) Inspection Readiness Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Oversees routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files Partner with Quality organization to document Sponsor Oversight of all vendors, data integrity, and risk assessment requirements Participate and respond to Quality Assurance and/or regulatory authority inspection audits Ensure all assigned protocols are always inspection ready Data Review/Cleaning/Management Accountable for working closely with Biometrics, Pharmacovigilance and the CRO to oversee data cleaning and review, and oversee adherence to study timelines and data quality. In conjunction with the CRO, oversee and drive the metrics on CRA source data verification Ideal Candidate BA/BS in life sciences or equivalent Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion, coupled with demonstrated ability to hold team and CRO members accountable to tight timelines and budgets Minimum of 7 years line management experience Minimum of 3 years’ experience in Biotech industry strongly preferred Significant knowledge of pharmaceutical industry, drug development and regulatory processes Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc. Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety. Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally. Proven ability to effectively execute clinical trials within designated program budgets, timelines and compliance guidelines Experience on governance committees and management teams for CROs or other vendors Strong negotiation and conflict resolution skills Strong financial acumen and ability to critically develop, review and track program budgets Must be comfortable working in a fast-paced work environment,&nbsp; able to organize, prioritize, and&nbsp; effectively respond to&nbsp; changing priorities Position requires approximately 30% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, may also require travel to phase 3 planning meetings held in San Francisco The anticipated salary range for candidates for this role will be $285,000-$320,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Executive Director, Global Clinical Operations

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, QC Manufacturing Support to provide GMP raw materials testing program management and to additionally support drug substance process-related analytical testing activities as a liaison to Apogee’s DS, DP, and MSAT teams. The ideal candidate has deep technical expertise and understanding of GMP raw materials QC testing management and regulatory expectations, is competent and experienced operating in GMP quality management systems and has experience with analytical in-process testing for biologics (e.g., protein concentration, titer, etc.). Responsibilities may include: Author internal raw materials testing specifications, specifically for non-compendial raw materials Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing Preferred Qualifications: BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.) 10+ years of biotech industry experience in QC operations or analytical support roles with at least 6 years demonstrated experience supporting a GMP raw materials testing program Understanding of analytical techniques relevant to monoclonal antibody testing Experience in relationship management with external analytical test sites Ability to effectively prioritize and manage multiple projects Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing Excellent communication skills; able to collaborate effectively across multidisciplinary teams Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless The anticipated salary range for candidates for this role will be $160,000-$180,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, QC Manufacturing Support

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a dynamic and experienced Associate Director of IT Infrastructure Operations to join our fast-growing, energetic, and cloud-first biotechnology company. The ideal candidate will be a results-oriented thinker with technical experience and a focus on collaboration, customer service, user experience, and the effective support of business goals. This role requires an individual who can guide projects to completion with quality and efficiency in coordination with our MSP, while also contributing directly with strong technical skills. In this newly created position, you will have the opportunity to build and grow our infrastructure operations through robust cloud solutions that support Apogee's growth and scientific breakthroughs while fostering a culture of excellence and innovation within our team. Key Responsibilities Propel effective delivery of IT Infrastructure services like Microsoft Entra, Intune, M365/Teams, Azure, Smartsheet, Zoom, IAM, and disaster recovery, through both your own technical ability and through working with others. Foster a collaborative and customer-service-focused culture within the team and with our MSP-based Helpdesk and SOC teams. Work closely with IT peers as well as business teams to understand their needs and develop solutions that support business goals. Facilitate communication and collaboration between IT and other teams. Ensure exceptional customer service and user experience by implementing best practices and continuous improvement processes. Address and resolve Infrastructure issues promptly and effectively. Design and implement solutions that enhance user experience and meet the evolving needs of the company. Continuously monitor and improve IT systems to ensure optimal performance. Provide strong project management leadership, prioritizing tasks and managing resources effectively to meet deadlines and objectives. Steer IT infrastructure projects from inception to completion, ensuring they are delivered on time, within scope, and with high quality. Utilize project management methodologies to manage resources and timelines. Build knowledge of how our business and industry operate, to build and deliver Infrastructure solutions that maximally boost company effectiveness. Partner with IT team members to execute the organization’s technology strategy, aligned with company goals, the biotech industry's best practices, and regulatory requirements. Stay informed of industry trends and emerging technologies to ensure the company's IT infrastructure remains competitive and innovative. Manage relationships with external vendors and service providers, ensuring they deliver high-quality services and support. Negotiate contracts and agreements to achieve the best value for the company. Ensure the delivery of superior results within the terms of various SOWs. Manage requirements and expectations within project constraints. Ideal Candidate Bachelor’s degree in Information Technology, Computer Science, or a related field Extensive knowledge of IT Infrastructure, such as Azure, Okta, M365, and IAM, with hands-on experience in implementing, architecting, and managing infrastructure operations and services A minimum of 7 years of IT Infrastructure experience, including working across teams and vendors Proven experience in working with MSP-based support teams, driving efficiency, business results, and high user satisfaction Experience in a high-growth biotech or pharmaceutical company environment Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally Proven ability to effectively execute IT projects within designated program budgets, timelines, and compliance guidelines Excellent communication skills with an ability to present to a variety of stakeholders, and tailor the message accordingly Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless Relevant certifications are a plus Ability and willingness to travel appropriately 10 – 15% The anticipated salary range for candidates for this role will be $160,000-$185,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, IT Infrastructure Operations

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced biotech industry contract specialist to provide general corporate, public company and contracts administration support to the Legal Department and to provide other services as required. In this role, you will work across functions and teams as a trusted partner to proactively facilitate the efficient negotiation, execution and tracking of contracts with a focus on client service, professionalism, confidentiality, superior organizational and prioritization skills, as well as a high level of attention to detail. Key Responsibilities Partner with Legal Department members to assist with the drafting, negotiation and management of a high volume of contracts for clinical, research, quality, manufacturing, commercial and other internal business partners, including clinical trial agreements, master services agreements, consulting agreements, confidentiality agreements, research agreements and other business agreements Act as a liaison between internal business partners, the Legal Department, external vendors and outside counsel as necessary to facilitate contract implementation, renewals, and terminations Continue to improve the internal contracting process, including assisting with the administration of our integrated contracts management system, developing internal training materials related to the contracting process and identifying steps to increase efficiency Help develop and implement new policies, procedures and contract templates and provide related education and training to internal clients Work closely with members of finance and other departments to help ensure compliance with cross-functional policies and procedures Develop reports, presentations, spreadsheets, memos and other documents for the Legal Department, internal clients and/or the senior management team Review clinical study informed consent forms and related documents as needed Assist with completion, review and validation of needs assessment forms in connection with HCP engagements, including to confirm alignment with fair market value and contractual terms Identify legal, documentation gaps and contractual risks and escalate matters in accordance with protocols and guidance Provide practical contracts support to internal clients during contract preparation and negotiation Complete special projects as requested, such as conducting research and collaborating on department-wide or company-wide initiatives Ideal Candidate Bachelor’s degree, or an equivalent amount of relevant industry experience in a legal or related field, is required 6+ years of experience in the life sciences industry drafting and negotiating a variety of contracts Public company experience required Prior in-house experience as a member of a Legal Department or clinical affairs department in a biotechnology or pharmaceutical company drafting and negotiating clinical trial agreements strongly preferred Experience with confidentiality agreements, master services agreements, consulting agreements, clinical trial agreements, GCP guidelines and regulatory requirements for global clinical trials Exceptional contract drafting and negotiation skills Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization Excellent professionalism and interpersonal skills; ability to handle confidential and proprietary information using sound judgement and discretion Experience with contract management systems and electronic signature systems and high proficiency in Microsoft Office applications required; experience with Agiloft is a plus Must possess outstanding attention to detail and organizational skills Ability to work independently and collaboratively within a remote virtual environment Ability to keep pace in a fast-moving organization and navigate ambiguity Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $165,000-$185,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Contracts

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced biotech industry Associate Director, Contracts to provide general corporate, public company and contracts administration support to the Legal Department and to provide other services as required. In this role, you will work across functions and teams as a trusted partner to proactively facilitate the efficient negotiation, execution and tracking of contracts with a focus on client service, professionalism, confidentiality, superior organizational and prioritization skills, as well as a high level of attention to detail. Key Responsibilities Partner with Legal Department members to assist with the drafting, negotiation and management of a high volume of contracts for G&amp;A functions and commercial, research, clinical, quality and manufacturing and other internal business partners, including master services agreements, consulting agreements, confidentiality agreements, research agreements and other business agreements Act as a liaison between internal business partners, the Legal Department, external vendors and outside counsel as necessary to facilitate contract implementation, renewals, and terminations Continue to improve the internal contracting process, including assisting with the administration of our integrated contracts management system and identifying steps to increase efficiency Help develop and implement new policies, procedures and contract templates and provide related education and training to internal clients Assist with completion, review and validation of needs assessment forms in connection with HCP engagements, including to confirm alignment with fair market value and contractual terms Work closely with members of finance and other departments to help ensure compliance with cross-functional policies and procedures Develop reports, presentations, spreadsheets, memos and other documents for the Legal Department, internal clients and/or the senior management team Review clinical study related documents, as needed Identify legal, documentation gaps and contractual risks and escalate matters in accordance with protocols and guidance Provide practical contracts support to internal clients during contract preparation and negotiation Conduct research as needed Complete special projects as requested, such as collaborating on department-wide or company-wide initiatives Ideal Candidate Bachelor's degree 7+ years of experience in the life sciences industry drafting and negotiating a variety of contracts Public company experience required Prior in-house experience as a member of a Legal Department in a high-growth biotechnology or pharmaceutical company drafting and negotiating a range of contracts is required Experience with confidentiality agreements, master services agreements, consulting agreements, clinical trial agreements, GCP guidelines and regulatory requirements for global clinical trials Exceptional contract drafting and negotiation skills Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization Excellent professionalism and interpersonal skills; ability to handle confidential and proprietary information using sound judgement and discretion Experience with contract management systems and electronic signature systems and high proficiency in Microsoft Office applications required; experience with Agiloft is a plus Outstanding attention to detail and organizational skills are a must Ability to work independently and collaboratively within a remote virtual environment Ability to keep pace in a fast-moving organization and navigate ambiguity Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15%&nbsp;travel, including in-person mandatory attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $165,000 - $185,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

&nbsp; About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics,&nbsp;Inc.&nbsp;is a biotechnology company&nbsp;seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.&nbsp;Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.&nbsp;We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.&nbsp; If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Business Development &amp; Strategy. As a member of the Business Development &amp; Strategy team, you will be responsible for compiling and synthesizing competitive intelligence and using those insights to help shape our corporate strategy. In addition, you will be responsible for working cross-functionally to support Apogee’s programs and other business objectives. Contributing to business development efforts, this person will also execute strategic, scientific, and clinical analyses to support Apogee’s partnering objectives. This role will report to the Executive Director of Business Development &amp; Strategy and will interface frequently with members of the Executive Team. Key Responsibilities Track, analyze, and interpret competitive developments relevant to Apogee’s programs Attend key scientific and medical conferences Collaborate with other functions to support Apogee’s programs and business objectives Support the Executive Team to help develop and communicate the corporate strategy Execute strategic analyses on behalf of the Executive Team and Board of Directors Identify and conduct due diligence on new targets and in-licensing opportunities Support business development and partnering discussions Ideal Candidate BS/BA degree in a scientific field or related discipline with Ph.D., MD, MD/PhD, or PharmD preferred 2+ years’ experience in professional services with a demonstrated focus on healthcare and/or life sciences (e.g., management consulting, equity research, investment banking, venture capital) Excellent communication skills with an ability to present to a variety of stakeholders including both technical and non-technical audiences (e.g., executives, scientists, clinicians) and tailor message accordingly Highly collaborative with the ability to work cross-functionally with teams across the organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Clinical and scientific aptitude Familiarity with the drug development process Experience in inflammatory &amp; immunological therapeutic areas preferred Position requires 15% - 20% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. This position may also require US and international travel to medical conferences. The anticipated salary range for candidates for this role will be $180,000-$195,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp;&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Business Development & Strategy

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Head of Strategic Sourcing &amp; Procurement. In this newly created position, you will lead Apogee’s strategic sourcing and procurement function as we continue to grow into a later stage clinical development and potentially commercial biotechnology company. Reporting to the SVP of Finance, you will have the opportunity to establish this critical function and build it as the company grows. A key component of this role is to build and manage long-term, mutually beneficial vendor relationships that drive value and support the company's mission to improve treatment options for patients living with I&amp;I conditions. Additionally, you will act as a strategic partner with functional business partners across the company, in particular clinical development, clinical operations, manufacturing, and legal and other SG&amp;A functions to work on supplier selection and developing and negotiating contracts and enforcing terms. Key Responsibilities: Develop and implement an enterprise-wide strategic sourcing and procurement framework that encompasses best in class processes for vendor sourcing, selection, qualification, risk assessment, onboarding, performance management, and lifecycle governance, ensuring alignment with business objectives, regulatory requirements, and quality standards Develop and implement end-to-end procurement strategies and processes, including aligning procurement activities with the overall business goals and objectives Oversee procurement operations, ensure efficiency, cost-effectiveness, and compliance with company policies and regulations and ensure that all procurement activities are conducted efficiently and effectively, from requisition to payment Manage the RFPs/RFQs/RFIs process, review materials in partnership with business stakeholders and legal Negotiate contracts to secure favorable terms and conditions for the company in partnership with functional business partners and legal Identify, evaluate, and select partners that are qualified to meet Apogee’s needs in terms of cost, quality, delivery, and innovation Develop criteria for and manage Apogee’s preferred vendor list Conduct spend analysis across functional areas to gain a comprehensive understanding of spending patterns, supplier performance, and potential cost-saving opportunities Build and maintain strong relationships with key suppliers, fostering collaboration and ensuring quality and reliability, manage performance and taking corrective action when necessary Monitor and analyze procurement performance, track key performance indicators (KPIs) to identify areas for improvement and drive continuous improvement Ensure that all procurement activities are conducted within functional budget constraints Ensure compliance with all relevant laws, regulations, and company policies Stay informed about the latest trends and technologies in the strategic sourcing and procurement industry and share knowledge across the company Ideal candidate &nbsp; Minimum of 15 years of relevant experience; minimum of 8 years leading a strategic sourcing and procurement function in the pharmaceutical/biotech industry Bachelor's degree required, advanced degree preferred Experience leading and building strategic sourcing and procurement capabilities in a high growth clinical development environment required, commercial experience preferred Solid understanding of the overall drug development process with an emphasis on clinical trials, CRO vendor management, clinical supply chain and commercial manufacturing Ability to lead cross functional teams and develop strong partnerships internally and externally Deep understanding of contract terms, provisions, and their impacts to the business; extensive experience negotiating complex agreements across all functions Can manage multiple programs/projects, sound organizational and time management skills Ability to develop concise presentations to convey complex issues at all levels including senior management, board of directors and key stakeholders Ability to adapt and effectively problem solve through partnering with stakeholders in a constructive manner, and operate in a fast-paced environment This position requires up to 20% domestic and/or international travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $275,000 - $295,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Head of Strategic Sourcing & Procurement

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Document Control Specialist who will manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite), related to Phase III and Commercial readiness associated GXP (i.e., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)) documentation. The successful candidate will play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance and will support cross functional teams’ success in the advancement through every stage within the document lifecycle. This position will report to the Associate Director, Quality Systems. &nbsp; Key Responsibilities Document Control: Maintain document control policies, procedures, and systems in accordance with GXP regulations. Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training. Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records. Quality Assurance: Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.” Maintain robust quality control measures for all GXP documents. Veeva Expertise: Leverage experience with Veeva Systems to optimize document management processes and workflows. Provide guidance and training to staff on using Veeva for document control and compliance purposes. Regulatory Compliance: Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH). Cross-functional Collaboration: Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance. Continuous Improvement: Identify opportunities for improvements in GXP document and record control practices. &nbsp; Ideal Candidate Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences). Minimum of 3-5 years’ Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry, with 1-2 years’ direct experience within Veeva Quality Vault. Working knowledge of electronic document management systems; Veeva Quality Vault required. General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems. Strong attention to detail and a commitment to maintaining accuracy and compliance required. Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet. Exceptional organizational, communication, and problem-solving skills. Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects. Ability to collaborate and work effectively with cross-functional teams. Familiarity of GXP regulatory requirements and quality standards. Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless. Ability and willingness to travel up to 10% (approximately 3-6 times per year for company meetings). The anticipated salary range for candidates for this role will be $85,000 - $100,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of TMF (Trial Master File) Management. This position is responsible for the oversight, planning, resourcing, and execution of end-to-end TMF management processes from start up through archival and for ensuring optimal health of TMF content from both external and internal sources. In this role you will provide technical and operational leadership, strategic direction, and ensure continuous inspection readiness. You will apply cross-functional collaboration to drive change management, promotion adoption of enhanced processes and standards, foster a culture of continuous improvement, and ensure proper implementation, execution, and alignment with companies’ goals, culture, and vision. Additionally, you will &nbsp;assist with developing and implementing TMF processes, SOPs, supporting tools, templates, and training. You will have the opportunity to lead a team who manage the TMF for studies in the program. This position will oversee TMF vendors and work with the IT group to support implementation, ongoing maintenance, and configuration changes of the eTMF platform in alignment with the business requirements. Key Responsibilities Provide leadership and act as a Subject Matter Expert (SME) for TMF operations and requirements across study team functions, CROs, and vendors to ensure TMF content is timely, complete, and of the highest quality for in-house and outsourced studies Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner Serve as an escalation point for study teams to drive resolution of issues, as appropriate Ensure compliance with TMF Management SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring &amp; Available), applicable regulations, GCP requirements, and industry standards Monitor and report KPIs to senior management, identifying trends across the portfolio, areas for improvement, and implementing changes as needed Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required Responsible for the management and leadership of a team of direct reports that will support the eTMF platforms and each study TMF including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback Assist with development and implementation of TMF processes, procedures, supporting tools, and TMF-related training materials that adhere to regulatory requirements and industry best practices Review external TMF-related SOPs and associated documentation as needed Author and review TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.), working with the cross functional study team to obtain necessary input Oversee study teams in TMF closeout activities, including collection of study records from all vendors, end of trial TMF QC, and migration activities, if applicable Oversee archiving activities to ensure adherence to processes and industry best practices Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with start-up activities, record collection and processing, QC, and/or archiving, as needed Collaborate on projects with Information Technology (IT) to ensure effective implementation and integration of eTMF clinical systems Lead and manage resolution of issues and remediation activities with stakeholders and the eTMF vendor Serve as eTMF Business Owner and Administrator Support integration of partnered or clinical information including TMF transfers in compliance with applicable regulations and best practice Provide eTMF system training and acts as a primary support for users and study teams Assist management with identifying areas of improvement and enhancements and obtains approval for system development projects Ideal Candidate Bachelor's Degree or higher 10+ years of experience successfully leading the TMF activities for clinical research/ biotech/pharmaceutical Experience with Veeva Vault eTMF platform, strongly preferred Experience with implementation and integration of eTMF platforms Experience with computer system validation/assurance Experience in managing direct reports and leading teams to execute projects Knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/ biotech or contract research organization industry Comprehensive knowledge of TMF Reference Model, regulations, Good Clinical Practices (GCP), and ICH Guidelines Strong software and computer skills, including Microsoft Office applications (Outlook, Word, Excel &amp; PowerPoint) Relevant experience in processing, archiving, and retrieving records in electronic format Experience with writing and revising SOPs related to eTMF systems Knowledge of relevant licensing and industry compliance regulations This role necessitates self-direction, motivation, problem solving and decision-making abilities Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership Able to lead initiatives and communicate effectively through presentations for external and internal audiences Excellent organizational skills with outstanding attention to detail and follow through Able to successfully manage/prioritize multiple projects with limited direction from manager Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations &nbsp;&nbsp; Able to collaborate with the vendor on on-going system issues, upgrades, and maintenance Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory in-person attendance at All Hands Meetings typically held twice per year The anticipated salary range for candidates for this role will be $170,000 - $185,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, TMF Management

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking a Senior Manager, Scientific Communications &amp; Medical Operations Reporting to the Executive Director, Scientific Communications, the successful candidate will support operational and planning aspects of medical congress and publication activities. This role focuses on operational coordination, process management, and cross-functional collaboration to ensure scientific communication deliverables, including publications and congress materials/activities are executed compliantly. Key Responsibilities Partner with Scientific Communications, Medical Affairs, and cross-functional stakeholders to track and ensure timely delivery of congress activities across medical affairs. Proactively manage timelines and status trackers for medical congress activities and maintain accurate and up-to-date congress and publication plans. Manage and administrate standard systems for review and tracking of publications and medical materials, including routing and trackingreview and running reports. Operational execution of congress activities, including booth scheduling, vendor coordination, metrics and asset tracking, badge procurement, and meeting registration. Ideal Candidate Bachelor’s degree in life sciences or a related field. 5+ years of experience in medical communications, scientific communications operations, or congress planning within biotechnology, pharmaceutical, or a medical communications agency. Strong project management skills, including attention to detail, organization, and the ability to manage multiple projects efficiently in a regulated environment. Knowledge of the Medical, Legal, and Regulatory (MLR) review process for non-promotional scientific or medical materials. Hands-on experience with medical communications review systems. Working knowledge of publications review processes and experience supporting a publications management system. Familiarity with ISMPP guidelines and best practices for ethical publication development and disclosure. Experience with publication process requirements in pharma, including documentation and review and approval processes. Strong skills in presentation and spreadsheet software (e.g., PowerPoint, Excel) and experience with collaborative content management platforms (e.g., SharePoint) and workflow/project management tools (e.g., Smartsheet). Clear, professional communication skills and ability to work effectively with cross-functional partners, external authors, and vendors. Position requires up to 10% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Nice to Have Masters Degree or MBA Experience with PowerBI, Microsoft Timelines, and/or Adobe Design Suite CMPP (Certified Medical Publication Professional) credential The anticipated salary range for candidates for this role will be $155,000-175,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Scientific Communications, Planning & Operations

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking an Associate Director, Data Management to impact multiple high impact programs at Apogee Therapeutics. In this position you will be responsible for both management and technical aspects of the Data Management elements of clinical trials. You will manage the direction, planning, execution, and interpretation of all the data management activities related to clinical trials/research (Phase I-IV). &nbsp; Key Responsibilities Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks Work closely with CROs to prepare and ensure proper development and execution of data management activities Review protocols to ensure database feasibility Provide effective oversight of all CRO data management related deliverables Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion. Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is in an audit-ready state Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.) Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements &nbsp; Ideal Candidate Bachelor’s Degree in health-related field Minimum of 8 years of clinical data management in pharma/biotech/healthcare industry Must be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studies Technology proficiency including Data Management Systems. Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality Extensive experience managing CROs and other data vendors Submission experience (NDA, sNDA and BLAs) Knowledge of Good Clinical Practice EDC and eCOA experience (Medidata, Veeva, etc.) Excellent written and oral communication Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment Ability to keep pace in a fast-moving organization and navigate ambiguity Experience working with in a remote virtual environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. &nbsp; The anticipated salary range for candidates for this role will be $180,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Data Management

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity. &nbsp;Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites. The Clinical Monitoring Manager collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives. Key Responsibilities In-house responsibilities The Clinical Monitoring Manager is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements May be responsible for the hiring of in-house CRAs Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms) Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plans, site visit report templates, monitoring tools) Support the training and development of in-house CRAs and ensuring study training compliance is maintained Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed Responsible for oversight of CRA review of clinical data (e.g., electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations Support and liaise with clinical site personnel, as needed Review and approve time sheets and expense reports Assist with review and revision of departmental SOPs and policies Assist with creation and delivery of new department initiatives, improvement plans or training May assist with the identification and selection of appropriate clinical trial sites and investigators Field monitoring responsibilities Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines Review and ensure data integrity, accuracy, and completeness at the clinical study sites Escalate site related issues to the study team Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed Ideal Candidate Bachelor's degree in a scientific or healthcare-related field Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry Minimum 2 years of experience leading a team of CRAs Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus Certification as a Clinical Research Associate (CCRA) or equivalent preferred Recent experience working on trials utilizing risk-based monitoring models Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems Strong understanding of clinical trial processes and study conduct Excellent organizational and time management skills Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight Experience working in a fast-paced and dynamic environment Successfully exhibit Apogee’s&nbsp;C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $150,000 - $170,000. per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Senior Financial Analyst in FP&amp;A. In this role, you will be an integral member of the Finance team as we continue to build and enhance our FP&amp;A capabilities. This position understands the business well, is highly analytical, and provides financial and strategic insights to enable the company to make well-informed decisions. This position requires the ability to effectively partner, communicate, and collaborate across the Finance team and with various levels of management and program/functional teams across the company. This requires the ability to thrive in team-oriented environments and ensuring a high degree of accountability, transparency, and understanding as it relates to the forecasting, reporting, accounting and operational performance of the organization. The successful candidate will be self-motivated, resourceful, have strong analytical skills and can thrive in a fast-paced biotech company. &nbsp; Key Responsibilities Enhance and maintain reports, models, and data integrations within Adaptive Planning (Adaptive Insights) Serve as a hands-on contributor supporting annual budgeting and forecasting cycles with Adaptive Planning, ensuring data accuracy, modeling consistency, and reporting logic Help enhance and standardize FP&amp;A processes, reporting packages, and financial analysis as the company scales Support month-end reporting activities, including preparation of actuals, cost trend analysis, variance analysis, and business partner reporting for G&amp;A functional areas Collaborate across G&amp;A functional teams to compile budgets, forecasts, and long-range plans Act as liaison between business partners and Accounting, supporting monthly and quarterly accruals in accordance with GAAP and SOX requirements Support broader organization through ad hoc projects and financial analyses, as needed &nbsp; Ideal Candidate Bachelor’s degree in finance or accounting, or related field 3 to 5 years finance/FP&amp;A experience with increasing levels of responsibility Prior employment at a publicly traded biotech company preferred Proficiency with excel, financial modelling, PowerPoint, and financial planning tools required (Adaptive Planning preferred) Knowledge of US GAAP and SOX principles required A natural curiosity to understand the business further, a sense of ownership for their work and an ability to develop strong working relationships Highly motivated, with ability to think strategically and prioritize, including a demonstrated ability to organize work effectively to meet deadlines Excellent communication skills; ability to work collaboratively with other parts of the business, including key internal and external stakeholders and executive management Ability to be flexible and work analytically in a dynamic, fast-paced environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $110,000-$120,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Financial Analyst, Financial Planning & Analysis

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary The Senior Director, Commercial Strategy will serve as a strategic commercial leader for a growing clinical‑stage biotechnology company with a diversified pipeline, including a lead asset in Atopic Dermatitis entering phase 3 clinical trials within the next 12 months and two additional programs in earlier clinical stage development. This role is responsible for supporting the ongoing planning and execution of the Company’s five-year U.S. commercial roadmap across a variety of initiatives, workstreams and projects. The Senior Director will work closely with Clinical, Medical Affairs, Business Development &amp; Strategy, Regulatory, Finance, and Executive Leadership to ensure commercial perspectives are integrated early and effectively throughout the development programs.&nbsp; In addition, the role will be responsible for building and executing a Commercial competitive intelligence process to keep up to date on the competitive market dynamics and developments across our prioritized therapeutic areas.&nbsp; The Sr Director, Commercial Strategy will report directly to the SVP, Commercial Strategy &amp; Operations. &nbsp; Key Responsibilities Work closely with Commercial Leadership Team in the development of a comprehensive commercial strategy and pre-launch plan for the Company’s lead asset in moderate-to-severe Atopic Dermatitis Oversee and maintain the execution of the 5-year U.S. commercialization roadmap across Operations, Marketing, Market Access and Sales through cross functional commercial projects and initiatives that will define the go-to-market strategy Partner with Commercial Leadership in the evaluation, assessment and implementation of commercial operating model which includes commercial processes, systems and capabilities as well as the organizational design &amp; structure to support commercialization Partner closely with Marketing &amp; Market Access organizations to understand the needs and operational support required by each organization pre and post launch and lead efforts to incorporate those into go-to-market planning Serve as a member of cross functional program team workstreams across various portfolio development programs to ensure Commercial perspective is accounted for in the plans of Clinical Development, Medical Affairs, and Regulatory functions Establish a market and commercial competitive intelligence process to help the organization stay up to date on the latest market changes and competitive dynamics that will shape asset positioning and target product profiles (TPPs) &nbsp; Ideal Candidate Bachelor’s degree required; advanced degree (MD, PhD, or other relevant graduate degree) preferred, particularly for candidates with management consulting or strategic advisory experience Approximately 10+ years of industry experience, including 5+ years of strategic consulting experience or strategy experience at a pharmaceutical or biotech company Broad experience across relevant commercial roles and functions, including at least one role with primary responsibility for commercial strategy development and execution Proven track record of shaping and executing effective commercial strategies in rapidly evolving biotech organizations, resulting in meaningful commercial impact Excellent verbal and written communication skills Advanced skills in Excel and PowerPoint, including the ability to build clear, data‑driven analyses and create executive‑ready presentation decks Ability to thrive in a remote work environment by engaging actively and building rapport with colleagues through virtual meetings and collaboration tools Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 20% travel including mandatory in-person attendance at All Hands meeting, typically held twice per year &nbsp; The anticipated salary range for candidates for this role will be $255,000- $285,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Director, Commercial Strategy

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking a&nbsp;Manager, Clinical&nbsp;Business Operations to join the&nbsp;Clinical Operations&nbsp;team at Apogee&nbsp;and focus on a specific therapeutic area.&nbsp;This role&nbsp;is responsible&nbsp;for&nbsp;providing&nbsp;Project&nbsp;Planning&nbsp;support for&nbsp;our dermatology or respiratory&nbsp;Clinical&nbsp;Programs.&nbsp;This position requires a&nbsp;self-starter, who&nbsp;can organize projects effectively in a fast-paced setting. If you are&nbsp;interested in&nbsp;utilizing&nbsp;your&nbsp;Clinical&nbsp;Operations and&nbsp;Project Management&nbsp;expertise&nbsp;to deliver innovative medicine to patients, enjoy&nbsp;a&nbsp;fast-paced&nbsp;environment,&nbsp;and thrive in a culture of growth and camaraderie, this role is for you.&nbsp;&nbsp;&nbsp; Key Responsibilities Maintain and communicate a current overview of&nbsp;Clinical Operations&nbsp;Program&nbsp;status and&nbsp;issues.&nbsp; Work with&nbsp;Clinical Operations&nbsp;team members to&nbsp;identify&nbsp;resource constraints, risks,&nbsp;and conflicts that could&nbsp;impact&nbsp;the&nbsp;team’s&nbsp;ability to deliver according to plans.&nbsp;&nbsp;&nbsp; Provide Project Management support for 1 or more&nbsp;Clinical&nbsp;programs, including building and&nbsp;maintaining&nbsp;the&nbsp;clinical&nbsp;study plans&nbsp;by interfacing with our external partners&nbsp;&nbsp; Collaborate closely with the cross-functional Program Management team to ensure integration of&nbsp;Clinical Operations&nbsp;activities into overall program plans,&nbsp;monitor&nbsp;project&nbsp;deliverables&nbsp;and ensure tasks are on track.&nbsp; Work collaboratively to create project planning guidelines/playbooks for use across&nbsp;projects.&nbsp; Establish and track key performance indicators (KPIs) and metrics to evaluate performance and&nbsp;identify&nbsp;areas for improvement&nbsp; Document, standardize and publish department processes and procedures while&nbsp;seeking&nbsp;to&nbsp;identify&nbsp;potential operating efficiencies&nbsp; Prepare reports, presentations, and other deliverables related to project updates, process improvements, or other business initiatives&nbsp; Participate in Work Order and Change Order&nbsp;negotiation,&nbsp;review,&nbsp;and approval.&nbsp; Submit purchase orders in NetSuite, review and approve vendor revenue recognition, accruals, and invoices&nbsp; Assist&nbsp;with tracking outsourced activities as needed.&nbsp; &nbsp;Ideal Candidate Bachelor’s degree in science&nbsp;&nbsp; 10+&nbsp;years of experience in&nbsp;biotech or&nbsp;pharmaceutical industry&nbsp;&nbsp; 3+ years of&nbsp;Clinical Operations&nbsp;experience&nbsp;&nbsp; Experience working with&nbsp;Clinical&nbsp;stage candidates across all phases of&nbsp;Clinical&nbsp;Development (e.g.,&nbsp;PhI&nbsp;to&nbsp;PhIII).&nbsp;&nbsp; Extensive&nbsp;knowledge&nbsp;of&nbsp;Smartsheet&nbsp;and/or&nbsp;Microsoft Project&nbsp; Confident&nbsp;and&nbsp;proactive&nbsp; Highly organized&nbsp;with&nbsp;meticulous&nbsp;attention to detail&nbsp; Ability to multi-task and keep pace with a fast-moving&nbsp;organization.&nbsp; Successfully&nbsp;exhibit&nbsp;Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless&nbsp;&nbsp; Ability and willingness to travel up to&nbsp;15% to company All Hands Meetings The anticipated salary range for candidates for this role will be $145,000 - $160,000.&nbsp; The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Manager, Clinical Business Operations

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities. This role will be a key member of the team supporting regulatory activities and regulatory execution for clinical trials across the portfolio.&nbsp; In collaboration with the Regulatory team, you will drive global submission planning and coordination across multiple regions, ensuring alignment with Regulatory, Global Development, and Technical Operations objectives.&nbsp; The ideal candidate is a proactive, detail-oriented project manager with global regulatory experience who thrives in a face-paced, collaborative biotech environment. Reporting to the Director of Program management, you will also work closely with other project and program managers within the Program Management Office (PMO) implementing robust PM processes and building effective tools and systems. You’ll support optimization of Regulatory project plans, schedules, stakeholder communications, and Smartsheet operations. The role involves developing and managing high-visibility regulatory submission plans, monitoring milestones, managing documentation, and contributing to regulatory strategy. Key Responsibilities This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts Work with the Regulatory team to translate strategic regulatory vision into actionable project plans, ensuring all cross-functional activities are coordinated and delivered on time Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide Monitor CTA/IND submission status across assigned projects Support strategic planning and risk mitigation efforts related to regulatory activities, including portfolio level analyses that identify resource bottle necks across all programs and studies Support evaluation, implementation, and use of project management tools (especially Smartsheet); define methodologies and reporting frameworks Design and maintain Smartsheet sheets, reports, dashboards, and forms related to regulatory activities and ensure integration with program plans Troubleshoot and enhance PMO solutions, support system updates and new capabilities Demonstrate critical thinking and initiative to improve PM practices Ideal Candidate Bachelor’s degree in life sciences, pharmacy, chemistry, or related field 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred Experience with planning IND/CTA regulatory submissions required Familiarity with components of regulatory submissions is required Experience planning BLA/NDA/MAA submissions is required Familiarity with CRO operations and global regulatory requirements for clinical trial applications Experience supporting global interventional clinical studies and CTA submissions Hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro). Familiarity with regulatory systems (Veeva RIM) preferred Knowledge of biotech processes, scientific terminology, drug development concepts Proactive and structured approach to problem-solving, with ability to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and meet deadlines Ability to work independently and thrive in a dynamic environment Team player that contributes valuable ideas and feedback and can be counted on to meet commitments Position requires up to 20% travel; this includes mandatory in person attendance to company All-Hands meetings held twice a year and frequent trips to Apogee offices in San Francisco and/or Boston The anticipated salary range for candidates for this role will be $150,000-$170,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Regulatory Affairs Project Management

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an inspirational and dynamic Regional Director (RD), Field Medical Affairs (Dermatology) to lead and expand our Medical Science Liaison (MSL) team in the East region.&nbsp; The ideal candidate will have an advanced clinical or scientific degree and experience in field medical affairs leadership within dermatology.&nbsp; In this newly created role, you will lead the MSL team to meet the field scientific objectives of the Clinical Development Medical Affairs (CDMA) organization.&nbsp; Your &nbsp;primary focus &nbsp;will include&nbsp; MSL coaching and development, territory planning and cross-functional collaboration to support our clinical trials and corporate strategy. Key Responsibilities MSL Leadership and Development - lead, coach and manage a team of MSLs Provide strategic direction, professional development, and performance management in a timely and consistent manner, regularly recognize strong performance and address performance gaps decisively Consistent field observations to provide MSL coaching and development and build relationships with key opinion leaders (KOLs) and investigators Regional execution of Medical Affairs strategy and objectives, ensure MSLs are equipped to engage with healthcare professionals (HCPs), KOLs, and other external stakeholders, delivering scientific and medical information that aligns with corporate strategy Regional oversight of MSL territory planning to achieve Medical Affairs objectives/goals Ensure MSLs have resources, tools and training to maximize field performance and enhance the support of KOLs and investigators Responsible for MSL team compliance, monitor and evaluate MSL activities, ensuring compliance with regulatory guidelines and internal policies Collaborate closely with cross-functional teams Provide scientific expertise and insights to help guide strategy and internal decision-making Ideal Candidate Advanced scientific degrees are required (PharmD, PhD, MD/DO, PA, NP), Doctorate strongly preferred in health sciences or clinical discipline Minimum of 7 years of experience in Medical Affairs and 5 years of experience in field medical affairs MSL leadership experience required 2+ years of experience in the dermatology therapeutic area strongly preferred Excellent communication and presentation skills Proven history of establishing and maintaining relationships with KOLs Ability to work in a fast-paced, dynamic biotech environment with a collaborative, cross-functional mindset Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 75% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as regular overnight travel to meet with MSL team, clinical study site personnel and KOLs, and to attend scientific conferences, etc. The anticipated salary range for candidates for this role will be $250,000 - $280,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Regional Director, Field Medical Affairs - East

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a highly motivated and results-oriented individual to join Apogee Therapeutics in an Associate Director, Clinical Supply Chain Management role. In this position, you will be responsible for managing the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.&nbsp; This role will collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards. The position is fully remote and reports to a senior member of the Clinical Supply Chain management team. Key Responsibilities Strategic Supply Chain Planning: Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements. Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered. Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc. Collaborate with manufacturing to develop drug product delivery schedules to meet demand. Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile. Establish SOP’s and work instructions required to manage clinical supply. Clinical Supply Management: Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance. Manage the label development process. Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services. Develop IRT User Requirement Specifications and conduct User Acceptance Testing. Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity. Inventory &amp; Distribution Oversight: Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials. Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages. Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements. Regulatory Compliance &amp; Quality Assurance: Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities. Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities. Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives. Leadership &amp; Cross-functional Collaboration: Lead and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities. Serve as a key point of contact with multiple functional areas and act as a liaison between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines. Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they arise. Ideal Candidate S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field with 12+ years of relevant experience in supply chain management and 5+ years in a leadership role. Certification in Supply Chain Management or Project Management a plus Experience with inventory and supply chain management for complex global clinical trials using Microsoft Excel based models and SaaS forecasting tools Operations experience in a biotech or pharmaceutical company, start-up experience a plus Third-party selection and management experience is required Knowledge of import/export requirements and significant experience with international clinical supply Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP) Proven ability to manage multiple projects, proactively identify and mitigate risks, and resolve issues using strong attention to detail and problem-solving skills Experience developing and managing program budgets Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smart Sheet Excellent communication and influencing skills, strong collaboration skills Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. Ability and willingness to travel up to 15% (domestic and internationally) including a minimum of 2 times per year for All Hands meetings The anticipated salary range for candidates for this role will be $170,000-$190,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Supply Chain Management

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director of Statistical Programming. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests. Key Responsibilities Serve as a lead statistical programmer on one or more clinical studies Provide statistical programming oversight to programming vendors Review and validate datasets and TFLs programmed by vendors Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate Participate in developing and implementing statistical programming processes and standards Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective Build and mentor a team of programmers to support clinical trials and pipelines Generate ad hoc analyses on ongoing basis Ideal Candidate Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry Advanced SAS programming skills and experience in other statistical software, such as R, etc. Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies Excellent organizational skills and ability to prioritize tasks Excellent communication and interpersonal skills Experience managing CROs and other data vendors Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment Ability to keep pace in a fast-moving organization Advanced knowledge of state-of-art statistical programming methods in clinical study setting. Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience working with in a remote virtual environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $190,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.&nbsp; Key Responsibilities Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project&nbsp;objectives&nbsp;are met&nbsp; Initiate and build strong relationships with key opinion leaders and clinical site staff Partner with the CRO&nbsp;to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget&nbsp;for assigned regions Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data Proactively&nbsp;identify&nbsp;and manage study related risks Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs),&nbsp;and&nbsp;consents Review and manage study related plans and processes including Investigator agreements (CTA),&nbsp;site budget review,&nbsp;CRFs, CRF guidelines,&nbsp;Statistical&nbsp;Analysis Plans, Pharmacokinetic&nbsp;Analysis&nbsp;Plans,&nbsp;Monitoring plan,&nbsp;Data&nbsp;Management&nbsp;Plan, and&nbsp;Safety&nbsp;Monitoring&nbsp;Plan Collaborate with Regulatory/CRO team members to&nbsp;assist&nbsp;with completion/review of regulatory submissions Review CRO and vendor contracts/work orders and specifications to align with study objectives Review specifications for systems build and&nbsp;participate&nbsp;in User Acceptance Testing (UAT) (eg, IRT,&nbsp;eCOA, EDC) Participate in data cleaning and manage database lock&nbsp;activities&nbsp;with cross functional team Oversee review and approve essential document packages to enable&nbsp;timely&nbsp;site activations Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Participate in&nbsp;TMF&nbsp;review&nbsp;and ensure&nbsp;quality and&nbsp;completeness&nbsp;throughout&nbsp;end of the study Ensure the study is always “inspection ready”&nbsp; Oversee and coach the functional activities of Clinical Trial Associates&nbsp;allocated&nbsp;to the project&nbsp; Ideal Candidate Bachelor’s degree in life science or equivalent Minimum of 5 years of clinical trial management experience in conducting international clinical trials in&nbsp;a Sponsor Pharma/Biotech organization.&nbsp;&nbsp;Biotech experience strongly preferred.&nbsp;&nbsp; Prior phase II and III experience&nbsp;required A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Proven&nbsp;proficiency&nbsp;in overseeing complex studies being managed in house and by a CRO Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively Experience selecting and managing clinical vendors to support study activities Enjoys building relationships with KOLs and site personnel Demonstrated ability to build and deliver on patient enrolment strategies Demonstrates innovation,&nbsp;possesses&nbsp;drive, energy, and enthusiasm to deliver the program objectives Demonstrated ability to review and&nbsp;comprehend&nbsp;complex scientific concepts and clinical data Strong planning, time management,&nbsp;and coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Excellent written and oral communication skills Position requires up&nbsp;to 35%travel, including mandatory&nbsp;in-person&nbsp;attendance at Apogee All Hands meetings typically held twice per year.&nbsp;Travel is also&nbsp;required&nbsp;to attend key Phase 3 meetings,&nbsp;typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.&nbsp; The anticipated salary range for candidates for this role will be $145,000- $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs. Key Responsibilities Act as a central contact for the&nbsp;cross-functional&nbsp;study&nbsp;team for designated project communications, correspondence, and associated documentation Maintain&nbsp;and perform QC reviews on&nbsp;study specific electronic Trial Master Files&nbsp;to ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices Track and report study metrics; inclusive of start-up, data management, and contracting as needed Participate in&nbsp;GxP&nbsp;audits and related clinical compliance activities Prepare and track study documents (e.g., contracts, budgets, IRB documentation) Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.)&nbsp;and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards Administer user access and change control within Apogee’s electronic systems Assist&nbsp;in User Acceptance Testing for all EDC needs&nbsp;in regard to&nbsp;Data Management and all Clinical Systems Assist&nbsp;with vendor management and associated&nbsp;logistics, as assigned Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations Collaborate with Clinical Project Manager, Clinical Supply&nbsp;Unit&nbsp;and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs,&nbsp;monitors&nbsp;and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to&nbsp;assist&nbsp;with clinical monitoring duties upon completion of required training.&nbsp;&nbsp; Organize and/or&nbsp;participate&nbsp;in meetings with CROs. Ensure&nbsp;appropriate meeting&nbsp;minutes are prepared and filed in TMF Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information Assist&nbsp;in creating and implementing departmental procedures&nbsp;Assist with information gathering, literature searches, and creation of presentations, as needed Responsible for managing team training assignments and oversight/ownership of due dates to support compliance Ideal Candidate BS/BA in Life Sciences or equivalent 4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&amp;D environment Extensive experience&nbsp;with&nbsp;TMF, including set-up, maintenance, QC/ QR&nbsp;and query management. Familiar with DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated&nbsp;proficiency&nbsp;in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while&nbsp;maintaining&nbsp;high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, SmartSheet, and ISI Toolbox Strong critical thinking, organizational and time-management skills Successfully&nbsp;exhibit&nbsp;Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position&nbsp;requires&nbsp;up&nbsp;to 15-20%travel,&nbsp;including mandatory&nbsp;in-person&nbsp;attendance at Apogee All Hands meetings typically held twice per year.&nbsp;Travel is also&nbsp;required&nbsp;to attend key Phase 3 meetings,&nbsp;typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.&nbsp; The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, Clinical Operations Standards and Planning to join our Clinical Operations Team. This position will be responsible for the identification, documentation, maintenance and optimization of Apogee Clinical Operations standards and best practices to support a growing portfolio of global clinical trials. This position will lead the Clinical Operations organization to identify innovative strategies to increase operational efficiency across programs.&nbsp; Additionally, this role will provide oversight of the Clinical Operations resource planning process to support the Clinical Operations Leadership Team in ensuring appropriate resources are available at the right time to support the Apogee portfolio. This role will report into the Executive Director Process and Strategic Planning and will be a key leader within the Clinical Trial Excellence Team. Key Responsibilities Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements Lead and participate in key process improvement initiatives to ensure continuous process improvement Lead any assigned departmental activities to support a highly functioning Clin Ops organization Ideal Candidate Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role Bachelor’s degree required Experience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendors Experience driving innovation in clinical trial operations to increase efficiency and implement best practices Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence Experience managing CROs, vendors and/or clinical trial consultants Strong leadership, communication, and interpersonal skills, with the ability to influence and align diverse groups across functions at all levels of the organization Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations Systems thinker with process optimization mindset and ability to build structure in dynamic, high-growth environments Strong project management skills, effective matrix leadership, and the ability to deliver Strong analytical and forecasting capabilities with demonstrated experience in capacity modeling, utilization optimization, and data-driven decision-making Ability and thrive in a fast paced, dynamic environment Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 30% travel The anticipated salary range for candidates for this role will be $175,000 - $195,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Operations Standards and Planning

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Associate Director, Analytical Development to join our team in Analytical Development and Quality Control. This newly created position is a highly collaborative leadership and technical position based in our Research and Development lab in Boston. You will manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities. These activities include supporting developability screening studies, method development, non-GMP analytical characterization, comparability and R&amp;D sample testing. In this role you will be an important member of the Tech Ops team, managing multiple activities in parallel at various stages of drug development. Key Responsibilities Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities. The work will include partnership with contracted partners and/or internal analytical capabilities. Design, manage and execute experiments to support developability screening, upstream/downstream process development, process transfer, formulation studies, product characterization and comparability studies. Develop and execute analytical strategies with other stakeholders in support of the product and analytical method lifecycle, ensuring compliance with safety, quality, and regulatory requirements. Demonstrate technical excellence in method development and analytical characterization/comparability of biologics; build strong partnerships and collaborations internally and externally. Collaborate with cross-functional teams, including process development and R&amp;D, to support project goals and timelines. Analyze and interpret complex data sets, providing clear and actionable insights and recommendations. Prepare technical reports, presentations, and documentation to communicate findings and progress to stakeholders. Author and review analytical sections of IND, IMPD, BLA, and MAA submissions. Stay current with industry trends, advancements to continuously improve analytical capability, methodologies and practices. Ideal Candidate PhD in Analytical Chemistry, Biochemistry, or related field, with a minimum of 7 years of relevant industry experience in an analytical development role, preferred. Demonstrated expertise in managing analytical development initiatives for monoclonal antibodies and other biologic modalities, encompassing method development, product quality assessment, characterization, and comparability studies. Deep expertise in several analytical techniques such as mass spectrometry, H/UPLC (SEC, IEX, RP, HILIC,), electrophoresis (CE-SDS, icIEF) and/or biophysical methods. Experience in ELISA, bioassay and potency assays is preferred. Experience in working with external contract organizations (CDMO, CRO, etc.) to deliver key analytical deliverables. Strong problem-solving skills and the ability to lead, design, troubleshoot, and conduct complex experiments. Excellent communication skills with an ability to collaborate effectively across functional lines. Strong organizational and project management skills, with the ability to manage multiple projects simultaneously. Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) related to analytical development and comparability Successfully exhibit Apogee’s&nbsp;C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 35% for company-wide meetings as well as Tech Ops team meetings. This hybrid role requires approximately two days per week onsite at our laboratory in Boston (Seaport area). The anticipated salary range for candidates for this role will be $175,000 – $195,000 /year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Analytical Development

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales. The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations. They build and lead a high‑performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA. Key Responsibilities Head of GMP QA and member of the QA Leadership Team Build, lead, and scale a high‑performing GMP QA team Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH) Lead organizational readiness for GMP internal audits and regulatory inspections Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner Engage effectively with leadership and key cross‑functional partners, bringing forward clear recommendations and risk‑based perspectives Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and to foster continuous improvement initiatives to support speed, clarity, and scalability Ideal Candidate 15+ years of progressive GMP QA experience within pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post approval operations Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional lead for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across internal teams and external partners Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities Significant leadership experience, including managing managers and senior level professionals; effective at coaching and developing leaders through change and uncertainty Ability to create and clearly articulate a GMP QA vision aligned with company strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs Sound, unbiased judgment in complex and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs Strong written and verbal communication skills Ability to operate effectively in a fast‑paced, evolving environment with incomplete information Demonstrated commitment to Apogee’s C.O.R.E. values and ethical decision‑making Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year and travel related to GMP manufacturing The anticipated salary range for candidates for this role will be $275,000-$305,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Executive Director, GMP Quality Assurance

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary The Department of Research and Translational Medicine is seeking a Clinical Biomarker Operations Sr. Manager. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management. Key Responsibilities Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition. Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications. Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions. Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance. Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships. Support QA in vendor audit and inspection activities. Support activities related to biomarker budget planning and tracking of accruals. Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards. Continuously identify and build best practices for process improvements. Ensure high quality data generation by overseeing sample integrity and external collaborations. Ideal Candidate&nbsp; MS or higher with &gt; 3 years or BS with &gt;5 years of direct experience in biomarker operations role. Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage. Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities. Experienced in all phases of clinical trials, Phase 3 experience is an asset. Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general. High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines. Experience in I&amp;I indications. Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines. Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops. The&nbsp;anticipated&nbsp;salary range for candidates for this role will be&nbsp;$150,000-$170,000 / year.&nbsp;The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary The Senior Manager of Clinical Systems serves as the clinical systems manager and technical lead for clinical technology initiatives. This position is responsible for the oversight, planning, and execution of end-to-end clinical system processes from start up through archival. This role combines clinical systems expertise with strong technical project management capabilities, ensuring successful delivery of system implementations, integrations, and enhancements. This position will provide technical and business management in support of system compliance and inspection readiness, while driving structured execution of cross-functional initiatives. The role requires strong collaboration across Clinical, IT, Quality, and external vendors to manage timelines, risks, dependencies, and change management activities. This position will also lead efforts to define requirements, promote adoption of processes and standards, act as a point of escalation and ensure alignment with company goals, culture, and vision. Key Responsibilities Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors. Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking. Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager. Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting. Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner. Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor teams for successful system implementation. Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles, applicable regulations, GCP requirements, and industry standards. Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed. Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required. Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices. Collaborate with Information Technology (IT), Quality Assurance, and Clinical System Validation teams to ensure effective system implementation, integration, and lifecycle management, including releases, updates, bug fixes, and enhancements. Oversee system integrations and data flows across platforms (e.g., CTMS, IRT, eCOA, eTMF, LMS), ensuring data integrity and interoperability. Create and provide clinical system training. Act as a primary support role for clinical system users and stakeholders. Execute change management activities to ensure consistent application of revised standards, processes, and systems functionality, including validation. Ideal Candidate (Enhanced with Technical PM requirements) Bachelor's Degree or higher or equivalent experience. At least 10 years of experience successfully managing clinical system activities for clinical research/biotech/pharmaceutical organizations. Experience implementing and managing eCOA, IRT, eTMF, CTMS and LMS (Veeva Vault experience preferred). Experience with implementation and integration of clinical systems and writing/revising SOPs related to clinical systems. Experience with computer system validation/assurance processes. Demonstrated experience applying project management methodologies (Agile, Waterfall, or hybrid) to deliver complex, cross-functional technical initiatives. Proven ability to define project scope, timelines, milestones, and resource plans, and manage execution with clear accountability. Strong program management skills, including risk management, dependency tracking, issue escalation, and stakeholder communication. Working knowledge of data management principles, including data quality, data governance, and data lifecycle management in clinical systems environments. Ability to interpret and analyze data outputs, dashboards, and KPIs to drive operational decisions and continuous improvement. Familiarity with AI/ML concepts and terminology (e.g., automation, predictive analytics, NLP) and their practical applications in clinical operations. Familiarity with software development lifecycle (SDLC) processes, including requirements gathering, UAT, release management, and post-implementation support. Proficiency with project management and tracking tools (e.g., Smartsheet, MS Project, or similar). Experience managing teams in the successful execution of projects; knowledge of records management practices in pharma/biotech or CRO environments. Strong software and computer skills, including Microsoft Office applications. Knowledge of relevant licensing and industry compliance regulations. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. Demonstrated effective written and verbal communication skills with internal and external stakeholders, including the ability to communicate complex technical concepts clearly. Able to lead initiatives and communicate effectively through presentations for external and internal audiences. Excellent organizational skills with outstanding attention to detail and follow-through. Able to work independently and function as a team player. Able to navigate complex problems, develop advanced concepts, anticipate challenges, and propose solutions. Optional PMP, PgMP, or equivalent certification preferred. Experience in high-growth biotech or startup environments. The&nbsp;anticipated&nbsp;salary range for candidates for this role will be&nbsp;$150,000-$165,000 / year.&nbsp;The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Clinical Systems

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Senior Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Director of Regulatory Affairs, you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role, you will lead the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams. Key Responsibilities Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs, among others Support the data collection and cross-functional authorship for regulatory documents. Proofread, edit, and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members With mentoring and guidance from the regulatory affairs leadership team, understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables, timelines, and objectives are met Ideal Candidate BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline Regulatory Affairs Certification (RAC) credential preferred A minimum of 5 years of regulatory experience working in drug development in the biopharmaceutical industry Experience interacting with health authorities including FDA and EMA Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $155,000-$175,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Regulatory Affairs

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a dynamic and results-driven Director of GMP Quality Assurance (QA) to join our team. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.) This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. You will support our mission to develop and deliver differentiated biologic therapies to patients in need. Key Responsibilities Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities Independently performs assigned GMP audits Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.) Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness Ensure employees are adequately trained in GMP requirements and quality procedures Maintain comprehensive and accurate records and reports related to quality assurance activities Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety Assist in GMP inspection readiness activities to support regulatory authority inspections Ideal Candidate A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics Experience with CDMO oversight, including partnering and aligning on quality issues Experience with Quality Management System Regulations is a plus In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements Experience with analytical instrumentation, methods, validation, and investigations including stability program management Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change Excellent problem-solving and critical thinking abilities Flexible and creative to meet the needs and challenges of a growing, dynamic company Focus on fostering a culture of collaboration and teamwork Ability to manage multiple projects with fast timelines and changing priorities Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $210,000-$235,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, GMP Quality Assurance

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary Plan track and manage biomarker sample logistics across all our clinical trials, oversee sample shipment and testing at vendors, complete sample reconciliation as needed, plan and inform teams on data delivery timelines and manage final sample disposition. Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICF and lab manuals, and oversee finalization of data transfer specifications. Support the setup and ongoing management of a sample inventory database. This includes participating in the development of a biomarker sample inventory strategy, selecting third-party vendors for long-term sample storage, overseeing the tracking of sample collection, and coordinating shipment of samples to external testing partners Support Biomarker related QA activities, including participating in gap analysis of biomarker departmental processes as part of inspection readiness Coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships. Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Finance, Procurement and Quality Assurance. Support activities related to biomarker budget planning and tracking of accruals. Lead vendor selection, performance management and oversight to ensure compliance to Apogee standards Continuously identify and build best practices for process improvements. Ideal Candidate&nbsp; MS or higher with &gt; 3 years or BS with &gt;5 years of direct experience in biomarker operations role. Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection through to long-term storage. Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking and final reconciliation of activities. Experienced in all phases of clinical trials Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays and drug development in general. High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines. Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel including a minimum of ~4 times per year for All Hands meetings and other workshops. The anticipated salary range for candidates for this role will be $150,000-$170,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables Manage and oversee CROs and external vendors to ensure quality and compliance with expectations Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input Mentor and develop programmers, fostering a high-performing and collaborative team environment Provide hands-on support for complex analyses and ad hoc requests as needed Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows Ideal Candidate Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience Advanced SAS programming skills: experience with R or other statistical programming languages preferred Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology Experience supporting regulatory submissions (e.g., NDA/BLA/MAA) Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process Excellent organizational skills with the ability to manage multiple priorities Strong communication and interpersonal skills, with the ability to collaborate cross-functionally Experience managing CROs and external data vendors Demonstrated ability to mentor team members and contribute to team development Advanced knowledge of statistical programming methodologies in clinical study settings Knowledge of ICH guidelines and FDA / EMA / other regulatory authority requirements Experience working in a fast-paced, growth-oriented environment Experience working in a remote/virtual environment Experience with AI-driven tools or automation in clinical data analysis and regulatory submission processes (e.g., AI-assisted generation, validation, or review of submission deliverables) Familiarity with modern data platforms, cloud environments, or scalable analytics infrastructure Experience in a small to mid-size biotech environment Strong leadership with a collaborative and growth-oriented mindset High attention to quality and detail Adaptability and ability to operate effectively in a fast-moving environment Commitment to fostering a psychologically safe and inclusive team culture Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $270,000 - $295,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Director, Statistical Programming

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Senior Associate, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. You will have the opportunity to support the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will be a data steward of regulatory information, working closely with Regulatory Operations. Key Responsibilities Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments) Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness Support inspection readiness activities (e.g., TMF health checks, document completeness reviews) Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes Ideal Candidate BS (or equivalent) in related scientific discipline 2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred) Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders Proven proficiency in MS Word, Excel, Power Point; SharePoint/Teams (preferred) Experience working in Veeva Regulatory Information Management (RIM) platform and eCTD submissions (preferred) Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. The anticipated salary range for candidates for this role will be $120,000-$135,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Associate, Regulatory Affairs

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Director of Medical Writing. Key Responsibilities Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents. Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones. Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication. Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials. Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently. Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance. Helps define and implement best practices for the responsible use of AI within medical writing workflows. Provides guidance to less experienced medical writers and external vendors. Ideal Candidate Bachelors in science (advanced degree is a plus), with 8+ years of experience in medical writing in the pharmaceutical or biotech industry. Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment Experience with independently authoring a range of scientific documents and the ability to oversee such authoring done by third parties Detail-oriented, with exceptional organizational and project management skills Proficient in using scientific writing tools (eg, Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications. The&nbsp;anticipated&nbsp;salary range for candidates for this role will be&nbsp;$160,000-$180,000 / year.&nbsp;The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Manager, Medical Writing

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary Channel Strategy Conduct market research on distribution strategies and trends within Immunology and Atopic Derm to understand the current distribution landscape and network Define and lead Apogee’s enterprise channel strategy across wholesale, specialty distribution, and specialty pharmacy networks as we advance our pipeline into commercialization Design optimal distribution models (e.g., open vs. limited networks, specialty pharmacy, hub integration) aligned with product strategy, patient journey, and access goals As we approach launch, design and implement a high-performing specialty pharmacy network, including selection criteria, network size, and performance management framework Lead the negotiation, contracting, and ongoing management of wholesalers, specialty distributors, and specialty pharmacies Ensure network readiness for product launch, including data integration, reporting, inventory, and patient onboarding workflows Build and maintain senior-level relationships with key trade and distribution stakeholders to position Apogee as a partner of choice Continuously assess and optimize network performance to improve speed to therapy, patient experience, and adherence Patient Support Strategy &amp; Operations Conduct a patient services landscape assessment across Atopic Derm brands, other Dermatology brands to benchmark the scope of offerings and programs in the current market to guide in shaping Apogee’s patient services Build and lead a comprehensive patient support program, including hub services, benefits investigation, prior authorization support, co-pay assistance, patient education, and adherence programs Build and lead a team of Formulary Reimbursement Managers that will build relationships and provide industry-leading support to HCPs on reimbursement dynamics and challenges Ensure a seamless, patient-centric experience from prescription through therapy initiation and persistence Select, onboard, and manage vendors supporting patient services and hub operations Define and track KPIs (e.g., time to therapy, abandonment rates, adherence) and drive continuous improvement Additional Responsibilities Partner cross-functionally with Market Access, Commercial Strategy, Supply Chain, Medical, Regulatory, and Legal to ensure aligned and compliant execution Provide input into forecasting, financial modeling, and scenario planning related to distribution and patient services Build, lead, and develop a high-performing team across channel strategy, trade relations, and patient support Coach and develop talent, establishing capabilities needed for future growth and launches Ideal Candidate Bachelor’s Degree or equivalent. An advanced business degree or an MBA is a plus Minimum 10 years of industry experience in Trade Relations/Channel Strategy and/or Patient Services and Support. Experience with Specialty products or Immunology a plus Proven track record of consistently achieving and exceeding expectations in current and prior positions Deep expertise in specialty pharmaceutical supply chain and patient services programs strategy and operations Strong negotiation skills, experience with wholesaler distribution service agreements, and management of day-to-day relationships Experience building and employing a high-performance specialty pharmacy distribution network Excellent communication skills with proven ability to present to large and small audiences Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel, including mandatory in-person attendance at Apogee All Hands meetings, typically held two times per year, and travel to functional meetings and industry conferences The anticipated salary range for candidates for this role will be $280,000-$305,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Director, Channel Strategy and Patient Support

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced Director of US Insights and Market Development to serve as a senior, strategic, thought partner to U.S. commercial leadership and to lead all market research strategies and initiatives. This role reports to the Executive Director, Pre-Commercial&nbsp; Marketing.&nbsp; This newly created role will act as the senior member on cross-functional leadership teams, responsible for identifying and activating opportunities that unlock value from data-driven insights and advising on transformational &nbsp;business drivers.As a member of a growing Commercial team, you will help to frame complex business challenges that enable clear decision making and effective execution to drive impact. You will integrate insights from multiple analytic disciplines, lead day-to-day problem solving, and foster stakeholder engagement. The Director of US Insights and Market Development applies deep functional expertise, strong intellectual curiosity, and collaborative problem-solving to deliver high quality, actionable insights while building trusted partnerships. Key Responsibilities Develop and execute integrated market research strategies to drive pre-commercialization activities, launch readiness, go-to-market strategy, and brand strategy. Proactively lead annual insights generation strategy tied to brand plan objectives/key strategic decisions/CSFs. Serve as a senior, strategic, thought partner to the Commercial team by framing and answering high impact business questions related to brand strategy, execution, and investments. Design both qualitative and quantitative primary market research with HCPs, patients, caregivers, and other stakeholders. Align insights across analytics functions, especially as it informs forecast, so that senior leadership has a consistent, clear view of the market opportunity. Manage external research agencies, manage budget, and right-size market research for business decisions. Serve as the trusted advisor on unbiased voice of the customer. Develop and communicate actionable insight summaries to senior leadership to influence high-stakes decisions. Must be skillful at storytelling to translate technical and complex findings into simple and actionable solutions. Develop and lead initiatives to harness the power of AI in market research, data analytics, KPIs, and other pre-launch and launch activities. Design and maintain dashboards, KPIs, and reporting tools that provide visibility into performance and effectiveness. Analyze and synthesize complex datasets to generate actionable insights that inform marketing, and customer engagement strategies. Diagnose performance gaps and recommend optimal, data-driven actions and enhanced strategies. Work proactively and independently as needed, and collaborate effectively to drive change across a growing organization. Foster strong project management skills with experience structuring projects, directing cross-functional accountability, and driving productive meetings &amp; timely deliverables. Ideal Candidate BA/BS in a quantitative discipline is required, such as Mathematics, Statistics, Engineering, or Economics. MS and/or MBA strongly preferred 10+ years of progressive experience in a pharmaceutical or biotech company or management consulting in market research/data science roles including significant experience leading market research on pre-launch and in-line products in a competitive environment Proven track record across strategic analytics functions, including secondary data analytics, data science, market research, commercial analytics, and management consulting Experience in dermatology or atopic dermatitis is preferred Experience building analytic plans, leading research projects is required Position requires up to 20%* travel including mandatory in-person attendance at All Hands meetings held twice per year. Additional travel may be required to attend key team meetings and medical or industry conferences, both in the US and Europe. The anticipated salary range for candidates for this role will be $235,000 - $255,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, US Insights and Market Development

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary &nbsp; We are seeking an experienced non-MD Clinical Scientist. As a Director in Clinical Development, you will support the scientific planning and execution of one or more clinical trials in inflammation &amp; immunology. This highly visible role involves co-leading studies with a Medical Director and working closely with cross-functional teams to design, implement, oversee and analyze clinical studies to advance the development of innovative therapies in our pipeline, including our lead dermatology clinical program. In this role you will contribute scientific expertise and strategic insights to ensure the successful progression of clinical programs. &nbsp; Key Responsibilities · Collaborate with cross-functional teams to develop clinical documents for trials with scientific rigor, such as protocol, investigator brochure, clinical study report, scientific publications/presentations, etc. · Contribute scientific input and implementation into the study design and execution, including but not limited to selection of appropriate endpoints, patient populations, and study methodologies; site selection; investigator meetings; and study initiation activities · Monitor the clinical trials for both quality and safety, ensuring adherence to protocols, timelines, and quality standards · Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making · Collaborate with data management and biostatistics to develop and validate data collection tools and ensure accurate and timely data capture · Foster relationships with clinical investigators to gather insights, address scientific questions, and promote collaboration · Stay current with scientific literature and advancements in immunology related to Apogee’s pipeline · Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals &nbsp; Ideal Candidate · Advanced degree in life science field (e.g., PhD, PharmD, or DVM) · Must have 5 +years of experience in research, with 2+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry preferred; focus on immunology and/or dermatology preferred · Strong understanding of clinical trial design, execution, and data analysis · Analytical mindset and ability to interpret complex scientific data · Ability to manage multiple competing priorities with good planning, time management and prioritization skills · Strong communication, technical writing, and presentation skills, with the ability to effectively convey scientific concepts to diverse audiences · Proven ability to work in a cross-functional team environment · Solid knowledge of Good Clinical Practice (GCP) and ethical guidelines governing clinical research · Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless · Position requires approximately 35% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. &nbsp; The anticipated salary range for candidates for this role will be $230,000-$260,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Clinical Development (Clinical Science)

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking an experienced Medical Science Liaison (MSL) with expertise in asthma and a strong understanding of the immunologic pathways driving disease, including Type 2 inflammation and biomarker-driven treatment approaches. This individual will support Apogee’s respiratory clinical development programs while serving as a trusted scientific partner to pulmonologists, allergists, investigators, and key opinion leaders (KOLs), driving meaningful scientific exchange and delivering insights to inform clinical strategy and advance innovative therapies in asthma. Territory: Dependent on candidate location Key Responsibilities Clinical Support: Collaborate with clinical study teams to provide medical and scientific support to clinical trial sites Support site engagement, education, and execution of respiratory (asthma-focused) clinical studies Key Opinion Leader (KOL) Engagement: Develop and maintain strong relationships with investigators, key opinion leaders, and external stakeholders, including pulmonologists and allergists/immunologists Serve as a credible scientific resource, providing timely, accurate, and relevant information on Apogee’s development programs Stay current on emerging data, publications, and clinical trends in asthma and respiratory disease to effectively engage external experts Maintain awareness of competitor products, biologics, and evolving treatment paradigms in asthma Internal Collaboration: Partner cross-functionally with Medical Affairs, Clinical Development, Clinical Operations, and Business Development &amp; Strategy to ensure alignment Gather and communicate actionable field insights to inform clinical strategy and development decisions Ideal Candidate Advanced degree in a relevant medical or scientific field (MD/DO, PharmD, PhD, Master’s Degree, or equivalent) Minimum of 3 years of industry experience as a Medical Science Liaison, with expertise in respiratory (asthma) Strong understanding of clinical study execution and appropriate interactions with clinical study sites Familiarity with compliance requirements related to medical affairs activities and appropriate interactions with healthcare professionals Knowledge of the respiratory therapeutic area and current treatment paradigms in asthma Excellent communication and presentation skills Ability to build and maintain relationships with key opinion leaders and healthcare professionals Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 40% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. Additional travel may be required to attend key team meetings and medical or industry conferences, both in the US and in Europe. The anticipated salary range for candidates for this role will be $210,000 - $235,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Science Liaison - Respiratory

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a strategic, highly experienced Executive Director, Medical Affairs with deep expertise in eosinophilic esophagitis (EoE). This individual will lead the development and execution of Apogee’s global Medical Affairs strategy for EoE, including the development of a clinical site engagement plan, KOL engagement plan, congress presence, advisory board needs, and subject matter expertise on publications and medical communications. This role also includes working closely with many cross-functional stakeholders, including but not limited to, clinical development, clinical operations, biometrics, research and translational medicine, regulatory affairs, business development and strategy, and commercial. Key Responsibilities Develop and execute global Medical Affairs strategy for EoE Serve as a senior, strategic, thought partner across multiple teams and forums within Apogee Establish global KOL relationships and build scientific leadership in the field Support clinical development, site identification, and evidence generation Collaborate cross-functionally across multiple teams Ensure compliance with all regulatory standards Ideal Candidate Advanced professional degree (PharmD, PhD, MD/DO) 10+ years in a progressive biotech or pharmaceutical company with significant experience leading Medical Affairs strategy Strong expertise in EoE required Additional experience in other inflammation and immunology disease states preferred Proven track record of success in Medical Affairs Excellent communication and strategic thinking Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 40% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. Additional travel may be required to attend key team meetings and medical or industry conferences, both in the US and Europe The anticipated salary range for candidates for this role will be $305,000 - $340,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Executive Director, Medical Affairs - Eosinophilic Esophagitis (EoE)

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Sr. Medical Director to lead the EoE (eosinophilic esophagitis) clinical development program. In this newly created role, you will serve as the EoE subject matter expert, overseeing clinical execution and medical monitoring of EoE studies. You will be responsible for seamless execution of trials and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitoring activities. If you thrive in a fast-paced environment and seek the opportunity to advance new clinical programs into later stages of development, this role is for you! &nbsp; Key Responsibilities Participate in the design and execution of clinical studies in a new therapeutic area (Gastroenterology) Contribute clinical and strategic perspective to EoE development program through BLA Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution, including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan Contribute to the design of trials, and develop protocols and other relevant documents for individual studies Lead study start-up activities Direct day-to-day clinical and medical execution of studies Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan Partner with clinical operations on site selection, recruitment, and CRO management Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards and Investigator Meetings Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable &nbsp; Ideal Candidate Education – MD is required Board certification in Gastroenterology a plus (not required) 4 + industry experience as a medical monitor and/or medical director Experience working on phase 2 and 3 clinical studies in Gastroenterology or related immunological conditions Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year and functional meetings, study-related activities, and medical conferences. Intermittent travel to the Apogee office in San Francisco may be required. &nbsp; The anticipated salary range for candidates for this role will be $350,000 to $375,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Sr. Medical Director, Gastroenterology

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary As&nbsp;Director, IT&nbsp;–&nbsp;AI&nbsp;Enablement, reporting to the Sr. Director of IT – Digital Strategy &amp; Enterprise Architecture, you will shape and execute Apogee’s AI strategy across the enterprise, translating emerging technology into clinical, operational, and competitive advantage. You will set the strategic direction for how AI is adopted, governed, and measured at Apogee, while maintaining day-to-day operational ownership of the AI program, tool ecosystem, and governance framework.&nbsp; You will serve as the primary AI thought leader for the organization, advising senior leadership on where to invest, what to govern, and how to build durable AI capability in a regulated environment. You will work across every function and will be expected to operate with the credibility of a technologist and the instincts of a strategist. &nbsp; Key Responsibilities &nbsp; Program Operations &amp; Adoption&nbsp; Own end-to-end execution of the AI Enablement Program: working group facilitation, use case pipeline management, adoption tracking, and executive reporting&nbsp; Drive AI literacy and responsible use across a diverse workforce, meeting employees where they are and building capability without coercion&nbsp; Design and deliver training and engagement programs calibrated to varied audience profiles and functional contexts&nbsp; Manage the use case intake pathway from submission through scoring, cross-functional review, and outcome documentation&nbsp; Coordinate with external AI strategy and implementation partners to&nbsp;maintain&nbsp;an integrated, non-duplicative delivery pipeline&nbsp; Cross-Functional Collaboration&nbsp; Partner with Cybersecurity on AI tool security reviews, access control requirements, audit logging, and risk response protocols&nbsp; Collaborate with Legal and Compliance on data privacy, IP risk, MNPI controls, and contractual obligations across AI deployments&nbsp; Work with Data Engineering &amp; Analytics to align AI tools with the enterprise data platform and govern data access across regulated and non-regulated environments&nbsp; Engage Clinical Operations, Regulatory Affairs, and&nbsp;Medical&nbsp;teams to surface, prioritize, and advance AI use cases in trial and submission workflows&nbsp; Partner with Finance, HR, Commercial, and G&amp;A leadership on non-clinical use case discovery and deployment&nbsp; Facilitate the AI Working Group,&nbsp;maintaining&nbsp;cross-functional accountability and structured deliberation on tool assessments and program priorities AI &amp; Agent Ecosystem Ownership&nbsp; Serve as the enterprise&nbsp;administer&nbsp;on the AI and agent tool landscape,&nbsp;owning tool&nbsp;selection, lifecycle management, and the capability roadmap across LLM platforms, agentic workflows, productivity tools, and clinical AI applications&nbsp; Evaluate net-new tools and agentic frameworks through the governance assessment pathway before deployment;&nbsp;maintain&nbsp;the approved tool inventory with current risk classifications&nbsp; Manage vendor relationships, contract terms, and licensing decisions in coordination with Finance, Legal, and Procurement&nbsp; Stay ahead of capability shifts in the agent ecosystem and proactively surface opportunities.&nbsp; Governance, Risk &amp; Compliance&nbsp; Administer the AI Governance Framework: Approved Systems Registry, risk classification tiers, and&nbsp;GxP&nbsp;and non-GxP&nbsp;assessment pathways&nbsp; Ensure AI deployments meet applicable regulatory, privacy, and data integrity standards, and support audit readiness across&nbsp;GxP-adjacent environments&nbsp; Evolve governance controls as the&nbsp;tool&nbsp;landscape and regulatory environment change.&nbsp; Performance Measurement&nbsp; Define and own program success metrics, such as&nbsp;adoption rates, use case throughput, time-to-assessment, literacy baselines, and quantified efficiency gains by function&nbsp; Establish a reporting cadence to leadership and the Governance Committee with clear narrative on program ROI and risk posture&nbsp; Maintain a use case outcomes repository to capture lessons learned and&nbsp;identify&nbsp;replication opportunities across the organization&nbsp; Benchmark Apogee’s AI maturity against clinical-stage biotech peers and industry best practice to prioritize program investments&nbsp; Ideal Candidate &nbsp; Required&nbsp;&nbsp; 8+ years of progressive experience in digital strategy, enterprise technology, or AI program leadership; prior experience at a life sciences, biotech, or regulated healthcare organization strongly preferred&nbsp; Demonstrated ability to develop and execute AI or digital strategy in a matrixed, cross-functional environment&nbsp; Track record&nbsp;of building or operating AI governance, risk classification, or responsible AI frameworks&nbsp; Proven cross-functional leadership: ability to earn trust and drive outcomes across Cybersecurity, Legal, Clinical, and business functions without formal authority&nbsp; Hands-on familiarity with enterprise AI platforms, LLM-based tools, and agentic frameworks, including policy administration and access controls&nbsp; Strong executive communication and presentation skills; ability to&nbsp;advise&nbsp;senior leadership with clarity and&nbsp;appropriate precision&nbsp; Demonstrated change management capability across organizations with varied adoption readiness&nbsp; Preferred&nbsp; Direct experience in a clinical-stage or late-phase biotech or pharma environment, with working knowledge of&nbsp;GxP, 21 CFR Part 11, Annex 11, or comparable frameworks&nbsp; Familiarity with agentic AI architectures and multi-tool orchestration in enterprise environments&nbsp; Consulting background (Big 4 or strategy firm) with experience managing multi-stakeholder programs and external delivery partners&nbsp; Working knowledge of FDA AI/ML guidance, EU AI Act, or NIST AI RMF as they apply to enterprise or clinical AI deployment&nbsp; Behavioral Competencies&nbsp;&nbsp; Strategic yet pragmatic; able to start from&nbsp;a&nbsp;new&nbsp;environment&nbsp;and design a phased, realistic roadmap.&nbsp; Excellent communication and storytelling skills, capable of framing data and platform decisions in business terms for clinical and executive stakeholders.&nbsp; Demonstrated ability to lead through influence, collaborating effectively with integration, infrastructure, security, QA, and business teams without direct reporting lines.&nbsp; High ownership and bias for action, comfortable operating in a fast-paced, high-growth clinical-stage biotech environment.&nbsp; Interest in eventually building and leading a small data team, while being fully comfortable as a hands-on individual contributor in the near term.&nbsp; Other Requirements&nbsp; Ability and willingness to travel up to&nbsp;20%&nbsp;&nbsp;&nbsp; The anticipated salary range for candidates for this role will be $225,000-$250,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, AI Enablement

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Director, IT Quality &amp; Compliance to serve as the primary IT business partner for Apogee’s Quality organization while owning the company’s IT compliance and validation function. This role sits at the intersection of IT and Quality: managing Veeva Vault Quality as the IT system owner, authoring computer system validation (CSV) scripts and protocols in partnership with QA, driving inspection readiness from the IT side, operationalizing AI governance compliance, and maintaining the IT policy library and vendor risk program. This role reports to the Senior Director of Digital Strategy &amp; Enterprise Architecture.&nbsp; Key Responsibilities Quality IT Business Partnership Serve as the dedicated IT business partner for the Quality organization; develop a deep understanding of QA processes, priorities, and roadmap to&nbsp;anticipate&nbsp;and address IT needs proactively Own Veeva Vault Quality (QualityDocs&nbsp;and associated modules) as the IT system owner: manage system configuration, user administration, release management, and enhancement delivery in partnership with QA stakeholders Translate Quality business requirements into system enhancements, workflow changes, and configuration updates; manage the enhancement backlog and release cycle in coordination with QA and vendors Advise&nbsp;Quality on system risk, compliant use of technology, and IT implications of process changes; serve as a trusted technical advisor on how systems can best support quality operations Participate in QA planning meetings and strategic initiatives to ensure IT capabilities and constraints are represented from the outset&nbsp; Computer System Validation (CSV) Author validation scripts, test protocols, and supporting documentation (IQ/OQ/PQ) for&nbsp;GxP-regulated systems including Veeva Vault, SAS Validated Cloud, Egnyte&nbsp;GxP, and validated MuleSoft integrations; partner with QA for&nbsp;CSV&nbsp;review and approval Assess system changes for validation impact; manage change control documentation and ensure validated systems are&nbsp;maintained&nbsp;in a compliant state following changes Conduct and document periodic reviews of validated systems; manage decommissioning procedures in line with regulatory requirements&nbsp; Inspection Readiness &amp; IT Compliance Own&nbsp;IT inspection readiness across the validated systems portfolio. Partner with QA to ensure IT systems and electronic records meet 21 CFR Part 11 and&nbsp;other regulatory&nbsp;requirements; lead IT response to inspection findings and drive remediation to closure Maintain audit-ready evidence packages for&nbsp;GxP&nbsp;systems: audit trail integrity, access control records, system configuration documentation, and change history Own the IT policy library: author, version, and&nbsp;maintain&nbsp;SOPs and policies covering electronic records, audit trails, access control, change management, data classification, and AI use Develop and deliver IT compliance training;&nbsp;maintain&nbsp;training records in validated learning management infrastructure&nbsp; Vendor Risk Management&nbsp; Manage&nbsp;the IT third-party risk management program: vendor tiering,&nbsp;GxP&nbsp;qualification assessments, data handling reviews, and ongoing oversight for technology suppliers and SaaS providers. Evaluate&nbsp;new technology&nbsp;and AI vendors against Apogee’s governance framework prior to onboarding; coordinate security assessment inputs with the Director of Cybersecurity&nbsp; Ideal Candidate Required 8+ years of experience in IT quality systems,&nbsp;GxP&nbsp;IT compliance, or computer system validation in a regulated life sciences environment (biotech, pharma, or medical device) Demonstrated experience as an IT business partner or system owner for a Quality organization; deep familiarity with quality processes including document control, change control, CAPA, training, and deviation management Hands-on experience administering and configuring Veeva Vault Quality (QualityDocs&nbsp;required;&nbsp;additional&nbsp;modules such as QMS, Training, or RIM a plus) Hands-on experience authoring IQ/OQ/PQ validation scripts and protocols for&nbsp;GxP-regulated SaaS and cloud-hosted systems; comfortable working in a model where QA holds approval authority Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and ICH standards as applied to IT systems Experience with inspection readiness and serving as an IT representative during FDA or EMA regulatory audits Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field&nbsp;required; advanced degree or certifications (GAMP, CISA, Veeva Vault certifications) a plus Preferred Familiarity with AI governance frameworks or AI/ML compliance considerations in a regulated environment Experience building or contributing to a&nbsp;Third party&nbsp;risk management&nbsp;program, including&nbsp;GxP&nbsp;vendor qualification Experience&nbsp;validating&nbsp;modern data platforms (Databricks, Snowflake, or equivalent) in a&nbsp;GxP&nbsp;context Background in clinical-stage biotech navigating&nbsp;Phase 3 and&nbsp;commercial readiness. Behavioral Competencies Strong relationship-building skills; able to&nbsp;operate&nbsp;as a trusted partner to Quality leadership while&nbsp;maintaining&nbsp;IT rigor and objectivity Detail-oriented with strong documentation discipline; able to produce audit-ready deliverables under time pressure Comfortable operating at the intersection of regulatory, technical, and business domains with competing priorities High ownership and bias for action in a fast-paced, high-growth clinical-stage biotech environment Other Requirements Successfully&nbsp;exhibit&nbsp;Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 20% &nbsp; The anticipated salary range for candidates for this role will be $220,000-$245,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, IT Quality & Compliance

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary Apogee Therapeutics is seeking an Associate Director, Device Development to join the Technical Operations team to provide technical leadership in developing first class patient-centric biologic/device combination products for Apogee’s programs. Products include prefilled syringes with needle safety device and autoinjectors. As a technical leader in an emerging company relying on a fully outsourced supply chain, the Associate Director, Device Development will act as a subject matter expert (SME) in biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This position will work closely with external suppliers, manufacturers and with other functional areas in Technical Operations and Quality to ensure development and manufacture of high-quality combination products to support clinical supply, commercial manufacturing and regulatory submissions. Key Responsibilities Technical lead on cross-functional teams responsible for development of combination products Work with Quality function to develop and refine the combination product quality management system Author product-specific Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development Verification plans, protocols, and reports Oversee test method development, test method validation and design verification at external labs Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies for Design and Development Validation Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents Support person-in-plant during manufacturing at CMOs, as needed Serve as technical SME in root cause analysis and deviation investigations Author, review, and approve development studies and technical reports Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs Serve as technical SME on due diligence and business development opportunities Communicate findings and progress through presentations and reports Author and support regulatory submissions (IND, IMPD, amendments, BLA, etc.) Ideal Candidate Minimum 10 years of relevant industry experience, BS in mechanical engineering, biomedical engineering, chemical engineering or a related field required, advanced degree a plus Must have hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector. Experience should include: Development of User Requirements and Design Input Requirements Establishing statistical acceptance criteria based on reliability and confidence intervals Statistical analysis of test data Test Method Validation Design and Development Verification plans, protocols, and reports Design and Development Validation and Design and Development Transfer Process Validation Experience in late phase clinical development and commercialization of combination products Must have sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21 CFR Part 4, 21CFR820.10/ISO 13485 Experience working with external device suppliers, CMOs and cGMP manufacturing facilities Experience performing risk management per ISO 14971 Experience with execution of root cause analysis and investigations Strong communication and presentation skills Availability to participate in calls across multiple international time zones Ability to travel up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year as well as domestically and internationally to vendor / CDMO sites Ability to work independently and multi-task in a fast-moving organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless The anticipated salary range for candidates for this role will be $180,000 - $200,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Device Development

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;&nbsp;Role Summary&nbsp; Apogee Therapeutics is seeking an experienced Clinical Scientist for an Associate Director, Clinical Development (non-MD) role supporting the scientific planning and execution of one or more clinical studies in dermatology. This individual will partner closely with the Medical Director and cross-functional study team to support the planning, implementation, execution, monitoring, and interpretation of clinical studies to advance the development of innovative dermatology clinical trials. This role is highly collaborative and execution-focused and will involve close partnership with Clinical Operations, Biostatistics, Data Management, Medical Writing, Regulatory Affairs, and Medical Affairs to ensure successful delivery of clinical development objectives. &nbsp; Key Responsibilities&nbsp; Monitor clinical trial conduct for quality, safety, protocol compliance, and data integrity Perform ongoing review and interpretation of emerging clinical trial data, including safety, efficacy, and operational trends Collaborate cross-functionally to develop and review key clinical documents including protocols, informed consent forms, investigator brochures, clinical study reports, medical monitoring plans, safety narratives, and scientific presentations Collaborate with Data Management and Biostatistics to support data review, data cleaning activities, database locks, and validation of data collection tools Partner closely with Clinical Operations and CRO partners to support site management, enrollment and retention strategy, issue escalation, and study execution Develop strong working relationships with investigators, study coordinators, and key external stakeholders Stay current on scientific and clinical developments in atopic dermatitis and immunology to support competitive awareness and strategic planning Support inspection readiness activities and ensure compliance with GCP and applicable regulatory requirements &nbsp; Ideal Candidate&nbsp; Advanced degree in life sciences (e.g., PhD, PharmD, APNP, DVM, or equivalent clinical/scientific training) Minimum 5+ years of relevant clinical research experience, including biotechnology or pharmaceutical industry experience in Clinical Development Prior experience supporting clinical trials in immunology, dermatology, or atopic dermatitis preferred Strong understanding of clinical trial conduct, safety review, data interpretation, and cross-functional study execution Ability to analyze and interpret complex clinical data and communicate findings clearly Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment Excellent communication, presentation, and technical writing skills Proven ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders Working knowledge of GCP and global clinical trial regulations Demonstrated alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless Approximately 25% travel required (may include both US and international travel), including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, site visits, and medical congresses &nbsp; The anticipated salary range for candidates for this role will be $180,000-$210,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Clinical Development (Clinical Science) – Immunology

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;&nbsp; Key Responsibilities Clinical Support Collaborate with the clinical study teams to provide medical and scientific support for clinical sites Key Opinion Leader (KOL) Engagement: Develop and maintain strong relationships with clinical study investigators, key opinion leaders, and other external stakeholders in the field of dermatology Act as a credible, scientific resource for KOLs, providing them with up-to-date and relevant information on Apogee’s development programs Stay abreast of the latest developments, publications, and research in dermatology to effectively communicate with experts in the field Stay informed of competitor products and market trends in dermatology &nbsp; Internal Collaboration Work closely with cross-functional teams, including Medical Affairs, Clinical Development, Clinical Operations, and Business Development &amp; Strategy to ensure strategic alignment Provide insights and feedback to internal teams based on interactions with external stakeholders &nbsp; Ideal Candidate MSL : 2+ years relevant experience as outlined below Sr. MSL: 5+ years relevant experience as outlined below. In addition to the ideal MSL criteria outlined below, a Senior MSL candidate would bring established KOL relationships, demonstrated strategic territory engagement planning, experience supporting clinical trials, and a track record of leading multiple projects and congress initiatives. They would also serve as a peer leader and mentor, and exhibit intentional, cross-functional collaboration. Advanced degree in a relevant medical or scientific field (MD/DO, PharmD, PhD, MS or equivalent) Expertise in medical dermatology, specifically, atopic dermatitis preferred Strong understanding of clinical study execution and appropriate interactions with clinical study sites Knowledge of compliance requirements related to medical affairs activities and appropriate interactions with healthcare professionals Knowledge of the dermatology therapeutic area and current treatment paradigms in inflammatory skin diseases Excellent communication and presentation skills Ability to build and maintain relationships with key opinion leaders and healthcare professionals Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 75% travel across the territory, including mandatory attendance at All Hands meetings typically held twice per year, as well as regular travel to meet with clinical study site personnel and KOLs and to attend scientific conferences in the US and internationally, etc. Candidate must reside in the territory &nbsp; &nbsp; &nbsp; The anticipated salary range for candidates for this role is: MSL: $210,000 - $230,000 per year Sr. MSL: $230,000 - $250,000 per year The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp;&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Science Liaison Dermatology - Northeast

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary The Department of Research and Translational Medicine is seeking an Associate Director, Biomarker Development. This person will lead the development of biomarker strategies and execution for clinical development of programs in inflammatory and immune indications across the Apogee development pipeline. Key Responsibilities In this role, you will work across functions in Translational Research and Clinical Biomarkers to design, prioritize and execute biomarker strategies for clinical programs in I&amp;I indications. Distil and communicate biomarker plans, rationale, concepts and findings to internal stakeholders at appropriate levels for different audiences. Ability to execute in a highly matrixed model where strong communication and partnership skills are critical to success. Work closely with clinical operations, biomarker operations, medical and clinical development leads in driving the program to the clinic including finalization of lab manuals by providing input to specimen handling, collection, shipping and storage guidelines, set up sample testing timelines and oversee data transfers. Lead the development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics-based tools for inclusion in clinical trials. Partner closely with Biomarker Operations and Biomarker Laboratory members to drive optimization and execution of assays. Collaborate with Research, Biomarker Lab team and Biomarker Operations to assess method feasibility and supervise assay transfer to CROs; design and oversee experiments to troubleshoot assay performance issues. Establish relations with CROs, or academic laboratories, to execute biomarker strategy, monitor assay development including qualification/validation and biomarker testing in clinical trials to ensure high quality biomarker data. Analyze and interpret biomarker data generated across multiple platforms, in conjunction with biostats and computational biologists, to provide guidance on program impact and next steps. Contribute to biomarker sections of all regulatory documents; including INDs and BLAs, clinical protocols, clinical study reports, and other study related documents. Author and present biomarker data to internal and external scientific community, including press releases, posters and publications, to articulate the “why” and the “so what” behind the biomarker deliverables. Collaborate with Research function and Computational Science to facilitate reverse translation of clinical biomarker data for hypothesis generation and new target identification. Ideal Candidate PhD with &gt;8 years of pharmaceutical/biotech industry experience. With&gt;4 years in a translational role. Experience in Inflammation &amp; Immunology therapeutic area. Extensive experience in clinical biomarker strategy and execution, deep understanding of drug development stages and role for biomarkers. Adaptable approach with good problem-solving skills. Able to pivot in response to real world problems and data driven findings. Highly experienced in leading and collaborating effectively as a member of cross-functional teams, excellent communication skills to proactively drive projects and manage timelines and present to a variety of stakeholders and tailor message accordingly. Familiar with flow-cytometry based assays, genomics and protein (LBA) tools to lead biomarker discovery and development. Enjoys a fast-paced environment, flexible, able to manage multiple and competing priorities under tight timelines. Strong project management and time management skills required. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory attendance at All Hands meetings typically held twice per year and other workshops or conferences The anticipated salary range for candidates for this role will be $190,000-$210,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Biomarker Development

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary &nbsp; We are seeking a Medical Director to oversee clinical execution and medical monitoring of dermatology studies. As part of a growing clinical development team, you will be responsible for seamless execution of studies and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitor activities. If you thrive in a fast-paced environment and seek the opportunity to advance clinical programs into later stages of development this role is for you! Key Responsibilities&nbsp; Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan Support the design of trials and develop protocols and other relevant documents for individual studies Support start-up activities related to assigned studies Oversee day-to-day clinical and medical execution of studies Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan Partner with clinical operations on site selection, recruitment, and CRO management Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable Ideal Candidate&nbsp; Education – MD is required Experience in clinical development in dermatology, allergy, immunology or rheumatology preferred 2+ years’ industry experience as a medical monitor and/or medical director preferred Experience working on phase 2 and 3 clinical studies preferred Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 20% travel including mandatory in-person attendance at All Team meetings typically held twice per year, functional meetings, study-related activities, and medical conferences The anticipated salary range for candidates for this role will be $290,000 to $330,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Director - Dermatology

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary We are seeking a Medical Director, Pharmacovigilance to join the Apogee Clinical Development team. In this newly created position, you will be responsible for safety aspects across Apogee’s pipeline. This role is critical in supporting regulatory approvals, patient safety, and long-term safety input into life-cycle management. Additionally, you will play a key role in supporting drug safety and pharmacovigilance activities to ensure high-quality data generation to support the safety and efficacy of our products in development. &nbsp; Key Responsibilities Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways. Contribute to the development and execution of pharmacovigilance strategies for Apogee clinical programs across various stages of development. Maintain ongoing benefit–risk assessments incorporating disease severity, unmet medical need, and emerging clinical data. Collaborate with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries. Ensure high-quality MedDRA coding, appropriate event characterization, and robust safety narratives. Lead preparation and review of DSURs, Investigator’s Brochures (IBs), safety sections of protocols, informed consent forms (ICFs), and clinical study reports. Provide safety input to regulatory submissions (INDs/CTAs), protocol amendments, and responses to health authority inquiries. Partner with Regulatory Affairs and Quality teams to address safety findings, deviations, and corrective and preventive actions (CAPAs). Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing. Support the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA)/Biologics License Application (BLA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards. Review safety content of scientific publications such as posters, abstracts, and manuscripts. &nbsp; Ideal Candidate MD degree is required Minimum 8 years of pharmacovigilance experience in the biopharmaceutical industry Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH) Exposure to biologics, medications for I&amp;I conditions including dermatology and respiratory indications a plus Experience in late-stage development and submissions Alignment with Apogee C.O.R.E. (Caring, Original, Resilient and Egoless) values Position requires up to 20% travel including mandatory in person attendance at All Hands meetings typically held twice per year, team meetings, conferences, etc. &nbsp; The anticipated salary range for candidates for this role will be $285,000 to $330,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Medical Director Pharmacovigilance

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary The Department of Research and Translational Medicine is seeking an Associate Director, Biology. Reporting to the Director of I&amp;I Biology, this individual will lead and mentor a team of scientists in the Research and Translational Medicine department, providing scientific leadership for studies defining antibody mechanisms of action (MOA) and target biology. Key Responsibilities Apply deep expertise in biology and pharmacology to provide strategic scientific vision and guide therapeutic I&amp;I biology research across atopic dermatitis, allergic asthma, EoE, and other I&amp;I indications. Design, develop, and oversee disease-relevant and complex in vitro and ex vivo models using multiple primary human cell types to evaluate the mechanism of action of Apogee antibodies and target biology. Contribute to authoring and reviewing regulatory submissions and publications. Manage and coordinate projects (in-house &amp; CRO) to ensure adherence to timelines and goals. Establish and promote laboratory best practices. Analyze and interpret complex data from studies to inform on program decisions and effectively communicate outcomes and recommendations to the research group and senior leaders. Collaborate with scientists across functions to generate high-quality data supporting programs from discovery through development. Ideal Candidate Ph.D. degree and a minimum of 8 years of scientific/technical experience. Broad understanding of I&amp;I disease biology (atopic dermatitis, asthma, and EoE) and underlying disease mechanisms is required and familiarity with inflammatory cytokine/chemokine networks is strongly preferred. Hands-on expertise developing and validating complex in vitro and ex vivo functional models using disease relevant cell types Proficiency with analysis of large, cross-platform data sets and assay platforms such as ELISA/MSD, flow cytometry, and cytokine/mediator release assays to characterize and advance therapeutic antibodies and target biology. Ability to manage multiple projects with competing timelines and shifting priorities simultaneously. CRO management experience including evaluation of new CROs&nbsp;is desired. Experience managing and developing junior scientists. BEHAVIORAL COMPETENCIES Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Skilled in verbal and written communication in formal and informal settings Self-driven, team-oriented mindset OTHER REQUIREMENTS Ability and willingness to travel 6 times per year for All Hands meetings, team offsite meetings, and conferences Ability to work onsite in the Apogee lab located in Boston, MA four days per week The anticipated salary range for candidates for this role will be $185,000 – $205,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Inflammation Biology

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp; Role Summary Review clinical trial synopsis and/or protocols to understand IMP supply and demand requirements. Assist in packaging and supply strategy development using Excel or SaaS based forecasting tools to maximize efficiency and minimize waste while maintaining a low risk profile. Coordinate with third-party vendors including packaging suppliers, distribution centers, freight forwarders, and courier services. Support domestic and international logistics for clinical studies by ensuring timely and compliant delivery across the supply network, monitoring shipment visibility, and helping resolve logistics deviations including delays, temperature excursions, and customs issues. Support the Demand &amp; Operations Planning (D&amp;OP) process across assigned studies in collaboration with Supply Chain Operations. Monitor and report inventory levels at depots and clinical sites through the life of a trial; alert supply lead to avoid potential supply issues. Assist in developing requests for proposals for packaging, labeling, storage, and distribution. Review vendor invoices and provide input for accruals and budget tracking as applicable. Support vendor performance monitoring and governance reporting. Ensure supply chain activities adhere to GMP, GDP, and applicable regulatory guidelines (FDA, EMA, ICH). Contribute to the development and maintenance of SOPs and work instructions to support operational excellence. Support regulatory inspections and audits through thorough documentation and record-keeping. Participate in cross-functional project teams and contribute to continuous improvement initiatives. Ideal Candidate B.S. in Supply Chain Management, Life Sciences, Engineering, or a related field with 6+ years of relevant experience in supply chain, logistics, or operations. Experience with inventory and supply chain management in a biotech, pharmaceutical, or clinical environment strongly preferred. Familiarity with GMP, GDP, and regulatory guidelines including ICH, CFR, and EMA standards. Experience with ERP systems, IRT, forecasting tools, or inventory management systems. Strong knowledge of Microsoft Office, including Excel and PowerPoint. Smartsheet experience is strongly preferred; PowerBI or Tableau is a plus. Knowledge of import/export requirements and experience with international logistics is a plus. Proven ability to manage multiple priorities, proactively identify and resolve issues with strong attention to detail and problem-solving skills. Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity. Excellent communication and collaboration skills with the ability to work effectively across functions. BEHAVIORAL COMPETENCIES Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless OTHER REQUIREMENTS Ability and willingness to travel up to 15% domestically and internationally, including mandatory in-person attendance at All Hands and TechOps meetings typically held twice per year. The anticipated salary range for candidates for this role will be $115,000-$130,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. &nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Senior Specialist, Supply Chain Management

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking a motivated and experienced Associate Director, Scientific Communications to serve as a key partner in the development and execution of Apogee’s scientific communications strategy across the dermatology, respiratory, and GI therapeutic areas. The ideal candidate will have broad Scientific Communications experience, including medical congress booth execution, publications development, medical communications material development, and strategic and tactical planning. The ideal candidate will also demonstrate strong scientific acumen, be adept at cross-functional and external stakeholder collaboration, have strong scientific writing skills, and demonstrate proficiency in project management. Key Responsibilities As an Associate Director of Scientific Communications at Apogee Therapeutics, you will be responsible for shaping and executing a strategic scientific communications plan that drives impactful communication of Apogee Therapeutics’ data across the lifecycle of our assets. Key responsibilities include: Planning and executing medical congresses, including abstract and presentation development, booth design and build coordination, on-site logistics, and pre/post-congress communications to ensure a compelling and compliant scientific showcase. Supporting development and execution of the scientific communications plan, including publications planning, field medical materials, manuscript and abstract coordination, and vendor management. Owning the strategic scientific communication plan for one or more therapeutic areas or geographies. Managing end-to-end Medical/Legal/Regulatory (MLR) review of medical communications materials, including routing, comment reconciliation, version control, approvals, and archival in the MLR system of record. Collaborating with internal stakeholders across Medical Affairs, Clinical Development, Biostatistics and other functions to develop and disseminate scientific content that accurately reflects Apogee’s data. Managing external agency and medical writing vendor relationships for key projects to ensure quality, compliance, and on-time delivery. Contributing to additional scientific communications initiatives as the pipeline evolves and organizational needs shift. Ideal Candidate Advanced degree (Ph.D., M.D., Pharm.D., or equivalent). 5+ years pharmaceutical industry or agency experience with 3+ years specifically in a Scientific Communications and/or Publications role. Experience in the dermatology, respiratory, allergy, or GI therapeutic areas. Hands-on experience driving global medical congress execution, including booth planning and design, abstract/poster development, and on-site coordination. Experience in scientific publications management, including knowledge of conference abstract and poster and manuscript submission processes, peer review processes, and publications ethics. Strong working knowledge of compliance expectations for medical communications (e.g., scientific balance, appropriate references, claims support, intended use, and fair/balanced presentation). Excellent written and verbal communication skills, with a keen eye for detail and accuracy in scientific writing and editing. Knowledge of relevant publication best practices in industry (e.g., ICMJE, GPP, and COPE guidelines). Strong organizational and project management skills, with the ability to guide numerous projects simultaneously and plan proactively. Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless This position requires up to 20% travel, including a minimum of 2 times per year for All Hands meetings and ≥2 times a year for key scientific congresses. The anticipated salary range for candidates for this role will be $170,000 - $195,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Associate Director, Scientific Communications

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary The Director of Data Management and Systems (DM) is a strategic and operational leader with deep expertise in DM systems and data standards, responsible for scaling processes and ensuring high-quality, regulatory-compliant data delivery across a fast-paced clinical development environment. This role combines hands-on systems knowledge, vendor oversight experience, and the ability to lead cross-functional study teams ensuring high-quality, regulatory-compliant data delivery that supports timely decision-making and submissions. The Director is also responsible for overseeing end-to-end data management activities across one or more clinical development programs, bringing program-level leadership and operational discipline to ensure consistency, quality, and regulatory compliance across studies. The ideal candidate brings a balance of hands-on systems knowledge, vendor oversight experience, and program-level leadership, with a proven ability to scale processes in a fast-paced clinical development environment. Key Responsibilities Systems &amp; Technology Leadership Provide strategic and operational leadership for DM systems (e.g., EDC, ePRO/eCOA, RTSM, CTMS integrations). Lead selection, implementation, optimization, and governance of DM technologies and platforms to support scalable, high-quality data management across clinical development programs. Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches. Partner with Biostatistics, Programming, and IT to ensure seamless data flow and interoperability across systems. Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data quality and efficiency. &nbsp;Program &amp; Study Leadership Provide strategic leadership and oversight of DM activities across assigned clinical programs (Phases I–III and beyond). Serve as the DM lead on cross-functional program teams, influencing study design, timelines, and data strategy. Ensure delivery of high-quality, submission-ready datasets in alignment with program milestones. Proactively identify risks to data quality, timelines, or deliverables and implement mitigation strategies. Data Management Operations Oversee all DM deliverables including CRF design, database build, data cleaning, coding, and database lock. Establish and maintain data review strategies, including centralized monitoring and risk-based approaches. Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.). Drive inspection readiness and support regulatory submissions. Vendor &amp; Partner Oversight Provide strategic oversight of CROs and external data vendors. Define scope, KPIs, and performance metrics; ensure accountability and high-quality deliverables. Lead vendor selection and contract input for DM-related services. People Leadership &amp; Development Build, mentor, and lead a high-performing DM team. Foster a culture of accountability, innovation, and continuous improvement. Provide coaching and career development for team members. Process Improvement &amp; Innovation Develop and standardize DM processes, SOPs, and best practices. Drive initiatives to improve efficiency, scalability, and data quality. Lead or contribute to cross-functional initiatives related to data strategy and digital transformation. &nbsp;Ideal Candidate Bachelor’s degree in life sciences, computer science, or related field; advanced degree preferred. 12+ years of experience in clinical data management within biotech, pharma, or CRO environments. Experience in both operational DM and systems/technology implementation. Demonstrated leadership of DM activities across multiple clinical trials and programs. Technical Expertise Deep knowledge of EDC systems (e.g., Medidata Rave). Strong understanding of CDISC standards (SDTM, CDASH) and data lifecycle. Experience with data integrations, external data (labs, imaging, biomarkers), and decentralized trial technologies. Familiarity with data visualization and analytics tools is a plus. Leadership &amp; Competencies Proven ability to lead cross-functional teams and influence at the program level. Strong strategic thinking with hands-on execution capability. Excellent communication and stakeholder management skills. Experience in fast-paced, growing organizations preferred. Ability to bridge systems/technology with clinical execution. Strong ownership mindset over data quality and delivery timelines. Proactive, solutions-oriented approach to complex data challenges. Effective leadership in ambiguity and evolving clinical landscapes. The anticipated salary range for candidates for this role will be $215,000 - $245,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Director, Data Management and Systems

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&amp;I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&amp;I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values:&nbsp;Caring,&nbsp;Original,&nbsp;Resilient and&nbsp;Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! &nbsp;Role Summary We are seeking a Therapeutic Area (TA) Head, Respiratory - Clinical Development. In this newly created position, you will be primarily responsible for developing and executing an integrated clinical development strategy and clinical trial programs in respiratory. In this leadership role, you will have the opportunity to guide and mentor a team of experienced Medical Directors and Clinical Scientists. As part of a growing Clinical Development organization, you will be responsible for providing clinical expertise, obtaining scientific advisory input from external experts, working cross-functionally to develop clinical studies, leading clinical aspects of regulatory interactions for product advancement, and partnering with the clinical operations team to provide medical and strategic input to achieve operational excellence. The TA Head will have expertise in respiratory disease, have demonstrated effective collaborative skills to work across various phases of clinical development with an emphasis on later stages (phase 2 and beyond), and serve as a medical expert for multiple cross functional teams. Building relationships with Investigators is essential for this role including meeting with sites to foster collaboration and training. Apogee offers a dynamic, fast paced and highly collaborative approach to drug development. The Therapeutic Area Head will oversee programs across the respiratory portfolio. The position reports to the SVP, Head of Clinical Development. Key Responsibilities Build, lead and mentor a team of Medical Directors and Clinical Scientists focused on Apogee’s respiratory portfolio, including monotherapy and combination therapies Apply expertise in the treatment and management of respiratory conditions to advance the strategy and clinical development of Apogee’s medicines for the benefit of our patients Work cross-functionally with Program Leadership/Management, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research &amp; Translational Medicine, Commercial and other functions to develop the overall clinical development strategy in respiratory indications Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to execute and successfully complete clinical trials across development phases leading to BLA filings and approvals Help establish and maintain a network and relationships with respiratory experts, investigators and opinion leaders Contribute to the scientific communication strategy of Apogee Therapeutics via publications, manuscripts, abstracts, posters and scientific presentations Participate in medical review of adverse event reports and monitoring of incoming safety data in collaboration with pharmacovigilance, including evaluating and escalating safety signals Coordinate and develop information for reports submitted to FDA, EMA, PMDA and government, regulatory, or partner agencies Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and key opinion leaders Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review Review and edit clinical study reports Ideal Candidate Board certified MD with expertise in respiratory and/or immunology drug development and experience across later stages of clinical development 10+ years' biotech or pharmaceutical industry experience in a leadership role building and mentoring clinical development teams (MDs and non-MDs) Passion for bringing better treatment options to patients and caregivers Knowledge of clinical development strategies and trial execution for biologics and immunology therapeutics in the US and globally Self-starter who will bring expertise and inspiration to the team, is able to multi-task in support of clinical development programs and has a growth mindset Leads and works collaboratively with cross-functional teams in a fast-paced, hands-on and dynamic environment Strong leadership, communication and presentation skills Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires approximately 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as team meetings, medical conferences, etc. The anticipated salary range for candidates for this role will be $395,000 to $425,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.&nbsp; What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve &nbsp; E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. &nbsp; Apogee Therapeutics is proud to be an Equal Opportunity&nbsp;employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. &nbsp; To review our privacy policy, click here &nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. &nbsp;

Sunland Park Assistant Manager

Your career is worth investing in.

Get unlimited referrals with Premium.