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 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 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;

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