Spyre Therapeutics is a cutting-edge biotechnology company specializing in developing innovative therapies for a wide range of diseases. Founded in 2010, the company has been at the forefront of revolutionizing the healthcare industry with its groundbreaking research and development efforts. Spyre Therapeutics' commitment to advancing medical science has led to the creation of novel treatments that have the potential to significantly improve patient outcomes and transform the standard of care.

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As Associate Director, Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for medical writing strategy and timely deliverables for one or more projects or programs. You will be responsible for authoring clinical, nonclinical and regulatory documents. You may be responsible for oversight or general assistance to medical writing consultants and other writers.&nbsp;You will collaborate with cross-functional subject matter experts (SMEs) to meet aggressive timelines. You will project manage high-quality documents and/or submissions from start to finish, develop strong relationships, and be an advocate for best practices in Medical Writing. Key Responsibilities: Lead projects, submissions and documentation for programs independently. Collaborate with manager and other functions on planning and appropriate resourcing.&nbsp; Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met.&nbsp; Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses.o &nbsp; &nbsp;Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable.o &nbsp; &nbsp;Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).&nbsp;o &nbsp; &nbsp;Coordinate QC, finalization and publication of documentso &nbsp; &nbsp;Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required.&nbsp;o &nbsp; &nbsp;Ensure key messages are clear and consistent across and within documents.&nbsp; Represents the medical writing function in cross-functional teams. Provide status updates to keep teams, department, and leadership informed. Identify risks and contribute to risk mitigation or contingency planning for submission activities.&nbsp; Possible oversight of contract medical writers, ensuring high-quality documents delivered and timelines met.&nbsp; Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials. Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.&nbsp; Ideal Candidate: Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus.&nbsp; A minimum of 8+ &nbsp;years of experience in relevant regulatory medical writing is required.&nbsp; Proven track record of program- and/or submission-level management Ability to manage multiple projects and timelines simultaneously Proven track record of leading and authoring high-quality clinical and regulatory documents, including for complex document types. Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements. &nbsp; Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus.&nbsp; Excellent leadership, collaboration, communication, and interpersonal skills (taking initiative, problem solving, conflict resolution, change management, strategic thinking).&nbsp; Ability to meet deadlines and adapt to changing priorities.&nbsp; Expert in word processing software (e.g., Office) and document management systems (e.g., Veeva). What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $175,000 to $200,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Associate Director, Medical Writer

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Executive Director of Program Management will play a crucial role in the planning and execution of our development programs. This position requires a proactive individual who thrives in a dynamic, rapidly growing startup environment. Key Responsibilities: Meticulously maintain and track detailed integrated program timelines ensuring alignment across functions on dependencies and assumptions crucial for corporate goals. Recognize and alert stakeholders when projects are on or near critical paths to key milestones. Communicate progress transparently and address issues promptly. Manage cross-functional meetings efficiently, ensuring clear objectives, documenting outcomes, information, and action items, and following up on tasks with team members.&nbsp; Develop and upkeep project documentation including meeting materials, minutes, action item logs, decision trackers and dashboards. Proactively identify, monitor, communicate and propose mitigation options for program risks.&nbsp; Collaborate across functions including Pre-clinical, Clinical Development, Technical Operations, Regulatory, Quality, Finance and Legal to ensure alignment. Play a pivotal role within the Portfolio Management and Operations team, providing guidance on best practices, developing team resources, tools and templates, and nurturing a culture of excellence, innovation, and accountability. Other duties as assigned Ideal Candidate:&nbsp; &nbsp;&nbsp; Demonstrated proficiency in overseeing complex development programs, guiding them from Investigational new Drug IND) stage through Phase 2 clinical development, with a strong preference for monoclonal antibody therapeutics experience. Bachelor’s degree in a science-related field required; an advanced degree is preferred. Minimum of 10 years of relevant experience in biotechnology or pharmaceuticals, with at least 5 years directly in program management. Strong planning skills, critical thinking abilities and keen attention to detail. Ability to juggle multiple tasks, adapt to shifting priorities in a fast-paced environment. Excellent facilitation, communication, and leadership skills Strong interpersonal skills and the ability to interact well with all employee levels Expert in creating Gantt charts in Smartsheet, Think-Cell and Office Timeline Pro+ software, along with report generation. In-depth understanding of the drug development process, regulatory requirements, and industry standards. Willingness to travel up to 10% annually, including quarterly all hands meetings and ad hoc development team gatherings. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $295,000 to $313,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Executive Director, Program Management

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: We are seeking an analytical and detail-oriented individual, who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols, leading design and review of case report forms, assisting with development and validation of clinical databases and systems, and performing all data management related activities. &nbsp; Key Responsibilities: Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival Conduct oversight of and provide guidance to data management CROs to ensure that data management documents and tasks are completed and delivered in accordance with timelines and data quality standards Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.) Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA) Coordinate cross functional data review and provide proactive review of data trends and issue resolution Other duties as assigned Ideal Candidate: Bachelor’s degree is required. 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry, with 5-8 years as a Lead Data Manager. Hands-on knowledge and experience in data management activities, such as CRF and EDC design, review, and validation of data from various vendors Knowledge of real-time data flow across clinical systems Strong knowledge of EDC systems (Medidata Rave, Veeva, or equivalent) Knowledge of GCP, ICH, and regulatory requirements Successful track record of working independently in a matrixed organization or in a start-up environment and providing effective solutions to emerging problems Excellent interpersonal communication skills, along with organizational skills What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $170,000 to $186,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Manager, Data Management

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Director, Drug Product Clinical Supply Chain is a senior leadership role within Technical Operations responsible for the end-to-end strategy, execution, and continuous improvement of clinical drug product supply across global development programs. This role ensures uninterrupted, compliant supply of drug product from formulation through packaging, labeling, release, and distribution, while building scalable capabilities to support clinical development towards commercial launch. The Director serves as the primary drug product supply chain leader for one or more global clinical programs and partners closely with CMC, Quality, Regulatory, Clinical Operations, Finance, and executive leadership, as well as external CMOs and vendors. Key Responsibilities: Strategic Drug Product Supply Leadership Own the global clinical drug product supply strategy for assigned programs, ensuring alignment with clinical development timelines, regulatory requirements, and corporate objectives. Lead end-to-end clinical supply planning and execution to ensure uninterrupted, on-time, and compliant delivery of drug product throughout global clinical trials. Provide strategic direction for scaling drug product supply capabilities from Phase 2 through Phase 3 and commercial readiness. Clinical Supply Chain &amp; Operations Oversight Direct all clinical drug product supply chain activities, including demand forecasting, supply planning, IRT support, labeling strategy, packaging and labeling operations, release, distribution, inventory management, expiry strategy, and cold chain oversight. Establish and maintain robust processes, systems, and controls to ensure compliance with GMP, GDP, and global regulatory requirements. Perform short-, medium-, and long-term supply forecasting and oversee monthly forecasting and production planning cycles. Drug Product Technical Operations Provide senior technical oversight of drug product formulation, manufacturing, packaging, and labeling activities conducted by external CMOs. Evaluate and implement new technologies, systems, and delivery approaches to improve supply robustness, efficiency, and scalability. Ensure technical and supply chain readiness for regulatory submissions and inspections. Vendor &amp; Partner Leadership Lead CMO and vendor strategy, including selection, contracting, performance management, change control, and issue resolution across all outsourced drug product supply activities. Oversee procurement of comparator drug products and matching placebo, as required. Build strong, performance-driven partnerships with external vendors to support clinical and future commercial needs. Quality, Compliance &amp; Continuous Improvement Provide leadership oversight of quality-related activities impacting clinical drug product supply and participate in quality improvement initiatives. Serve as a senior subject matter expert in clinical supply GMP, GDP, and related business processes. Proactively identify risks, trends, and opportunities for continuous improvement across drug product technical operations and supply chain processes. Documentation, Budget &amp; Cross-Functional Leadership Author, review, and approve clinical and technical documentation, including clinical labels, packaging batch records, protocols, pharmacy manuals, and regulatory submissions (IND, IMPD, NDA). Own clinical drug product supply budgets for assigned programs, ensuring accurate cost forecasting and alignment with inventory and demand strategies. Act as a key cross-functional leader, providing clear communication, decision-making, and guidance to internal teams and senior management. Other duties as assigned Ideal Candidate: Bachelor’s degree or advanced degree in a scientific, engineering, or related discipline. 10+ years of experience in pharmaceutical or biotech drug product technical operations and clinical supply chain, with demonstrated leadership responsibility. Proven experience leading global clinical drug product supply for complex Phase II/III randomized, I&amp;I and/or IBD clinical trials.&nbsp; Strong working knowledge of GMP, GDP, GCP, and global import/export regulations related to clinical drug product supply. Demonstrated success managing complex, outsourced drug product supply chains and CMO relationships. Strategic mindset with strong analytical, problem-solving, and decision-making capabilities. Excellent communication and leadership skills with the ability to influence cross-functional teams and senior stakeholders. Experience in a small or emerging biotech environment preferred. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Drug Product & Supply Chain

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Director, Clinical Operations, is a pivotal role responsible for executing the clinical operational strategy to ensure that all clinical development activities within the company are conducted efficiently to agreed corporate timelines and in compliance with local and global requirements. You will support the clinical team with the implementation and oversight of clinical trials, focusing on the areas of clinical operational strategy, trial logistics planning, enrollment, site monitoring, data quality, and study reporting. This role will be the critical interface between Sponsor, CRO, and team at study sites. Key Responsibilities: Direct input into the clinical operational strategy and plans. Implementation and management of the clinical operational plans and programs to meet corporate goals and objectives. Work with Clinical Development to draft clinical trial protocols and other trial-related documents, and work with other departments and functions to implement clinical trial protocols. Serve as an interface with clinical investigators. Effectively negotiate contracts with consultants, clinical investigators, and contract research organizations. Conduct funding negotiations with clinical sites when necessary. Support the management of site-related activities, development of tracking tools, and manage recruitment timelines. Prepare updates on study progress. Prepare the study budgets, and track payment of contracts related to the project. Generate clinical department SOPs and conduct trainings as necessary. Regularly make presentations to senior staff members and participate in relevant Development Team meetings. Procure and oversee outside vendors and consultants as required. Supervise and manage activities of clinical operations personnel. Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials. Attend scientific and external training meetings as needed. Other clinical operations activities as required. Ideal Candidate: Bachelor's Degree is required. A minimum of 8 years of global clinical research experience within the pharmaceutical or biotechnology industry. Inflammation and/or Immunology experience is strongly preferred In-depth understanding and experience across clinical operations with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection. Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred. Ability to lead cross functional study teams in a growing and dynamic organization Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $215,000 to $238,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Clinical Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: Spyre Therapeutics is seeking an outstanding candidate to join our Quality team.&nbsp; The Manager, Quality Management Systems will contribute to maintaining Spyre’s Quality Management System in accordance with Spyre’s specific needs, regulatory requirements, and flexibility to support change and innovation. This role will drive establishment and improvements to GxP quality system and processes such as Document Control and Training, as well as the tracking/trending/reporting of Quality Metrics. This position will work closely with CMC, Clinical Development/Operations and Supply Chain functions. Key Responsibilities: Manage and maintain a compliant Document Control System (Veeva) Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product quality related documents) and archiving activities. Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for each function and reporting monthly metrics. Manage the processing of QMS items for Change Control, Deviations and CAPAs Generate Quality System metrics as per established timelines and assist in generating data for Quality Management Reviews. Work with document authors and reviewers to process documents. Oversee periodic document review process to ensure compliance with established review schedules. Onboarding/Offboarding employees and assigning training. Train and mentor users on the use of eQMS, process and procedures. Support Spyre functional groups as needed. Other duties as assigned Ideal Candidate: Bachelor’s degree in life sciences or a related field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality control/quality assurance functions. A combination of relevant education and experience may be considered. Experience with monoclonal antibodies is preferred. In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits. Experience in the use of Veeva electronic quality management systems (eQMS) (Veeva Vault or Veeva Quality Basics) required.&nbsp; Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously. Strong verbal / written communication and presentation skills with the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations. Demonstrated ability to work in a fluid, dynamic and fast-paced environment. Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $140,000 to $151,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Manager, Quality Systems

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: We are seeking an experienced Administrative Assistant (AA) to provide administrative support to our Sr. Directors/Directors and Sr. Managers.&nbsp;&nbsp;The ideal candidate must have direct experience supporting Directors and Manager.&nbsp;&nbsp;Working 100% remotely, the AA must possess clear, concise communication, be a self-starter, who is proactive, prioritizes tasks and enjoys taking on new assignments. Being flexible, curious, detail-oriented, accountable, and willing to learn is essential. &nbsp; Key Responsibilities: Provide administrative support for team&nbsp;members&nbsp;across the organization&nbsp; Schedule meetings&nbsp;to include both internal and external parties&nbsp; Coordinate and book international and domestic travel needs for team members Submit team expenses and credit card reconciliations in a timely manner and within our company’s policy&nbsp;&nbsp; Assist with meeting planning such as sourcing hotels, meeting space, conference registration and tracking tasks&nbsp;&nbsp; Assist with special projects such as all company events and offsites, onboarding/offboarding contractors and employees and contributing to our Admin SharePoint site&nbsp; Build strong cross-functional relationships and partner with other administrators to ensure a high functioning &amp; collaborative admin team environment Ideal Candidate: 2+ years’ related experience as an administrative assistant Bachelor’s degree and/or equivalent work experience Experience directly supporting Senior&nbsp;Directors/Directors, Sr. Managers/Managers is preferred Biotechnology industry strongly preferred Excellent communication skills, both written and verbal. Communicates clearly, concisely and in a highly professional and timely manner with all internal and external partners&nbsp; Experience managing and maintaining sensitive complex calendars of in-person, video, and external meetings across multiple global time zones, while working closely with teams and other EAs within the organization&nbsp; Exceptional time management and organizational skills with a strong attention to detail Proficient in Microsoft Office suite: Word, Excel, PowerPoint,&nbsp;Outlook&amp; Teams&nbsp;with the ability to learn&nbsp;new programs,&nbsp;such as SharePoint, Forms, RAMP and Concur for T&amp;E.&nbsp;&nbsp; Ability and willingness to travel up to 10% What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $ 80,000 to $99,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Administrative Assistant

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: We are seeking an experienced Executive Assistant (EA) to provide administrative support to senior executives (VPs and their teams) of Spyre. The ideal candidate will have direct experience supporting C-level executives, possess excellent communication skills, and excel in a dynamic, fast-paced environment. Working remotely, the EA must be a self-starter, who is proactive, anticipates needs, prioritizes tasks and enjoys taking on new projects. The candidate will be a strategic partner in coordinating, calendaring and arranging travel; team support; prioritizing workflow and completing various projects. Being flexible, adaptable and detail-oriented is essential. Key Responsibilities: Manage all administrative, logistical, and project-related tasks for SVP and VPs Partner and collaborate with Global Development Organization’s EA (GDO will have two EAs) Proactively and strategically manage complex calendars and schedule internal and external meetings,&nbsp;ensuring schedules match with the executive’s priorities Coordinate travel,&nbsp;which includes team offsites, medical conferences/congresses, and Scientific Advisory Boards Attend Global Development Organization Leadership Team meetings Track and manage expenses in Ramp Assist in managing contracts and other third-party vendor documents Assist with presentations, meeting materials or other departmental information, as needed Help onboard new team members and other activities, as required Build cross-functional relationships at all levels of the Company to ensure understanding of the business, leaders and workflow Collaborate and partner closely with other EAs regarding company-wide activities, cross-functional meetings, etc. Engage in company-wide culture team activities, including logistical support Provide ad-hoc support as requested to individuals across the Global Development Organization Leadership Team Demonstrate composure and flexibility, regardless of competing priorities Find new and efficient ways to create work processes to help maximize the executives' time Represent Spyre to external constituents Other duties as assigned Ideal Candidate: 10+ years’ related experience as an executive assistant Bachelor’s degree and/or equivalent work experience Experience directly supporting senior executives Biotechnology industry strongly preferred Exceptional interpersonal skills and considerable organizational savvy: capable of representing both Spyre and the “office” of the executives in a highly professional manner. Knows how to navigate internally to find the appropriate resources and contacts in an expeditious and effective manner Outstanding communication skills, both written and verbal. Communicates clearly, concisely and in a highly professional and timely manner with all internal and external partners Proven track record and experience handling highly confidential or sensitive information in a consistently appropriate and effective manner Experience managing and maintaining sensitive complex calendars of in-person, video, and external meetings across multiple global time zones, while working closely with senior leaders and other EAs within the organization Exceptional time management and organizational skills with a strong attention to detail Strong business and financial acumen: has an in-depth and thorough understanding of the business and its operations and is capable of performing more complex financial and/or other business analyses and reporting Highly proficient in Zoom, DocuSign, Concur and Microsoft Office suite: Word, Excel, PowerPoint &amp; Outlook, with the ability to learn new programs, as needed Ability and willingness to travel up to 20% What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $118,000 to $130,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Executive Assistant, Administration and Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As the Senior Manager, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities. You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents. Key Responsibilities: Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs. Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports. Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone. Device &amp; Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions. Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression. Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions. Other duties as assigned. Ideal Candidate: Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience). Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation. Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development. Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations. Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus. Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses. Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment. Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams. Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories). What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $150,000 to $175,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Manager, Regulatory Affairs CMC and Devices

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: We are seeking an experienced Associate Director, Supply Chain, to join our growing Technical Operations team. You will be responsible for developing and implementing clinical supply chain procedures and infrastructure to support the upcoming pipeline of projects. You will also be responsible for developing clinical supply chain strategies ensuring availability of supply through development and commercial launch, as well as transferring sustaining activities to the appropriate site planning. This individual also ensures uninterrupted supplies throughout the duration of a clinical study program based upon related targets and regulatory requirements in addition to providing CMO vendor oversight. Key Responsibilities: Lead a team to plan and deliver on-time, compliant clinical supply per the clinical development plan Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations Performs supply forecast modeling (short, medium and long-term) Ensures product requirements and costs for the budget are complete and in place for assigned projects Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions. Publishes monthly inventory reports for all products Oversees activities relating to the labeling, packaging, and distribution plans for each study based on protocol requirements and factors such as regulatory requirements, blinding concerns, ease of handling by the sites and patients, and patient compliance Manages the procurement of comparator drug products and matching placebo as required&nbsp; Other duties as assigned Ideal Candidate: Bachelor’s degree or advanced degree in scientific fields with 6+ years of experience in clinical supply chain and logistics Strong experience managing clinical supply activities for global phase 3, randomized, I&amp;I and/or IBD clinical trials Working knowledge of import and export laws and processes Strong analytical and critical thinking skills Proficient in data analysis tools and software Detail-oriented with a knack for identifying trends and anomalies Strong leadership skills with experience in managing and mentoring a high-performing team Excellent communication skills and the ability to work effectively in a fast-paced environment Experience in a small company or start-up environment is preferred What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $170,000 to $187,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Associate Director, Supply Chain

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Key Responsibilities: Lead the biometrics team including statistician, data manager, and statistical programmer at a program level. Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies. Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies. Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings. Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data. Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines. CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines. Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities. Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses. Build and develop efficient biostatistical processes and standards. Other duties as assigned. Ideal Candidate: PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry. Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology and causal inference is preferred. Experience with regulatory submissions and interactions with regulatory agencies. Proficiency in statistical software (e.g., SAS, R) and data management systems. Experience with CDSIC including SDTM, ADaM, CDASH. Successful track record of working independently in a matrixed organization and providing solutions to emerging problems. Excellent communication and interpersonal skills, along with organizational skills. Ability to work collaboratively in a multidisciplinary team environment. Experience in people management is preferred. &nbsp; What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Director, Biostatistics

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: We are seeking a strategic, analytical, and detail-oriented leader to serve as the Senior Director of Data Management. This individual will provide functional leadership across clinical programs and serve as the accountable data management lead for some programs. The Senior Director will oversee clinical data management strategy, CRO partnerships, system implementation, and end-to-end data lifecycle management to ensure high-quality and submission-ready clinical data. This role requires both strategic oversight and the hands-on ability to guide operational execution across study start-up, conduct, database lock, and archival, while ensuring regulatory compliance and inspection readiness. Key Responsibilities: Provide strategic leadership and oversight of data management activities across clinical studies and programs. Serve as the functional lead for clinical data management, ensuring alignment with data management processes, development timelines and corporate objectives. Oversee the design, review, and approval of case report forms (CRFs) and related data collection tools. Guide clinical database and systems (e.g., EDC, IRT, eCOA, external data integrations) development, validation, UAT, and lifecycle management. Ensure execution of data management activities across study start-up, study conduct, database lock, and documentation archival. Oversee Data Management CROs and vendors, ensuring deliverables meet quality standards and timelines. Oversee and drive development and approval of key study-level data management deliverables (e.g., Data Transfer Agreements, Data Management Plans, edit check specifications, eCRFs). Lead cross-functional data review activities and proactively identify data trends, risks, and mitigation strategies. Ensure compliance with GCP, ICH guidelines, CDISC standards, and applicable regulatory requirements. Support regulatory submissions and inspection readiness activities. Mentor and develop internal data management staff as the function scales. Other duties as assigned.&nbsp; Ideal Candidate: Bachelor’s degree is required with 12-15+ years of data management experience in the pharmaceutical, biotech, or CRO industry.&nbsp; Demonstrated leadership experience overseeing studies and/or managing CRO/vendor partnerships. Experience building or scaling data management processes in a growing organization is preferred. Extensive hand-on knowledge and experience in data management activities, CRF and EDC design, review, and validation, and external data transfer and reconciliation. Working knowledge of CDISC standards (SDTM) and experience supporting data transformation for regulatory submissions. Deep understanding of GCP, ICH, and global regulatory requirements. Excellent interpersonal communication skills, along with organizational skills. Proven ability to operate independently and lead effectively within a matrixed organization. Strong strategic thinking and problem-solving capabilities. Experienced people manager with effective delegation skills. Excellent communication, leadership, and organizational skills.&nbsp; What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $265,000 to $282,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Director, Data Management

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Associate Director, Drug Product is a key leadership role responsible for overseeing technical operations related to drug product (DP) formulation, development, and manufacturing. This position requires close collaboration with cross-functional teams, including CMC, supply chain, clinical operations, regulatory, quality, and senior management. This role will lead the development of protein drug product processes and associated technical presentations, oversee technology transfer to CDMOs, and ensure the reliable delivery of high-quality DP supplies to support clinical trials. The ideal candidate brings deep expertise in process development, aseptic manufacturing (including prefilled syringes), combination product development, and GMP compliance. As a subject matter expert (SME) in DP manufacturing within the CMC organization, this individual will provide strategic direction and technical leadership across internal teams and external partners, driving alignment and execution from development through clinical supply. Key Responsibilities: Serve as a SME in DP process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams Develop late-phase and commercial launch strategy for PFS and vial drug products Oversee DP tech transfer, process development, and GMP manufacturing operations including person in plant (PiP) support Manage DP CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members Support phase-appropriate strategies for DP development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness Perform risk assessments using a QbD approach to define DP process validation strategies Collaborate with manufacturing development and device teams to develop DP presentations in vial, PFS, autoinjector, and advanced drug delivery technologies 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.) Other duties as assigned Ideal Candidate: Bachelor’s degree or advanced degree in chemical engineering, biochemical engineering, chemistry, biotechnology or related field, or commensurate years of education and experience Minimum 8[JS2.1] years of relevant experience in biotech/pharma industry 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 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% of domestic travel. In person attendance at Spyre All Hands meetings is required, typically held twice per year. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $ 180,000 to $193,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Associate Director, Drug Product

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The &nbsp;Senior CMC Operations Specialist supports execution across Technical Operations by coordinating cross-functional activities spanning DS/DP, AD/QC, Supply Chain, Device, Regulatory CMC, and Quality to enable on-time manufacturing and release. This role manages task intake, documentation workflows, and action item tracking, while ensuring GMP documentation is complete, accurate, and inspection-ready. It also coordinates vendor interactions, sample shipments, and inventory tracking to maintain operational continuity. Acting as a liaison between functions, this position helps ensure alignment, compliance, and efficient day-to-day execution in a fast-paced environment. The position reports to the Director, CMC Operations. Key Responsibilities: Serve as central coordinator across TechOps functions, supporting execution of cross-functional projects and activities Manage vendor and internal task intake, including tracking, documentation routing, and approval coordination Coordinate sample shipments and maintain inventory tracking to ensure accuracy and availability Provide logistics support for Supply Chain, including shipments of clinical drug product and finished goods Ensure completeness, accuracy, and organization of GMP documentation, including remediation and structuring of legacy files Maintain and track action items across projects, ensuring timely follow-up and closure Act as liaison between TechOps and Quality, supporting alignment with quality systems and processes Other duties as assigned Ideal Candidate: Bachelor’s degree in life sciences, engineering, or related field&nbsp; Minimum 3 years in biotech/pharma operations or analytical/CMC functions. Experience working in GMP or other regulated environments. Demonstrates high accountability and personal responsibility. Strong project management and cross-functional coordination experience. Skilled in documentation management and vendor communication. Proficiency in Microsoft Office and SharePoint tools. Experience creating and maintaining dashboard tools Demonstrated initiative, organization, and attention to detail. Excellent written communication and follow-through in a remote, fast-paced setting. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $135,000 to $155,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior CMC Operations Specialist, Technical Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: Director, Analytical Sciences is responsible for overseeing biologics analytical development and testing activities across Spyre’s clinical and late stage mAb programs. It is a key leadership role in the analytical organization and directly reports to the Vice President of the analytical group. This role provides strategic and operational leadership for analytical method development, validation, transfer, and GMP quality control testing, in close collaboration with global CDMO partners. The Director establishes strong cross‑functional partnerships with development groups within Technical Operations as well as with Quality Assurance to design and implement robust analytical control strategies that align with regulatory requirements and industry best practices. The role also drives proactive planning to support efficient progression of drug candidates across clinical stages.&nbsp; Key Responsibilities: Provide strategic and technical leadership for analytical development and quality control activities across the biologics portfolio, including method development, validation, transfer, and lifecycle management, with primary execution through global CDMO partners. Serve as a subject‑matter expert for biologics analytical assays and control strategies, contributing to regulatory submissions, driving scientific rigor, assay performance monitoring, and continuous improvement initiatives. Analytical control strategy includes QC methods (SEC, CE, CEX, iCIEF, PMAP, HIC, RP, compendial methods etc) and characterization methods (Fc function assays, mass spectrometry, biophysical-structural, particle characterization, surfactant analysis etc). Lead analytical method transfer, qualification, and validation activities at CDMO laboratories, including review and approval of protocols, reports, data packages, and verification of analytical results. Ensure analytical activities performed internally and at CDMOs are scientifically rigorous, comply with FDA, cGMP, ICH, and QbD principles, and align with industry best practices and company quality standards and procedures. Partner closely with Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external (CDMO) analytical documents and data. Other duties as assigned.&nbsp; Ideal Candidate: Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related discipline, with 10+ years of biopharma industry experience in analytical development and quality control for protein biologics. Demonstrated success supporting regulatory submissions (IND, CTA, BLA), with deep expertise in phase‑appropriate method development and validation, analytical control strategies, and cGMP requirements. Proven leader with strong communication skills, capable of managing biologics program deliverables in a fast‑paced environment; experience in mAb-mAb combination product analysis is a plus. &nbsp;Excellent communication skills and the ability to work effectively in a fast-paced environment. Experience in a small company or start-up environment is a plus. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $195,000 to $225,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Analytical Sciences

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Director, Drug Safety Physician will play a pivotal role on our Drug Safety &amp; Pharmacovigilance team helping to advance the development of our cutting-edge antibody portfolio. This position’s deliverables include: Individual Case Safety Report (ICSR) review and aggregate safety monitoring (DSUR, etc.), oversight of cases/AOSE for expedited safety reporting, contributing to safety assessment, safety surveillance, signal detection, risk management planning and strategy, clinical trial document review (protocol, IB, ICF), and ensuring pharmacovigilance compliance with global regulatory requirements. Key Responsibilities: Perform triage and medical review of ICSRs (in or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting Lead cross-functional medical review discussions pertaining to Individual Case Safety Report (ICSR) review. Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings. Participate in safety data review including safety surveillance activities and the evaluation &amp; management of safety signals emerging from any data source. Participate and co-present cases at safety management team meetings and co-lead safety surveillance and signal management meetings.&nbsp; Participate in process improvement projects related to medical review and assessment, safety surveillance, and relevant aspects of PV compliance Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, surveillance plans. &nbsp; Works closely and assists the Medical Review Lead on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations (relevant to medical review of ICSRs and/or safety surveillance aspects), and provides ongoing input on study protocols, periodic reports (DSUR), safety management plans etc. &nbsp; Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings. Ensure that tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements. Provide medical safety strategy and execution of benefit-risk management strategies for assigned products. Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries. Provide input into the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development. Provide input to other safety activities as requested. Other duties as assigned.&nbsp; Ideal Candidate: MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry Working experience / proficiency in Argus global safety database and medical review activities Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above &nbsp; Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $280,000 to $315,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Drug Safety Physician

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities. You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents. Key Responsibilities: Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs. Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports. Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone. Device &amp; Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions. Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression. Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions. Other duties as assigned. Ideal Candidate: Bachelor’s degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience). Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation. Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development. Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations. Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus. Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses. Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment. Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams. Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories). What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $175,000 to $195,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Associate Director, Regulatory Affairs CMC and Devices

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: Spyre Therapeutics is seeking a highly strategic and hands-on commercial leader to shape the future commercial success of our lead assets across IBD and rheumatology as we advance from Phase 2 into Phase 3 and ultimately launch. This individual will serve as a key commercial leader in the company, integrating market access, commercial strategy, and early marketing insights to ensure the portfolio is positioned for optimal value, adoption, and access at launch. This role requires a builder and strategic mindset, comfort with ambiguity, and the ability to influence cross-functional decisions that will define the product’s long-term commercial trajectory. Key Responsibilities: Market Access &amp; Value Strategy Develop the global pricing strategy, including scenario planning, pricing corridors and gross-to-net assumptions Map evidence requirements and gaps to support global payer and HTA decision-making Build early payer engagement strategy and plan Assess patient support landscape and build launch strategy, inclusive of hub, call center, copay, nurse, and field reimbursement Develop US channel strategy for Spyre launch brands Determine optimal global launch waves and sequencing to optimize commercial value Regularly monitor global policy and pricing landscape changes and assess impact to Spyre portfolio Partner with competitive intelligence team to monitor competitor pricing and access dynamics and impact to Spyre Commercial &amp; Asset Strategy Partner with CCO and corporate strategy team to refine commercial strategy as Spyre clinical profiles solidify and the competitor landscape shifts Influence Phase 3 clinical trial design to ensure alignment with key commercial considerations including pricing, access and demand Partner with R&amp;D, Regulatory and Corporate Strategy to refresh target product profile (TPPs) Identify and mitigate key commercial risks ahead of Phase 3 investment decisions Conduct market research to assess drivers of physician adoption and patient access Launch Planning Partner with CCO to build an integrated launch plan, including a detailed commercial launch plan inclusive of commercial resourcing and organizational design Identify and partner with external partners who can support commercial launch preparation Forecasting &amp; Analytics Lead commercial forecasting and scenario modeling, incorporating market access dynamics, competitive landscape, and adoption assumptions Partner with Finance team to conduct ROI assessments to aid with portfolio prioritization and launch sequencing strategy External Engagement Generate insights through engagement with payers, KOLs, and advisors Partner with Medical team to execute cross-functional KOL engagement plan Cross-Functional Leadership Serve as the commercial lead on Spyre Product Teams Ensure alignment between development strategy and commercial success factors Contribute to Board and investor materials Engage with potential strategics and represent commercial voice in discussions Team Leadership Identify and recruit top talent to join commercial organization as the team grows Lead, develop and mentor future direct reports Other duties as assigned Ideal Candidate: 12+ years of experience in biotech/pharma across market access, commercial strategy, and/or marketing Demonstrated experience developing biotech/pharma commercial and access strategy for assets in Phase 2 and Phase 3 development Commercial launch and/or in-line experience, in market access and/or marketing Expertise partnering with R&amp;D, Medical and Regulatory to develop value maximizing Phase 3 designs and TPPs Deep understanding of global payer dynamics, pricing strategy, and patient access/services Experience in commercial forecasting and strategic planning Experience building commercial and cross-functionally integrated launch plans Track record of successfully influencing across functions Excellent communication skills with the proven ability to work effectively in a fast-paced environment What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $330,000 to $357,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Vice President, Commercial Strategy & Market Access

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As the Senior Manager, Regulatory Affairs CMC), you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones. This is a high-impact, high-ownership role for someone who thrives in a fast-moving biotech environment.You will be expected to lead from the front—writing, project-managing, problem-solving, and delivering—not just coordinating. This role requires technical CMC expertise, strong communication skills, and the ability to manage multiple priorities. Key Responsibilities: Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines. Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.). Own CMC regulatory deliverables end-to-end with minimal oversight. Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness. Identify risks early and lead teams to resolution to keep programs on track. Translate complex technical data into clear and concise narratives. Lead preparation of CMC-related responses to HA questions. Act as a connector and leader in discussions, not a passive participant. Manage multiple programs, while prioritizing effectively. Other duties as assigned. Ideal Candidate: Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience). Experience as the primary CMC regulatory lead for clinical stage programs (EU CTR and ROW experience is a plus). Hands-on authoring experience for IND and IMPD submissions and amendments, including direct responsibility for authoring CMC sections. Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses. Proven experience preparing responses to CMC health authority questions during clinical development. Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, and ICH. Strong attention to detail, organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment. Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams. Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories). What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $150,000 to $176,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Manager, Regulatory Affairs CMC

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Associate Director, Analytical Sciences and Attribute Characterization, oversees structural and functional characterization and comparability studies across Spyre’s clinical and late-stage mAb and mAb-mAb combination programs. This role is a key leader within the Analytical Development and Quality Control (ADQC) organization and reports directly to the Vice President. The position provides both strategic and operational leadership for analytical characterization and comparability, in close collaboration with internal process, analytical, and regulatory teams, as well as global CDMO partners. The Associate Director defines phase-appropriate characterization and comparability strategies that support formulation, process, and analytical development, quality control, and regulatory submissions, aligned with regulatory expectations and industry best practices. This role drives proactive planning to ensure efficient advancement of drug candidates through clinical development stages. Key Responsibilities: Provide strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner, enabling regulatory submissions for clinical development through BLA &amp; MAA, primarily executed through global CDMO partners. Serve as subject matter expert (SME) in mAb and mAb-mAb combination product molecular characterization and comparability, applying a fit-for-purpose suite of biochemical, biophysical, physicochemical, and functional assays (e.g., advanced mass spectrometry, capillary and chromatographic methods, deterministic biophysical and particle analyses, Fc function assays including SPR, cell-based assays, and surfactant analysis). Contribute to analytical control strategies and regulatory content development, ensuring scientific rigor, comprehensive product understanding, and assessment of process impacts on product quality attributes across DS, DP, placebo, and device manufacturing. Lead comparability and characterization activities at CDMOs, including review and approval of protocols, reports, and data packages, and verification of analytical results to support regulatory submissions. Ensure analytical activities, both internal and external, meet scientific, regulatory (FDA, EMA, ICH), and industry standards. Develop characterization strategies in collaboration with analytical SMEs, ensuring alignment and complementarity with QC methods for release, stability, and in-process controls. Partner with process (DS, DP, device) and regulatory teams to establish product-appropriate characterization and comparability plans. Support ADQC activities, including method development, investigations, and review of QC release and stability data, as needed. Establish best practices and protocols for structure–function relationships, post-translational modification (PTM) analysis, biophysical characterization, and critical quality attribute (CQA) assessment. Other duties as assigned.&nbsp; Ideal Candidate: Advanced degree in Mass spectrometry, Biophysical chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related discipline, with 8+ years of biopharma industry experience in biologics analytical, formulation or process development. Demonstrated experience and success supporting regulatory submissions (IND, CTA, BLA), with strong expertise in phase-appropriate characterization and comparability studies and associated analytical methods. Proven leadership and effective communication skills, with the ability to manage biologics program deliverables in a fast-paced environment; experience with mAb combination products is preferred, and device testing is an advantage. Experience leveraging artificial intelligence (AI) and machine learning (ML) to enhance analytical efficiency, automate attribute trending, and support knowledge generation and decision-making. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $175,000 to $190,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Associate Director, Analytical Sciences and Attribute Characterization

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Clinical Trial Manager (CTM) is a pivotal role responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. The CTM will organize and supervise clinical trials, ensuring they meet all company and regulatory requirements. The CTM will collaborate closely with internal R&amp;D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success. Key Responsibilities: Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion.&nbsp; Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements. Create and implement study-specific clinical monitoring tools and documents,&nbsp;including informed consent development and EU CTR. Lead the identification, evaluation, selection, and oversight of clinical trial sites. Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites. Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations. Responsible for implementation and oversight of Trial Master File for inspection readiness. Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates. Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents. Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members. Provide study updates and reports, inclusive of study risks and issues. Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings. Responsible for ongoing study data reviews and data cleaning activities. Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, sample tracking, interim monitoring and close out activities. Manage trial-level quality risk management. Oversee study supplies management. Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes. Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections. Other duties as assigned. Ideal Candidate: B.A./B.S. in life sciences or equivalent&nbsp; A minimum of 5 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials; managing global clinical trials a plus Inflammation and/or Immunology experience is strongly preferred&nbsp; Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out Informed consent development and EU CTR experience Ability to lead cross functional study teams in a matrix organization Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $135,000 to $155,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp; &nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Clinical Trial Manager, Clinical Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: Spyre Therapeutics, Inc., is actively recruiting an experienced Senior Payroll and Accounting Specialist to join our accounting team. The Payroll and Accounting Specialist will be a key member of the accounting department, responsible for the integrity of the Company’s compensation cycles and equity administration. Responsibilities include full-cycle general ledger accounting, end-to-end payroll administration, equity platform management, and ensuring strict adherence to Sarbanes-Oxley (SOX) requirements. This position will support our increased operational needs as our company grows, playing a vital role in reconciling stock-based compensation, managing payroll tax compliance, and other accounting tasks as needed. Attention to detail and the ability to maintain precise account balances and general ledger accuracy are all essential skills for this position. The ideal candidate should be comfortable working collaboratively with cross-functional teams and independently and excel when faced with the unique challenges of a scaling organization. Key Responsibilities: Manage the full-cycle payroll process, including data entry, tax withholdings, and benefits deductions, etc. Ensure all payroll activities align with federal, state, and local tax regulations, including the proper handling of withholdings and filings. Perform regular audits of payroll data and reconcile payroll bank accounts to ensure accuracy and identify discrepancies. Coordinate with HR to ensure accurate deductions for health insurance, retirement plans (401k), and other voluntary benefits. Act as the primary point of contact for staff regarding pay-related inquiries, resolving issues related to paychecks or tax forms with high confidentiality. Identify opportunities to streamline payroll workflows and improve the efficiency of the payroll software or HRIS. Prepare and post monthly journal entries for payroll accruals, benefits, taxes, and other standard corporate expenses. Maintain T&amp;E system including syncing to the Company’s ERP and reviewing expense transactions for compliance with Company policies. Assist in the preparation of monthly and quarterly financial statements by ensuring all payroll-related expenses are accurately categorized. Maintain and document internal controls (such as SOX compliance procedures) to ensure the integrity of financial reporting and prevent fraud. Facilitate the issuance of new equity awards (RSUs, Stock Options, or ESPP) by ensuring all grant agreements are properly executed and recorded in the equity platform. Monitor vesting schedules and process stock option exercises, ensuring the accurate flow of data between the equity platform and payroll for tax withholding. Other duties as assigned. Ideal Candidate: Bachelor’s degree in Accounting or related field 5+ years of payroll and accounting experience Experience managing payroll and tax withholdings across multiple states. Experience with international locations is a plus. Proficiency in payroll/HRIS and equity management platforms (i.e. Rippling, Fidelity, E*TRADE) Solid understanding of the lifecycle of various equity vehicles, including RSUs, NSOs, ISOs, and ESPPs. A proven track record of handling highly sensitive executive compensation and employee financial data with total discretion. Excellent organizational, analytical, prioritization and problem-solving skills in an environment of high volume of projects; detail-oriented Possesses a professional demeanor, discretion and judgment Ability to work effectively and establish and promote positive relationships Self-starter who possesses initiative and ability to work alone while capable of driving business results without significant supervision Must have schedule flexibility to meet the demands of monthly and quarterly close Excellent verbal and written communication skills Ability to work effectively with all employee levels and external contacts What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $110,000 to $130,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Payroll and Accounting Specialist

<div class="content-intro"><p>Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.</p></div><p>Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.</p>
<p><strong>Role Summary</strong></p>
<p>Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The Senior Manager, GCP Quality will support Clinical Quality Assurance (CQA) activities across Spyre’s clinical development programs, including the planning and execution of audits, management of quality issues and investigations, inspection readiness activities, and ongoing compliance oversight. This role requires strong knowledge of GCP regulations and quality systems, as well as the ability to collaborate effectively across functions to promote a culture of quality and continuous improvement.</p>
<p>&nbsp;</p>
<p>The Senior Manager will partner closely with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to ensure compliance with Spyre policies, procedures, and applicable global regulations and guidelines, including FDA, EMA, ICH, and other relevant regulatory requirements.</p>
<p><strong>Key Responsibilities</strong></p>
<ul>
<li>Provide guidance and support on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) requirements to clinical development teams, helping identify compliance risks and support implementation of appropriate mitigations.</li>
<li>Collaborate with internal stakeholders and external partners, including CROs, vendors, contract auditors, and investigator sites, to support quality oversight activities and promote consistent compliance across development programs.</li>
<li>Assist in the development and execution of risk-based audit plans for assigned programs and support inspection readiness initiatives.</li>
<li>Independently plan, conduct, manage, and report domestic and international audits of investigator sites, vendors, systems, and processes in accordance with applicable regulations and Spyre procedures.</li>
<li>Evaluate audit observations and quality issues for potential impact on participant safety, data integrity, and regulatory compliance.</li>
<li>Support investigations related to quality events, protocol deviations, compliance concerns, and potential GCP/GLP/GVP issues; assist with root cause analysis, CAPA development, implementation, and effectiveness verification.</li>
<li>Contribute to health authority inspection readiness activities and provide quality support during regulatory inspections and vendor audits.</li>
<li>Track, analyze, and communicate quality metrics and trends to support continuous improvement and risk management activities.</li>
<li>Partner with the broader Quality organization to identify opportunities for process improvements and harmonization across programs and functional areas.</li>
<li>Support the maintenance and continuous improvement of Spyre’s Quality Management System (QMS), including procedures, training, CAPA, and audit management processes.</li>
<li>Maintain awareness of evolving regulatory requirements and industry best practices and help ensure appropriate implementation within the organization</li>
<li>Other duties as assigned</li>
</ul>
<p><strong>Ideal Candidate</strong></p>
<ul>
<li>BA/BS degree, preferably in biological sciences, or related field</li>
<li>Minimum of 6+ years of experience in the pharmaceutical, biotechnology or related health care industry</li>
<li>Minimum 4+ years of GCP-related Quality Assurance or relevant clinical trial and medical device experience</li>
<li>Strong knowledge of ICH-GCP, GLP, GVP, FDA regulations, EMA requirements, and other applicable global clinical development regulations and guidelines.</li>
<li>Experience conducting and/or managing GCP audits of investigator sites, vendors, CROs, and clinical systems.</li>
<li>Experience supporting regulatory inspections and inspection readiness activities preferred.</li>
<li>Working knowledge of Quality Management Systems, including CAPA, deviation management, risk assessment, change control, document management, and training systems.</li>
<li>Demonstrated ability to analyze regulations and apply quality and compliance principles in a practical, risk-based manner.</li>
<li>Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.</li>
<li>Excellent written and verbal communication skills and the ability to effectively collaborate across functions and organizational levels.</li>
<li>Detail-oriented with strong problem-solving and critical-thinking capabilities.</li>
<li>Ability to work independently while also contributing effectively as a member of a collaborative team.</li>
<li>Travel may be required up to 15% of the time</li>
</ul>
<p><strong>What We Offer</strong></p>
<ul>
<li>Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>The expected salary range offer for this role is $149,000 to $175,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;</p>
<p>&nbsp;</p><div class="content-conclusion"><p>As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.</p>
<p>Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div>

Senior Manager, GCP Quality Assurance

<div class="content-intro"><p>Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.</p></div><p><strong>About Spyre Therapeutics</strong></p>
<p>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.&nbsp;</p>
<p>&nbsp;</p>
<h1>Role Summary</h1>
<p>The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.</p>
<p>&nbsp;</p>
<h1>Key Responsibilities</h1>
<ul>
<li>Lead the biometrics team including statistician, data manager, and statistical programmer at a program level</li>
<li>Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies</li>
<li>Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies</li>
<li>Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings</li>
<li>Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data</li>
<li>Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines</li>
<li>CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines</li>
<li>Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities</li>
<li>Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses</li>
<li>Build and develop efficient biostatistical processes and standards, when appropriate</li>
</ul>
<h1>Ideal Candidate</h1>
<ul>
<li>PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.</li>
<li>Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology is preferred.</li>
<li>Experience with regulatory submissions and interactions with regulatory agencies.</li>
<li>Proficiency in statistical software (e.g., SAS, R) and data management systems.</li>
<li>Experience with CDSIC including SDTM, ADaM, CDASH</li>
<li>Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.</li>
<li>Excellent communication and interpersonal skills, along with organizational skills.</li>
<li>Ability to work collaboratively in a multidisciplinary team environment.</li>
</ul>
<h1>What We Offer</h1>
<ul>
<li>Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>&nbsp;</p>
<p>The expected salary range offer for this role is $ 275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;</p>
<p>&nbsp;</p><div class="content-conclusion"><p>As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.</p>
<p>Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div>

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