Employer profile
Spyre Therapeutics Inc
5 open roles indexed with location, benefit, and apply-link signals where available.
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Showing the most recent indexed roles for this employer.
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Senior Payroll and Accounting Specialist
US- Remote
remote $110K-$130KSenior Payroll and Accounting Specialist US- Remote 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. 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
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Clinical Trial Manager, Clinical Operations
US- Remote
remote $135K-$155KClinical Trial Manager, Clinical Operations US- Remote 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. 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&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. - 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, 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
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Associate Director, Analytical Sciences and Attribute Characterization
US- Remote
remote $175K-$190KAssociate Director, Analytical Sciences and Attribute Characterization US- Remote 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. 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 & 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
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Senior Manager, Regulatory Affairs CMC
US- Remote
remote $150K-$176KSenior Manager, Regulatory Affairs CMC US- Remote 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. 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
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Senior Director, Biostatistics
US- Remote
remote $275K-$290KSenior Director, Biostatistics US- Remote 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. 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