Spyre Therapeutics

Vice President

• Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.
• Develop and continuously refine integrated clinical development plans aligned with corporate objectives, competitive landscape, and evolving scientific insights.
• Serve as a hands-on study lead for the current platform trial as well as contribute to planning pivotal studies.
• Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and future IBD clinical trials.
• Support the efforts of the medical monitoring team which ensures timely responses to investigative sites, provides medical safety oversight, and supports the collection of high-quality, clinically robust data.
• Provide medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across all phases of development.
• Lead protocol development, study conduct, data review, and interpretation for ongoing clinical trials, partnering closely with clinical operations, regulatory, biometrics, etc., to ensure successful execution.
• Drive key development decisions through analysis of emerging clinical, translational, safety, and competitive data.
• Chair or contribute to governance committees and cross-functional program teams.
• Partner closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, Commercial, and Corporate Development teams to ensure coordinated execution of development strategies.
• Promote a culture of scientific excellence, accountability, and collaboration.
• Lead clinical and medical strategy for regulatory interactions globally.
• Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and related responses.
• Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices.
• Provide ongoing medical oversight of participant safety and benefit-risk assessments across assigned programs.
• Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums.
• Support signal detection, risk management planning, and clinical risk mitigation strategies.
• Lead and mentor a high-performing clinical development team as the company grows.
• Contribute broadly to corporate strategy, organizational planning, and leadership initiatives.

Vice President, Clinical Development

Medical Director

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Senior Medical Director, Clinical Development

Clinical Research

• Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders.
• Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation.
• Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs.
• Work closely with translational science/biomarker teams to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints.
• Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out.
• Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally (e.g., to senior management or clinical development committee) and externally (investigators, scientific meetings, publications).
• Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders.
• Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes.
• Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions.
• Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.).
• Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre’s pipeline programs.
• Additional duties as assigned.

Clinical Scientist, Clinical Development

Payroll

• 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&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.

Senior Payroll and Accounting Specialist

Clinical Operations

• 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 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.

Clinical Trial Manager, Clinical Operations

Director

• Oversee structural and functional characterization and comparability studies across Spyre’s clinical and late-stage mAb and mAb-mAb combination programs.
• Provide strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner.
• Serve as subject matter expert (SME) in mAb and mAb-mAb combination product molecular characterization and comparability.
• Contribute to analytical control strategies and regulatory content development.
• Lead comparability and characterization activities at CDMOs.
• Ensure analytical activities meet scientific, regulatory and industry standards.
• Develop characterization strategies in collaboration with analytical SMEs.
• Support ADQC activities, including method development, investigations, and review of QC release and stability data.
• Establish best practices and protocols for structure–function relationships and critical quality attribute (CQA) assessment.

Vice President, Clinical Development

Senior Medical Director, Clinical Development

Clinical Scientist, Clinical Development

Senior Payroll and Accounting Specialist

Clinical Trial Manager, Clinical Operations

Associate Director, Analytical Sciences, Attribute Characterization