Spyre Therapeutics

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.

Associate Director, Analytical Sciences, Attribute Characterization

Compliance

• 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.

Senior Manager, Regulatory Affairs CMC

Vice President

• 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
• 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&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
• 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
• 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
• Generate insights through engagement with payers, KOLs, and advisors
• Partner with Medical team to execute cross-functional KOL engagement plan
• 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
• Identify and recruit top talent to join commercial organization as the team grows
• Lead, develop and mentor future direct reports
• Other duties as assigned

Vice President, Commercial Strategy, Market Access

• 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 & 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.

Senior Payroll and Accounting Specialist

Clinical Trial Manager, Clinical Operations

Associate Director, Analytical Sciences, Attribute Characterization

Senior Manager, Regulatory Affairs CMC

Vice President, Commercial Strategy, Market Access

Associate Director – Regulatory Affairs CMC, Devices