Spyre Therapeutics

• 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.

• 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.

• 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.

• 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.

• 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

• 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.

• 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.

• 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 & 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. • 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. • 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. • 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.

• 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

• 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