Spyre Therapeutics

Director

• 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.

Director, Drug Safety Physician

• 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.

Director, Analytical Sciences

Operations

• 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

Senior CMC Operations Specialist – Technical Operations

• 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

Associate Director, Drug Product

• 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.

Senior Director, Data Management

• Provide leadership and strategic input for clinical development programs assigned.
• 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.
• 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.
• 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.
• Establish procedures through regular interaction, setting expectations on deliverables and timelines for CRO / Vendor Oversight. Ensure deliverables are accurate and delivered according to timelines.
• 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.

Senior Director, Biostatistics

Supply Chain

• 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
• Other duties as assigned

Associate Director, Supply Chain

Administrative Assistant

• Provide administrative support for team members across the organization
• Schedule meetings to include both internal and external parties
• 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
• Assist with meeting planning such as sourcing hotels, meeting space, conference registration and tracking tasks
• Assist with special projects such as all company events and offsites, onboarding/offboarding contractors and employees and contributing to our Admin SharePoint site
• Build strong cross-functional relationships and partner with other administrators to ensure a high functioning & collaborative admin team environment