Teams at Spyre Therapeutics

Lead biostatistics for clinical development programs: design trials, author SAPs/protocol statistical sections, manage biometrics team and vendors, perform/adjudicate analyses, support regulatory interactions, and build standards/processes.

Supports global regulatory strategy and execution for Phase 3 clinical programs, including study start-up, clinical trial applications, INDs, CTAs, amendments, annual reports, DSURs, and health authority responses. Coordinates regulatory documents, submission plans, CRO and vendor oversight, risk mitigation, regulatory intelligence, compliance, and inspection readiness. Collaborates cross-functionally with Clinical Development, Operations, Safety, CMC, Quality, and other teams while managing multiple global submissions.

Lead GCP Quality Assurance activities across clinical programs including audit planning and execution, managing quality issues and investigations, inspection readiness, vendor/CRO oversight, CAPA and QMS maintenance, quality metrics and continuous improvement, and cross-functional compliance support with global regulations (FDA, EMA, ICH).