Jobs at Spyre Therapeutics

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).

Physician leader responsible for strategic and operational oversight of IBD antibody clinical development. Lead the Phase 2 platform trial, drive protocol development, medical review, safety oversight, data interpretation, and regulatory interactions. Partner cross-functionally to design and execute trials, chair governance committees, mentor clinical teams, and shape registrational strategy and program-level decisions.

Lead design, execution, and interpretation of clinical trials for antibody therapies in immunology. Collaborate cross-functionally and with CROs on protocols, regulatory submissions, biomarker integration, PK/PD, data quality, safety review, and reporting. Present findings internally and externally and support strategic program positioning.

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.