Teams at Spyre Therapeutics

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.

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 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.