Pioneering Medicines: Associate Director / Director, Clinical Operations
Core
End-to-end operational leadership for early-phase (Phase 1/2) clinical trials, from study start-up through close-out and CSR generation.
Role type
Senior IC Clinical Development Operations Director
Builds
Novel life-changing treatments for patients with serious diseases via Flagship's scientific platforms
Domain
Biopharmaceutical R&D / Early-phase clinical development
Deliverable
client delivery
Required skills
End-to-end clinical program ownership, early-phase trial execution (FIH/IND), multi-site global trial management, CRO/vendor selection and performance management, regulatory compliance (ICH-GCP/FDA/EMA), clinical data systems (EDC/CTMS/eTMF), budget and timeline management
Preferred skills
Experience in metabolic diseases, obesity, oncology, or rare diseases; startup/small biotech background
Technologies
EDC, CTMS, RTSM, eTMF
Responsibilities
Lead site start-up, patient enrollment, monitoring, and study close-out; Author and review clinical documents (protocols, CSRs, SAPs); Manage trial budgets and operational timelines; Oversee CRO relationships and vendor KPIs; Ensure TMF quality and audit readiness
Seniority
Director, hands-on IC
