Associate Director, Clinical Supply Chain
Core
Manage investigational medicinal product supplies for global clinical-stage trials, translating study info into demand plans and overseeing production, release, and distribution from FPI through trial completion.
Role type
Senior IC clinical supply chain leader
Builds
End-to-end clinical trial drug supply chains for a biopharmaceutical company
Domain
Biopharmaceuticals / Clinical Trials / Supply Chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical supply chain planning, CMO/depot management, global regulatory compliance (cGMP/GCP), budget management, project planning, risk management, vendor management, documentation control (TMF/CSR), cross-functional collaboration
Preferred skills
Manufacturing, Quality, and/or Regulatory experience
Technologies
MS Excel, PowerPoint, MS Project, Office Timeline, RTSM
Responsibilities
Translate clinical trial assumptions into drug forecasts and supply/distribution plans; Lead clinical supply chain execution and support study teams; Serve as primary liaison to Clinical Operations and Vendor Management; Manage study budget and CMO invoices; Plan secondary packaging/labeling and final drug release; Manage Quality Systems documentation (Deviations, CAPAs, Change Controls); Develop project plans and schedules; Proactively manage E2E supply chain risks; Support IND/IMPD/CTA filings.
Seniority
Senior, hands-on IC