Associate Director, Clinical Supply Management
Core
Lead US Medical Affairs Clinical Supply Management (CSM) team to develop drug supply strategy and tactical approach for Sponsored, Investigator Initiated, Managed Access, and Research Collaboration trials.
Role type
Senior IC clinical supply management director
Builds
End-to-end clinical trial drug supply plans, packaging/distribution models, and vendor partnerships
Domain
Biopharma / Clinical Trials / Supply Chain
Required skills
cGMP, 21 CFR Part 11, Annex 13, drug development process, cross-functional collaboration, risk management, cost assessment, IRT/Simulation Tools, GxP audits, vendor management, SOP development
Preferred skills
Interactive Response Technology (IRT) and Simulation Tools set-up and management
Technologies
Interactive Response Technology (IRT), Simulation Tools
Responsibilities
Oversee end-to-end supply strategy from forecast to clinical sites; manage Investigational Medicinal Product (IMP) supply and bulk inventory; advocate supply/financial forecasts for capacity planning; resolve complex supply chain issues to ensure patient supply; lead cost assessment of labeling, packaging, and distribution; set up IRT & Simulation Tool systems; leverage AI-enabled insights for supply planning; onboard new vendors and support GxP audits; manage relationships with CROs, vendors, and external partners; establish SOPs for process improvement.
Seniority
Senior, hands-on IC with people management
