Director, Clinical Supply Chain (Clinical Supply), Late Stage

Clinical Supply Strategy & Execution:

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development:

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including device assembly and packaging considerations.
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management:

• Manage external partners including Packaging and labeling vendors, Global depots and regional distribution hubs, and Couriers and specialty logistics providers.
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.