Description

You will lead end-to-end clinical supply execution for a global late-stage clinical trial, owning strategy from demand forecasting through distribution for programs involving prefilled syringes and autoinjectors. You'll partner with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply, with real patient impact during a pivotal stage of the company's evolution.

Requirements

• Bachelor's degree and 15 years of experience or Master's with 12+ years
• 10+ years in clinical supply chain/clinical supply operations
• Direct experience managing Phase 3 clinical trials including global distribution
• Hands-on experience with prefilled syringes and/or autoinjectors in clinical trial setting
• Demonstrated ownership of forecasting and supply planning

Responsibilities

• Own global clinical supply strategy for late-stage programs including demand forecasting, inventory management, and risk mitigation
• Develop integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments
• Lead clinical supply activities for vials, prefilled syringes, and autoinjectors including device assembly, cold-chain, labeling, and blinding
• Manage external vendors including packaging/labeling vendors, global depots, and logistics providers; oversee vendor selection, SOWs, budgets, and performance
• Oversee global distribution ensuring import/export compliance, QP release, and inspection-ready documentation