Associate Director, Clinical Supplies (Remote, CST/EST)

Position Summary

The Associate Director, Clinical Supplies is responsible for leading the operational management of investigational product (IP) supply activities in accordance with GxP requirements. This role partners closely with Clinical Operations, Technical Operations, Quality Assurance, Regulatory Affairs, Clinical Pharmacology, and external vendors to ensure timely packaging, labeling, distribution, accountability, and forecasting of investigational product across global clinical trials. The Associate Director contributes to clinical supply strategy, manages outsourced vendors, and supports study teams throughout protocol development and supply planning.

Responsibilities

• Lead CMOs, depots, and clinical supply vendors responsible for packaging, labeling, distribution, and inventory management of investigational products across all phases of clinical development.
• Partner with cross-functional teams to develop accurate clinical supply forecasts, budgets, and study timelines.
• Contribute to protocol development with emphasis on investigational product preparation, administration, and supply feasibility.
• Author and maintain Pharmacy Manuals and Investigational Product Handling Manuals.
• Ensure training of clinical sites and vendors on investigational product handling, storage, accountability, and return/destruction procedures.
• Lead implementation, User Acceptance Testing (UAT), maintenance, and troubleshooting of IRT systems with external partners.
• Provide expertise in global clinical supply chains, including temperature-controlled products and international logistics.
• Support compliance with global import/export regulations governing investigational products.
• Monitor vendor performance through governance meetings and KPI reviews.
• Manage purchase orders, vendor invoices, and study supply budgets.
• Identify supply chain risks and implement mitigation strategies.
• Mentor junior staff and contribute to SOP development and continuous process improvement.
• Additional duties assigned as needed.

Education and Experience

• Bachelor's degree, or equivalent, in a biomedical, life science, supply chain, or related field required. Equivalent combinations of education and experience may be considered.
• 8+ years of clinical supply chain experience within biotechnology, pharmaceutical, or CRO settings required.
• Experience supporting global Phase I-IV clinical trials.
• Experience managing external vendors, including CMOs, depots, and IRT providers.

Target comp based on level/experience 150-195K