Associate Director, Clinical Supplies

Role: Associate Director, Clinical Supplies, overseeing global clinical trial materials management, including forecasting, packaging, labeling, distribution, and reconciliation. Responsibilities: managing supply chain operations, vendor oversight (CMOs, shipping agents), ensuring compliance with cGMP, GCP, FDA, and ICH guidelines, and collaborating across internal teams and external vendors. Leading supply planning based on trial protocols, designing packaging strategies, managing label development, and supporting regulatory documentation. Budget management, project coordination, inventory oversight, and process improvement initiatives are key functions. Managing junior staff and acting as a mentor are also included. Requirements: Bachelor's degree with 8+ years (or Master’s with 6+ years) experience in clinical drug supply, GMP/GCP/ICH expertise, hands-on experience with clinical supply chains, IRT systems, and shipping logistics; proficiency in Microsoft Office and project management tools. Preferred: experience supporting international trials, regulatory filings, and team leadership. High-Value: global clinical trial support, biologics or small molecule supply chains, cGMP compliance, 10-20% travel, and senior-level strategic and operational management.