Jobs · Management · Massachusetts

Associate Director, Clinical Supply Chain, Cambridge, MA

Isomorphic Labs · Cambridge, MA · 4 wk ago
ManagementFull-time

About the role

We are seeking a proactive, self-driven, highly organized, and entrepreneurial Clinical Supply Chain colleague to lead end-to-end clinical trial material (CTM) planning, vendor management, packaging, labeling, inventory management, and global distribution operations. Reporting directly to the Head of Early Development, you will serve as the clinical supply authority within a lean Pharmaceutical Sciences & CMC Manufacturing team, acting as a direct partner to Clinical Operations and the larger Clinical Development organization. As part of an AI-first company, you will help us reimagine how we bring new medicines to patients. This role is designed for growth. As our pipeline advances, you will be the foundational architect of our clinical supply operations - scaling systems, processes, and vendor networks to support future clinical studies in different modalities and therapeutics areas. Operating within an agile model, you will execute operations through external clinical packaging and labeling vendors, central/regional depots, specialized temperature-controlled chain couriers, and Interactive Response Technology (IRT/RTSM) providers. Internally, you will bridge between drug manufacturing with Clinical Operations for clinical trial execution.

Responsibilities

  • Dynamic Demand Forecasting: Build and maintain flexible clinical supply models tailored to the unpredictable pace of clinical trials, ensuring uninterrupted patient dosing while minimizing drug waste.
  • Rapid-Response Resupply: Manage flexible investigational product fulfillment and site replenishment strategies to support dynamic protocol milestones, dose adjustments, and study demand fluctuations across participating trial sites.
  • Pharmacy Manuals & Site Support: Collaborate with internal colleagues and Clinical CROs to author and review the Investigational Product (IP) Handling and Pharmacy Manuals, establishing clear site-level guidance for drug storage, handling, accountability, and dose preparation, reconciliation, and destruction.
  • Packaging & Label Design: Direct secondary packaging, blinding/kitting strategies, and label generation for clinical trial supplies, ensuring regulatory compliance with applicable regional and global standards and regulations.
  • Depot & Logistics Management: Select and manage central and regional clinical depots; oversee qualified

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