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Director, Clinical Supply Chain

Remote, NY

Posted: 06/03/2025 Employment Type: Contract To Hire Job Category: Supplies/Logistics Job Number: 4487

Job Description

Our client is seeking a highly experienced Director, Clinical Supply Chain for a full-time contractor role. This position is a senior individual contributor role responsible for independently managing global clinical supply chain operations across multiple clinical trials and Expanded Access Programs (EAPs).

You will lead project-level planning, vendor oversight, and execution of investigational product (IP) supply, without direct people management responsibilities.

Key Responsibilities:
  • Lead end-to-end clinical supply planning and execution for global clinical studies and EAPs, ensuring timely delivery and regulatory compliance.
  • Develop study-specific supply strategies and manage clinical drug forecasting, packaging, labeling, distribution, and reconciliation.
  • Oversee relationships and day-to-day coordination with third-party vendors, including CMOs, depots, IRT/IWRS providers, and logistics partners.
  • Monitor and manage IP inventory at global depots and clinical sites; proactively mitigate risks related to overages, shortages, and expiry.
  • Collaborate cross-functionally with Clinical Operations, CMC, Regulatory, QA, and Finance to support study timelines and alignment with clinical development plans.
  • Ensure GxP (GMP/GCP) compliance in all supply chain activities, and contribute to SOP development and inspection readiness.
  • Support Expanded Access Programs by coordinating individual patient supply logistics and ensuring adherence to regional regulations.
  • Participate in clinical protocol review to provide input on dosing strategies and supply impact.
  • Lead continuous improvement initiatives to streamline processes and enhance supply chain operations.
Requirements / Qualifications:
  • Bachelor’s degree in Life Sciences, Supply Chain Management, Engineering, or a related field is required.
  • Higher education preferred (e.g., Master’s degree, PharmD, or equivalent in a relevant discipline).
  • 10+ years of experience in clinical supply chain within the biopharmaceutical industry.
  • Direct experience with Expanded Access Programs (EAPs) or Named Patient Programs is strongly preferred.
  • In-depth knowledge of global clinical trial supply logistics, import/export, and temperature-sensitive product handling.
  • Strong vendor management skills and hands-on experience with IRT/IWRS systems.
  • Excellent organizational, communication, and problem-solving abilities.
  • Experience in rare disease or small patient population studies is a plus.
  • Proven ability to independently manage complex projects in a dynamic, fast-paced environment.
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