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Director, Clinical Supply Chain
Remote, NY US
Posted: 06/03/2025
2025-06-03
2025-07-16
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:
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.
- 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.