Director of Clinical Supplies

The Director of Clinical Supply Chain Management oversees end-to-end clinical supply operations across global clinical programs and multiple study phases. This role is responsible for establishing and managing clinical supply chains, overseeing IRT and distribution vendors, ensuring timely IMP availability, and collaborating cross-functionally to support trial execution. The Director serves as the primary point of contact for internal teams and external partners, leads process improvements, ensures compliance with GxP requirements, and manages all aspects of packaging, labeling, distribution, returns, reconciliation, and destruction activities.

This is a fully remote position.

• Lead clinical supply setup and management for global studies, ensuring timely IMP availability.
• Oversee label generation/approval, packaging, labeling, release, distribution, cold-chain management, and expiry extensions.
• Manage IRT strategy, configuration, and lifecycle oversight.
• Direct CMO and vendor performance related to drug product packaging, distribution, inventory, and reconciliation.
• Develop and maintain Clinical Supply SOPs; initiate and resolve departmental deviations.
• Develop Pharmacy Manuals and ensure IMP readiness at clinical sites.
• Serve as SME and primary representative in clinical supply audits and regulatory inspections.
• Address temperature excursions, product issues, and site/depot deviations in partnership with QA.
• Provide forecasting, drug utilization analysis, and global supply risk mitigation strategies.
• Oversee depot inventory for study drug and comparators.
• Collaborate cross-functionally with Clinical Operations, CMC, QA, Regulatory, CROs, and CMOs.
• Mentor team members and support continuous improvement of GMP/GDP-aligned processes.

• Bachelor’s degree in a scientific, healthcare, or related field; 10+ years of global clinical supply chain experience in biotechnology.
• Strong knowledge of GMP, GCP, GDP, and import/export regulations.
• Proven experience establishing and managing clinical supply chains and third-party vendor relationships (CROs, CMOs).
• Expertise in IRT systems, including setup, testing, troubleshooting, and risk mitigation.
• Experience supporting regulatory inspections and clinical supply audits as an SME.
• APICS certification is a plus.

Director

Contract

Supply Chain