Clinical Supply Chain in cross-functional Clinical Study Team, CRO and vendor meetings.•Authors pharmacy manuals and participates in reviews of other study related documentation•Serve as the primary point of accountability for shipping and logistics requests across Technical Operations, Development Sciences, Biology and Chemistry teams, including transfers of GMP and non-GMP materials (intermediates, drug substance, drug product, testing samples etc.)•Manage relationships with couriers, freight forwarders, and specialty cold-chain carriers•Own import/export compliance, including licenses, permits, customs documentation, and country-specific import requirements for material shipments.•Oversee cold-chain and temperature-controlled shipment execution, including packaging qualification, temperature excursion investigation, and corrective action.•Monitor shipment status end-to-end, coordinate with vendors on inbound/outbound logistics, proactively resolve delays or exceptions, and maintain shipment tracking and reporting for cross-functional stakeholders.•Ensure all clinical supply and logistics activities comply with GMP, GCP, and applicable import/export regulations.•Maintain inspection-ready documentation and ensure clinical supply and shipping records are filed appropriately in the eTMF/quality systems.•Support the creation and revision of SOPs related to clinical supply chain and logistics processes.•Lead or contribute to deviation, CAPA, and investigation processes related to supply or shipping issues (e.g., temperature excursions, shipment delays or damage). Director: typically 10+ years, of clinical supply chain experience in biotech/pharma, with direct experience in packaging, labeling, and distribution of investigational products through all stages of international clinical studies (start-up, enrollment, maintenance and close-out)•Demonstrated experience managing shipping, logistics, or distribution operations, including carrier/freight-forwarder management and import/export or customs compliance.•Experience with IRT/RTSM systems, clinical supply forecasting tools, and CMO/depot network management.•Experience in rare disease, cardiology, or genetic medicine clinical trials is a plus.•Working knowledge of GMP, GCP, and global import/export regulations relevant to clinical trial materials.•Strong vendor management, negotiation, and cross-functional collaboration skills.•Ability to manage multiple competing priorities in a fast-paced, growing biotech environment.•Excellent analytical, organizational, and written/verbal communication skills.•Comfort operating with the autonomy and hands-on scope typical of a small, growing company.•Some domestic and/or international travel may be required to support vendor, depot, or CMO site visits.•This role is based in San Diego, CA or Remote.