Associate Director, Supply Chain, Logistics

This is a fully remote position, open to applicants in California.

📋 Description

• Provide strategic oversight for clinical supply strategies and develop actionable clinical supply plans.

• Manage IRT/RTSM vendors, including specification gathering, user acceptance testing, and the IRT lifecycle.

• Ensure precise randomization, resupply, and inventory levels across studies and sites.

• Identify and address clinical supply risks while establishing contingency plans.

• Align clinical supply timelines with study start-up, enrollment, and closeout milestones.

• Oversee packaging, labeling, distribution, and return drug management in collaboration with CMOs.

• Represent the Clinical Supply Chain in cross-functional study team meetings, CRO consultations, and vendor discussions.

• Author pharmacy manuals and engage in the review of study documents.

• Manage shipping and logistics requests for GMP and non-GMP materials across technical and scientific teams.

• Oversee couriers, freight forwarders, and specialized cold-chain carriers.

• Handle import/export compliance, licenses, permits, customs documentation, and specific country import requirements.

• Supervise cold-chain shipment execution, packaging qualification, investigations of temperature excursions, and corrective actions.

• Monitor shipment status, coordinate inbound/outbound logistics, resolve delays or exceptions, and maintain tracking/reporting.

• Ensure adherence to GMP, GCP, and relevant import/export regulations.

• Maintain inspection-ready documentation and file records in eTMF/quality systems.

• Support the creation and revision of SOPs.

• Lead or assist in deviation, CAPA, and investigation processes related to supply or shipping challenges.

⛳️ Requirements

• A Bachelor's degree in life sciences, supply chain, logistics, or a related discipline is required; an advanced degree is preferred.

• For the Associate Director role: typically, 10+ years of experience in the clinical supply chain within biotech or pharma.

• Direct experience in the packaging, labeling, and distribution of investigational products throughout all stages of international clinical studies.

• Experience in managing shipping, logistics, or distribution operations, including carrier/freight-forwarder management and import/export or customs compliance.

• Familiarity with IRT/RTSM systems, clinical supply forecasting tools, and CMO/depot network management.

• Experience in clinical trials related to rare diseases, cardiology, or genetic medicine is an advantage.

• Working knowledge of GMP, GCP, and global import/export regulations pertinent to clinical trial materials.

• Strong skills in vendor management, negotiation, and cross-functional collaboration.

• Ability to juggle multiple competing priorities in a fast-paced, expanding biotech setting.

• Excellent analytical, organizational, and written/verbal communication abilities.

• Comfort with the autonomy and hands-on responsibilities typical of a small, growing company.

• Some domestic and/or international travel may be necessary to support vendor, depot, or CMO site visits.

• This role is based in San Diego, CA or can be remote.

🏝️ Benefits

• Stock options & RSUs.

• 401(k) with employer match.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• LTD coverage.

• Unlimited time off, including summer & winter breaks.

• Learning and development programming.

• Job-specific industry training opportunities.

• Education reimbursement program.