Director, Clinical Supply Chain

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

📋 Description

• Act as the main point of contact for the clinical supply chain.

• Provide support at the study and site level, including managing resupply requests, return and destruction processes, and temperature excursion oversight.

• Oversee the shipment of drug supplies.

• Facilitate and monitor storage, returns, reconciliation, and destruction activities.

• Track inventory levels, monitor drug product expiration dates, and manage resupply efforts.

• Manage import/export licenses and customs documentation.

• Create and implement global inventory supply plans in collaboration with Technical Operations, Clinical Operations, and Quality Assurance.

• Ensure that batch release dates align with critical study timelines.

• Establish and maintain relationships with clinical supply chain vendors, including negotiation and agreement review, issue resolution, and financial oversight.

• Prepare and oversee clinical supply projections.

• Maintain the budget for supply chain operations and review monthly vendor invoices against the budget.

• Develop and uphold supply chain-related Standard Operating Procedures (SOPs) along with associated Forms and Plans.

• Ensure that clinical supply documentation is well-organized and filed in accordance with the Trial Master File (TMF) requirements, as per SOPs.

• Guarantee compliance with GxP documentation and training standards within the supply chain.

• Participate in preparation for inspections, ensuring readiness for both internal and external audits related to the clinical supply chain.

• Review and approve packaging and labeling documents as well as batch records.

• Draft necessary vendor documentation for the receipt and shipment of clinical supplies and investigational products.

• Assist in the design, development, and user acceptance testing of the IRT system.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s Degree is required.

• A minimum of 5 years of experience in supply management and logistics within the pharmaceutical industry is required.

• Experience with clinical blinding practices in clinical studies is essential.

• Must possess proficiency in GxP and pharmaceutical industry procedures and regulations.

• Understanding of systems selection, design, and management is necessary.

• Strong organizational abilities with a capacity to manage projects, resources, timelines, and budgets in a fast-paced, entrepreneurial environment.

• Proficiency in Microsoft Excel is mandatory.

🏝️ Benefits

• Comprehensive benefits package aimed at supporting employees’ physical, mental, and financial health.

• Employer-sponsored insurance plans that include medical, dental, and vision coverage.

• Generous paid time off policy.

• Options for retirement plans.

• Additional wellness and professional development programs.