Director, Clinical Supply Chain

📋 Description

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

• Offer support at both study and site levels (e.g., handling resupply requests, managing returns and destruction, overseeing temperature excursions).

• Coordinate and manage shipments of drug supplies.

• Supervise and facilitate storage, returns, reconciliation, and destruction processes.

• Keep track of inventory levels, monitor drug product expiration dates, and manage resupply needs.

• Oversee the import/export licenses and customs documentation.

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

• Ensure that batch release dates are prioritized according to critical study timelines.

• Establish and maintain relationships with clinical supply chain vendors, including negotiating and reviewing contracts, resolving issues, and providing financial oversight.

• Prepare and manage projections for clinical supply needs.

• Maintain the budget for supply chain operations while reviewing and tracking monthly vendor invoices against the budget.

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

• Organize and file clinical supply documentation in accordance with SOPs within the Trial Master File (TMF).

• Ensure compliance of the supply chain with GxP documentation and training obligations.

• Engage in inspection readiness initiatives, ensuring the clinical supply chain is prepared for both internal and external audits.

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

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

• Assist in the design, development, and user acceptance testing of the Interactive Response Technology (IRT) system.

• Perform other duties as assigned.

⛳️ Requirements

• Bachelor’s Degree is mandatory.

• At least 5 years of experience in supply management and logistics within the pharmaceutical sector is required.

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

• Proficient understanding of GxP and pharmaceutical industry regulations and procedures.

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

• Strong organizational abilities, capable of managing projects, resources, timelines, and budgets in a dynamic, entrepreneurial setting.

• Proficiency in Microsoft Excel is required.

🏝️ Benefits

• Comprehensive benefits package aimed at supporting employees' physical, mental, and financial well-being.

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

• Generous paid time off policy.

• Options for retirement plans.

• Additional wellness initiatives and professional development programs.