Associate Director – Clinical Supply Chain

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

📋 Description

• Oversee the complete clinical supply chain operations for designated international studies.

• Act as the main point of contact for clinical supply chain matters related to assigned studies.

• Provide operational assistance at the study and site levels, including facilitating resupply requests, overseeing returns and destruction, and managing temperature excursions.

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

• Lead the development of labels for assigned studies, which includes booklet label creation for international studies.

• Manage both manual and IRT-enabled drug supply shipments.

• Facilitate and supervise storage, returns, reconciliation, and destruction processes.

• Monitor inventory levels, expiration dates of drug products, and resupply needs.

• Oversee import/export licenses and ensure customs documentation is in order.

• Prioritize batch release dates in line with critical study timelines.

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

• Prepare and maintain clinical supply forecasts.

• Manage the budget for supply chain operations for assigned studies and track monthly vendor invoices against the budget.

• Ensure that clinical supply documentation is systematically organized and filed in the Trial Master File (TMF) according to SOPs.

• Engage in inspection readiness activities, ensuring the clinical supply chain is prepared for qualifications.

⛳️ Requirements

• Bachelor's degree is mandatory.

• A minimum of 6 years' experience in clinical supply management and logistics within the pharmaceutical sector is required.

• Experience with EU/international clinical trials is essential.

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

• Expertise in GxP and pharmaceutical industry standards and regulations is necessary.

• Understanding of system selection, design, and management is important.

• Strong organizational capabilities with the ability to manage projects, resources, timelines, and budgets in a dynamic environment.

• Proficiency in Microsoft Excel is required.

🏝️ Benefits

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

• Generous paid time off policy.

• Various retirement plan options available.

• Additional wellness and professional development programs offered.