Director, Clinical Supply Chain

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🕒 May 5

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Logo of Codera

Codera

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.

📋 Description

• Serve as the primary clinical supply chain contact • Provide study and site-level support (e.g., resupply requests, return and destruction management, temperature excursion management) • Manage drug supply shipments • Facilitate and oversee storage, returns, reconciliation and destruction • Monitor inventory levels, drug product expirations and resupplies • Oversee import/export licenses and customs forms • Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance • Ensure batch release dates are properly prioritized for key study timelines • Onboard and manage relationships with clinical supply chain vendors, including negotiating and reviewing agreements, resolving issues and providing financial oversight • Prepare and manage clinical supply projections • Maintain budget for supply chain operations and review and track monthly invoices from vendors against budget • Create and maintain supply chain-related Standard Operating Procedures (SOPs) and associated Forms and Plans • Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs • Ensure supply chain compliance with GxP documentation and training requirements • Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for both internal and external audits • Review and approve packaging and labeling documents and batch records • Draft vendor documentation required for receipt/shipment of clinical supplies and investigational product • Assist in the design, build and user acceptance testing of IRT system • Execute other duties as assigned

🎯 Requirements

• Bachelor’s Degree required • Minimum 5 years of experience in supply management and logistics within pharmaceutical industry required • Experience with clinical blinding practices in clinical studies • Proficient in GxP and pharmaceutical industry procedures and regulations • Understanding of systems selection, design and management • Strong organizational skills with the ability to manage projects, resources, timelines and budgets, in a fast-paced, entrepreneurial environment • Must be proficient in Microsoft Excel.

🏖️ Benefits

• comprehensive benefits package designed to support employees’ physical, mental and financial health • employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs

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