Associate Director/Director, Clinical Supply Chain (EU)

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Associate Director/Director, Clinical Supply Chain will lead end-to-end clinical supply chain operations for assigned international studies. This role is responsible for supply planning, forecasting, packaging, labeling, and distribution management, as well as the oversight of key supply chain vendors — including shipping and logistics providers, clinical supply depots, and IRT vendors — from study start-up through close-out, while partnering closely with internal stakeholders to ensure clinical materials are available and that study strategies, timelines, and budgets are met.

The ideal candidate brings extensive experience managing European and Rest of World (RoW) operations, including booklet label development, the Qualified Person (QP) release process, import/export logistics, and cold chain management.

Essential Duties and Responsibilities

• Serve as the primary clinical supply chain contact for assigned studies
• Provide study- and site-level operational support, including resupply requests facilitation, returns and destruction oversight, and temperature excursion management
• Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance
• Lead label development efforts for assigned studies, including booklet label development for international studies
• Manage manual and IRT-enabled 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
• Ensure batch release dates are properly prioritized for key study timelines
• Review and approve packaging and labeling documents and batch records
• Prepare and manage clinical supply projections
• Maintain budget for supply chain operations for assigned studies and review and track monthly invoices from vendors against budget
• Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs
• Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for

Qualifications

• Bachelor’s Degree required

• Minimum 6 years of experience in clinical supply management and logistics within pharmaceutical industry required
• Experience with EU/international clinical studies required
• Experience with clinical blinding practices in clinical studies preferred
• 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 environment
• Must be proficient in Microsoft Excel

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.

The estimated annual base salary for this position is $140,000 - $220,000, commensurate with experience and skills.

Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness andprofessional development programs.

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.

Salary: $140,000 - $220,000