About the role
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 - $220,000Originally posted on Himalayas