Director, Clinical Supply Chain

About Codera 

Codera is a Tang Capital company that provides in-house end-to-end drug development 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 Director, Clinical Supply Chain will support clinical supply chain operations for all Codera-managed domestic and international studies, including but not limited to clinical drug supply planning and forecasting, clinical packaging, labelling and distribution management, inventory management and oversight of supply chain vendors. This individual will manage
vendors (e.g., shipping and logistics vendors, clinical supply depots and Interactive Response Technology (IRT) vendors) from study start-up through close-out. This role will closely interface with internal stakeholders and third parties to ensure clinical material and supplies are available and clinical study strategies, timelines and budgets are adhered to. 

Essential Duties and Responsibilities 

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 

Qualifications 

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

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 $190,000 - $250,000, 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 and professional 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.