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 Director/Senior 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 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
• Minimum 5 years of experience in supply management and logistics within pharmaceutical industry
• 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 participates in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.