Clinical Supply Chain Manager

Role Summary

The Clinical Supply Chain Manager will provide global program direction and subject matter expertise in clinical trial material supply management, overseeing planning and execution of outsourced activities and coordinating with internal and external partners to ensure quality, timelines, and budget alignment.

Responsibilities

• Interact effectively with internal stakeholders across Clinical Operations, Clinical Development, Program Management, Drug Product Development and Manufacturing, Analytical Development and Quality Control, Quality Assurance, Regulatory Affairs, Strategic Sourcing and Vendor Management, and external partners.
• Develop and maintain clinical trial material study/program forecasts and supply plans in collaboration with functional groups, CROs, and CTM vendors.
• Oversee labeling and packaging operations for clinical trial materials; support deviation investigations and CAPAs in partnership with QA.
• Manage distribution, return, destruction, inventory, expiry tracking, and export/import requirements for clinical trial materials.
• Coordinate over-labeling date extension activities.
• Oversee direct-to-patient plans for clinical studies.
• Lead development of global label text and translations for clinical studies with internal teams and external vendors.
• Contribute to the development of clinical trial IRTs by providing material requirements and performing user acceptance testing.
• Manage budget and scope related to the clinical trial material supply chain.
• Collaborate with internal and external stakeholders to achieve goals and maintain clear records of all activities.
• Manage and execute personnel qualification and training programs.

Qualifications

• BS/BA in science or related field; minimum 5 years of hands-on experience in clinical trial material supply management in the biopharmaceutical industry.
• Hands-on experience with global IRT systems and conducting placebo-controlled trials.
• Experience with CDMOs/CROs in clinical trial material supply and with global partners.
• Knowledge of managing early and late phase clinical trial material supply; familiarity with regulatory requirements.
• Highly organized with strong attention to detail and documentation skills.
• Strong communication and follow-up skills; ability to work independently and with cross-functional teams.
• Ability to work flexible hours to communicate with global partners (up to 20%).

Skills

• Clinical supply chain management
• Forecasting and supply planning
• Labeling, packaging, and QA collaboration
• Inventory management and regulatory compliance
• Vendor management and IRT development
• Budget and project management

Education

• BS/BA in science or related field