Project Temperature Strategy & Execution Lead – Clinical Supply Chain

About the role

The Project Temperature Strategy & Execution Lead is responsible for defining and executing temperature management strategies for clinical trial medicines, including drug products and finished kits, across all trial phases. This position acts as the subject‑matter expert on temperature excursions, passive shipper strategy, audit readiness, and continuous process improvement within a regulated clinical supply chain environment.

Key responsibilities

• Oversee temperature strategy governance across the Clinical Supply Chain and partner functions such as Quality, Drug Product Development, Global Clinical Operations, and Logistics.
• Ensure all temperature‑related activities comply with GMP, GDP, GCP, GxP, and other regulatory standards.
• Serve as the audit spokesperson and SME for temperature strategy, preparing audit materials and responding to regulatory inquiries.
• Lead the development, implementation, and optimisation of passive shipper strategies, including quote coordination, purchase‑order setup, and central sourcing.
• Maintain and update passive‑shipper documentation to guarantee audit readiness.
• Drive strategic projects using FPX and project‑management best practices to improve processes and resolve temperature‑excursion issues.
• Collaborate with cross‑functional partners to support new trials, portfolio changes, and business integrations.

Required profile

• Bachelor’s degree in Business or Science (minimum); Master’s degree or supply‑chain certification (e.g., APICS) preferred.
• Demonstrated leadership, accountability, strategic thinking, and risk‑based decision‑making in a global, regulated environment.
• Strong collaboration and communication skills with internal and external stakeholders.

Required skills

• APICS or equivalent supply‑chain certification.
• Experience with FPX or similar project‑management tools.
• Expertise in passive shipper documentation and temperature‑management processes.