Senior Specialist, Clinical Supply Chain

icines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Independently support global clinical supply chain operations across multiple studies. This role is ideal for a detail-oriented, proactive professional who thrives in a fast-paced environment and can manage study-level supply planning, execution, and vendor coordination with minimal oversight.
• Independently manage clinical supply chain activities for assigned studies, including planning, execution, and reconciliation.
• Support global depot and site distribution, including coordination of Qualified Person (QP) release, import/export logistics, and temperature-controlled shipments.
• Lead clinical label design, packaging, and labeling activities in collaboration with internal teams and external vendors.
• Serve as the primary point of contact for CMOs, depots, and IRT vendors for assigned studies.
• Develop and maintain study-level supply plans and forecasts, adjusting for protocol amendments, enrollment trends, and country/site activation.
• Manage IRT system setup and maintenance, including drug assignment logic, inventory thresholds, and expiry management.
• Monitor and manage IP inventory across depots and sites, ensuring timely resupply and minimizing waste.
• Track and resolve temperature excursions, deviations, and other supply-related issues in collaboration with QA and vendors.
• Maintain study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout.
• Collaborate cross-functionally with Clinical Operations, QA, Regulatory, and Project Management to ensure alignment and timely execution.
• Archive documentation on Trial Master Files as required.

Required Skills, Experience and Education:
• B.S. in a scientific or supply chain-related field.
• 3-6 years of experience in clinical supply chain and logistics, GMP manufacturing, Quality Assurance, or related pharmaceutical/biotech environment.
• Direct experience in production documentation review (MBRs, executed batch records, deviations, change controls), batch disposition and release processes, and QP certification of IMPs (Investigational Medicinal Products) and/or commercial products.
• Demonstrated experience supporting global clinical trials, including import/export logistics.
• Strong working knowledge of clinical packaging/labeling requirements and temperature-controlled distribution.
• Proficiency in Microsoft Excel. Veeva Quality Management System experience is a plus.
• Experience with oncology trials and complex study designs is a plus.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively across functions and with external partners.

Preferred Skills:
• Strong attention to detail and ability to critically review complex GMP documentation.
• Prior experience working within a Quality organization strongly preferred.
• Experience interacting with CMOs/external manufacturing partners.

#LI-Hybrid #LI-CT1