Senior Specialist, Clinical Supply Chain

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.

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, preferably in a biotech or pharmaceutical environment.

• Demonstrated experience supporting global clinical trials, including EU QP release and import/export logistics.

• Strong working knowledge of IRT systems, clinical packaging/labeling, and temperature-controlled distribution.

• Proficiency in Microsoft Excel. Tableau and/or PowerBI 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:

• Experience maintaining clinical supply plans, enrollment projections, and distribution models to support complex study designs, including cohort expansion and global site activation strategies.

• Excellent project management and communication skills with the ability to manage multiple concurrent studies, prioritize competing timelines, and effectively communicate supply status and risks to stakeholders and leadership teams.

• Skilled in managing interactive response technology (IRT/IXRS) systems, including supply strategy configuration, inventory monitoring, shipment management, and reconciliation activities.

• Experience overseeing external vendors, depots, and packaging organizations, including performance management, issue escalation, change control coordination, and operational governance.

• Experience working in a fast-paced, growth-stage biotechnology organization. 

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