Senior Director of Supply Chain

Our client, a virtual, clinical-stage oncology biopharmaceutical company, has engaged GForce Life Sciences to provide a full-time Clinical & Commercial Supply Chain Consultant. This individual will report to the VP of Manufacturing & Technical Operations and will support global clinical supply operations while maintaining commercial supply readiness activities. The immediate priority is continuity of clinical drug supply across an ongoing global Phase 2 oncology program, including oversight of external vendors, depots, shipments, inventory and product release coordination.

The company operates with a lean, fully remote team and an outsourced supply chain model. The clinical program is conducted under a master protocol with four subprotocols and approximately 80-90 sites across the U.S., U.K., Europe, Asia and Australia. The consultant will work closely with Clinical Operations and may interface with Regulatory Affairs and Quality Assurance. Existing systems and processes are established;

the immediate need is to assume day-to-day ownership and maintain continuity rather than redesign operations.

• Own day-to-day clinical supply operations for a global Phase 2 oncology trial, ensuring investigational product is available at the appropriate depots and clinical sites.
• Manage clinical supply vendors and outsourced partners, including depots, couriers, packaging/labeling providers and other supply chain service providers.
• Monitor IRT system activity, depot inventory levels and shipment activity; identify and resolve supply needs and discrepancies.
• Coordinate and track shipments of clinical supplies to global depots and sites, following through with vendors to ensure timely delivery.
• Coordinate product release activities, including QP release requirements for applicable global markets, to enable distribution.
• Maintain appropriate inventory levels across depots and sites while supporting a lean inventory model and avoiding unnecessary excess product.
• Partner with Clinical Operations to anticipate trial activity, site requirements, enrollment changes and upcoming supply needs.
• Review clinical trial requirements and update drug supply forecasts and projections as needed.
• Support ongoing clinical supply planning and the DNOP process.
• Maintain established supply chain processes and SOPs; recommend improvements when appropriate without disrupting ongoing trials.
• Provide continuity of commercial supply readiness activities, including commercial supply operations planning, as needed.
• Support commercial launch preparation activities, including 3PL setup/management, labeling and serialization implementation, where applicable.
• Support supply setup for new studies or subprotocols as clinical development plans evolve.

• Bachelor's degree in a life sciences, health-related or equivalent field.
• Demonstrated experience managing clinical supply operations within the pharmaceutical or biotechnology industry.
• Hands-on experience managing clinical supply vendors, depots, shipments and global distribution for clinical trials.
• Working experience with IRT systems and clinical site/depot inventory management.
• Experience coordinating clinical drug release and global supply requirements, including QP release processes where applicable.
• Ability to independently manage day-to-day clinical supply activities in an outsourced operating model.

• 15-20 years of relevant pharmaceutical/biotechnology supply chain experience; candidates with fewer years may be considered if they bring directly relevant depth.
• Experience with the current IRT platform (Civica/Civota, as referenced during the discussion); specific platform experience is preferred but not required.
• Experience with clinical and commercial supply planning, including DNOP and supply operations planning processes.
• Commercial launch-readiness experience, including 3PL implementation/management, commercial labeling and serialization.
• Experience supporting global clinical trials across the U.S., U.K., Europe, Asia and Australia and experience supporting oncology clinical development programs.

• Start ASAP
• Potential to convert to a permanent position for the right individual.
• Fully remote, East Coast time-zone alignment is preferred