Title: Senior Manager, Clinical Supply Chain
Location: Marlborough, MA, 01752
Duties: Responsible for managing drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials.
Skills: Lead and manage end-to-end Clinical Supply Chain activities (planning, packaging and labeling, distribution, returns and destruction) for assigned clinical programs in early and late phases. Develop and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC. Manage IP inventory levels at the depots and clinical sites; coordinate the inventory from manufacturer to depot or clinical sites. Design and/or review label text to meet product requirements and ensure compliance with US and international regulations. Ensures effective management of IP based on study timing and in accordance with clinical protocols, cGMP, Google Cloud Platform, ICH, FDA, and other applicable international, federal, and/or local regulations. Collaborate closely with Clinical Operations, CMC, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs; ensure supplies readiness. Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export; work closely internal Trade Compliance & Logistics team. Demonstrates a solid understanding of clinical study design (randomized, blinded, open label etc.) and execution. Manage assign clinical trial contracts, purchase orders including invoices and budget for clinical supply vendor; participate in CSC budget and forecast planning. Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
Education: BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
Minimum 5-7 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.
At least 3+ years in Clinical Supplies Management. Proficient knowledge of Microsoft Excel, PowerPoint, and Project software required.
APICS certification (CPIM, CLTD, CSCP) preferred.
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