Senior Manager, Clinical Supply Chain

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview 

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Clinical Supply Chain. The Senior Manager, Clinical Supply Chain is 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.  

Job Duties and Responsibilities 

• 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, GCP, 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. 

• Coordinate with Commercial Supply Chain for use of commercial products used in clinical trial. 

• Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export; work closely internal Trade Compliance & Logistics team. 

• Develop and manage clinical trial IRT systems, including specification development and User Acceptance Testing (UAT) and day to day management of IRT. 

• Participate in process improvements initiatives contributing to clinical supply chain; develop/implement Clinical Supply Chain SOPs as necessary. 

• 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. 

• Participate in CMO audits and/or technical visits as