Senior Manager, Clinical Supply Chain

$143,400 - $169,000/Yr

Dainippon Sumitomo Pharma - Oklahoma City, OK

Full-time - Senior

Oklahoma City, OK

About the position

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe, focused on addressing patient needs in various therapeutic areas including oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. The Senior Manager, Clinical Supply Chain is a pivotal role responsible for overseeing the entire clinical supply chain process, ensuring that investigational products (IP) are available for clinical trials in a timely and compliant manner. This position requires a dynamic and highly motivated individual with extensive experience in clinical supply management, project management, and collaboration with various stakeholders including Clinical Operations, CMC, Regulatory Affairs, and Quality Assurance. The Senior Manager will lead and manage end-to-end clinical supply chain activities, which include planning, packaging, labeling, distribution, returns, and destruction of clinical supplies for assigned programs. This role involves developing and managing supply forecasts and plans in collaboration with clinical teams, ensuring that inventory levels are maintained at depots and clinical sites, and coordinating the logistics of IP from manufacturers to these locations. The Senior Manager will also be responsible for ensuring compliance with regulatory requirements, managing clinical trial contracts and budgets, and participating in audits and technical visits as necessary. In addition to these responsibilities, the Senior Manager will mentor and develop staff, participate in process improvement initiatives, and represent the Clinical Supply Chain function at clinical trial meetings. This role is critical in supporting study project teams and ensuring that clinical programs advance smoothly and efficiently, ultimately contributing to the company's mission of bringing novel therapies to patients sooner.

Responsibilities

• Lead and manage end-to-end Clinical Supply Chain activities for assigned clinical programs.
• Develop and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC.
• Manage IP inventory levels at depots and clinical sites; coordinate inventory from manufacturer to depot or clinical sites.
• Design and/or review label text to meet product requirements and ensure compliance with regulations.
• Ensure effective management of IP based on study timing and in accordance with clinical protocols and regulations.
• Collaborate closely with Clinical Operations, CMC, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs.
• Coordinate with Commercial Supply Chain for the use of commercial products in clinical trials.
• Manage clinical supply and logistics and resolve issues such as shipment delays and temperature excursions.
• Develop and manage clinical trial IRT systems, including specification development and User Acceptance Testing (UAT).
• Participate in process improvement initiatives and develop/implement Clinical Supply Chain SOPs as necessary.
• Demonstrate a solid understanding of clinical study design and execution.
• Manage assigned clinical trial contracts, purchase orders, and budget for clinical supply vendors.
• Participate in CMO audits and/or technical visits as required.
• Represent Clinical Supply Chain function at clinical trial meetings and communicate plans to stakeholders.
• Manage, mentor, and develop staff as required.

Requirements

• BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
• Minimum 8-12 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.

Benefits

• 401(k) plan participation
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Unlimited paid time off
• 11 paid holidays
• 80 hours of paid sick time upon hire and each year thereafter
• Merit-based salary increases
• Short incentive plan participation
• Additional time off for a shut-down period during the last week of December.