Senior Manager, Clinical Supply Chain

$143,400 - $169,000/Yr

Dainippon Sumitomo Pharma - Topeka, KS

Full-time - Mid Level

Topeka, KS

About the position

Sumitomo Pharma Co., Ltd. is seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Clinical Supply Chain. This role is pivotal in managing drug supply planning, inventory control, and distribution activities related to clinical supplies across multiple clinical programs. The Senior Manager will be responsible for overseeing label and pack scheduling, issue resolution, change implementation, vendor oversight, and scope review. The position requires close collaboration with various departments including CMC, Regulatory Affairs, Quality Assurance, and Clinical Operations, as well as external partners and CMOs, to build strong working relationships and support study project teams. The ultimate goal is to ensure timely availability of Investigational Product (IP) for clinical trials. The Senior Manager will lead and manage end-to-end Clinical Supply Chain activities, which include planning, packaging and labeling, distribution, returns, and destruction for assigned clinical programs in both early and late phases. This involves developing and managing supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC teams. Additionally, the role requires managing IP inventory levels at depots and clinical sites, coordinating inventory from manufacturers to depots or clinical sites, and ensuring compliance with US and international regulations regarding label text and product requirements. Effective management of IP based on study timing and adherence to clinical protocols, cGMP, GCP, ICH, FDA, and other applicable regulations is crucial. The Senior Manager will also coordinate with the Commercial Supply Chain for the use of commercial products in clinical trials, manage clinical supply logistics, and resolve issues such as shipment delays and temperature excursions. Furthermore, the role includes developing and managing clinical trial IRT systems, participating in process improvement initiatives, and managing clinical trial contracts and budgets. The Senior Manager will represent the Clinical Supply Chain function at clinical trial meetings and will be responsible for managing, mentoring, and developing staff as required.

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 US and international regulations.
• Ensure effective management of IP based on study timing and in accordance with clinical protocols, cGMP, GCP, ICH, FDA, and other applicable regulations.
• Collaborate closely with Clinical Operations, CMC, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs.
• Coordinate with Commercial Supply Chain for use of commercial products in clinical trials.
• Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export.
• Develop and manage clinical trial IRT systems, including specification development and User Acceptance Testing (UAT).
• Participate in process improvements initiatives contributing to clinical supply chain; 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 including invoices and budget for clinical supply vendor.
• Participate in CMO audits and/or technical visits as required.
• Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
• 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

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• Unlimited paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter