Hybrid Clinical Supplies Manager

at Summit Therapeutics, Inc.

• Job title: Clinical Supplies Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $118,500 - $139,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Miami, United States

About the role

• Clinical Supplies Manager supporting the supply chain strategy for clinical development in biopharmaceutical oncology. Overseeing planning and execution of clinical supply projects and optimizing processes.

Responsibilities

• Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections.
• Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones.
• Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centres, and courier services.
• Monitor vendor performance, adherence to timelines, and quality standards.
• Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain.
• Ensure adequate and timely supply of investigational products to clinical sites.
• Oversee the planning, implementation and utilisation of effective clinical systems to support inventory management and distribution (e.g. IxRT).
• Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management.
• Support regulatory strategy by overseeing provision of required documentation for submission and QP certification as required.
• Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
• Identify potential risks and challenges in the clinical supply chain and develop mitigation plans.
• Proactively address issues that may impact the availability of clinical trial materials.
• Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments.
• Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns.
• Contribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topics.
• All other duties as assigned.

Requirements

• Bachelor's degree in a relevant scientific or business discipline; advanced degree preferred.
• Minimum 5 years experience in Supplies management at a pharma, biotech or contract development and manufacturing organization (CDMO)
• Proficiency in relevant software applications (e.g., Microsoft Office, clinical trial management systems).
• Demonstrated track record of successfully managing complex international clinical studies and supply chains.
• Broad understanding of regulatory and GMP requirements for IMP product packaging and supply.
• Solid understanding and experience in design specifications and UAT of IXRS applications.
• Project management skills, tools, principles, and applications
• Expertise in outsourcing and supplier management
• Proficiency with clinical supply planning and forecasting tools