Clinical Supplies Manager

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life through clinical studies in oncology, including NSCLC and CRC. They are seeking a Clinical Supply Manager to support their clinical development pipeline and supply chain strategy.

Location: Remote (US)

Salary: $120,000—$145,000 USD

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.
• Comfortable interacting with all levels of the organization, customers, and suppliers.
• Able to work with abstract global problems.
• Nimble in a highly dynamic and agile organization where changing priorities are the norm.
• Interpersonal and communication skills.
• Organized and demonstrates effective team leadership.
• Effective with global workgroup associates.
• A promotor of inclusion and collaboration.
• Able to work independently.
• Able to handle multiple projects simultaneously while maintaining high-quality results.
• Capable of providing and implementing innovative solutions to unique and pressing situations.
• Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive/Regulation.
• Fundamental knowledge of drug development process.
• Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies.
• Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs.