Summit Therapeutics, Inc. · 6 hours ago
Clinical Supplies Manager
Summit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life and addressing serious medical needs. They are seeking an experienced Clinical Supplies Manager to oversee supply chain strategy for clinical development, ensuring effective planning, vendor management, and compliance with regulatory standards.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Clinical Trial Supply Planning and Forecasting
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
Vendor Management
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
Inventory Management
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)
Regulatory Compliance
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
Risk Management
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
Communication and Collaboration
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
Qualification
Required
Bachelor's degree in a relevant scientific or business discipline
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
Intuitive with well-honed 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
Able to demonstrate a 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
Preferred
Prior experience in a small to mid-sized, fast-paced pharmaceutical environment
Advanced degree preferred
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Recent News
The Motley Fool
2026-01-13
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