Clinical Supplies Manager

Summit Therapeutics Sub•Princeton, NJ

22d•Onsite

About The Position

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. We are seeking an experienced clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development. The Clinical Supply Manager will be responsible for planning and execution of operations for their assigned clinical supply projects and to support the ongoing development pipeline as well as optimization of Clinical Supplies department processes. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key supply chain expert for cross functional teams. Prior experience in a small to mid-sized, fast-paced pharmaceutical environment is preferred. Summit are a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times. Travelling for the role (vendor facility visits, Investigator Meetings, etc) will be required at times and is estimated to be 5-10%.

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
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

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