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. Summit’s 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. Summit’s team is inspired to touch and help change lives through Summit’s 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 China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Associate Director of Clinical Supply provides leadership and direction to plan and execute global clinical supply activities, ensuring timely and compliant delivery of clinical trial material (CTM) and investigational medicinal product (IMP). This position leads clinical supply planning and operations across demand and supply planning, inventory visibility, release and logistics readiness, vendor oversight, analytics, and continuous improvement. Additionally, this role partners with cross-functional stakeholders to develop and communicate supply strategies, timelines, budgets, and performance insights. Role and Responsibilities:
Clinical Supply Planning & Demand
Under the direction of the Director, manage clinical supply manufacturing, distribution and storage activities supporting global clinical trials and other research and development needs; coordinate, procure, and manage CTM/IMP supply for the Ivonescimab program. - Establish and maintain a regular review cadence for supply plans against demand forecasts and confirmed orders; lead recurring demand and supply reconciliation meetings, identify short-term constraints, and present mitigation plans. - Manage bulk and packaged inventory and track/reconcile inventory across manufacturing, packaging, depots, and clinical sites. - Coordinate upstream transport operations between suppliers and distribution warehouse(s) to support CTM/IMP supply, as needed. - Manage supply forecasts (creation, updates, cancellations) and communications in alignment with supplier agreements; review KPIs with suppliers and schedule regular governance/steering meetings. Maintain inspection readiness through robust documentation workflows and archival of CTM/IMP supply documentation for the Trial Master File (TMF). - Stakeholder Management & Partnership
Liaise with Summit Program Management to build supply and demand plan for all pipeline activities; own, disseminate and amend as required. - Partner with internal stakeholders and external suppliers to develop and communicate manufacturing and distribution plans, ensuring clinical supply objectives are supported. - Interface with Quality Assurance (QA) and Qualified Person (QP) functions to plan release activities and facilitate timely disposition and release of CTM/IMP for further processing and shipment. - Work closely with the Distribution/Logistics function to plan, document, and execute global cross-border supply strategies, including controlled substances and global trade compliance requirements. - Coordinate with Program Management and Regulatory teams; serve as the owner of bulk CTM/IMP supply plans and timelines to ensure all product-availability prerequisites are met. - Operational Excellence and Continuous Improvement
Ensure end-to-end inventory visibility, including management of material movements, utilization, expiry, returns, reconciliation, and destruction processes, leveraging appropriate systems and controls. - Manage and oversee strategic and operational Clinical Supply Operations activities, driving standardization, analytics, and continuous improvement. - Provide visibility of priorities to optimize QA/QP and regulatory release activities and support logistics and manufacturing operations, including coordination of expedited shipments when required. - Evaluate and propose system improvements and technology enhancements; roll out and strengthen key IT systems to support supply planning and partner with IT to automate demand and supply data flows across systems. Evaluate current processes, identify and implement improvement opportunities, and embed standard business processes across the Clinical Supply function. - Define needs for data analytics capabilities to enable data-driven insights across Clinical Supply; develop reporting and metrics (weekly/monthly as needed) to drive continuous improvement against key performance measures internally and with vendors. - Create and manage reporting metrics and provide visibility to operations performance through report creation, insights, and analysis of system dashboards. - Leadership
Support annual budget planning through detailed cost-of-goods analysis and supplier-level cost updates. - Coach and mentor/line-manage more junior staff; lead workstreams supporting departmental initiatives and goals; manage specialised or high-profile projects; and serve as backup to the Director, as needed. - All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
Degree in Pharmacy, Engineering other scientific/technical degree, or significant job-related experience. - Minimum of 8+ years of relevant pharmaceutical industry and/or contract/service provider experience (preferred). - Minimum 5+ years of relevant supply chain planning experience
Background in biological product manufacture is preferred
Strong understanding of cGMP requirements and regional regulatory drivers
Proficiency in software applicable to demand planning/forecasting and proficiency with Excel and MS Project (or equivalent project management software) is a plus. - Line management experience is preferred
