Director, Clinical Supply Chain IRT

Summit Therapeutics•Princeton, NJ

3d•$203,000 - $253,000•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. 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. Location: Princeton, NJ ONSITE Overview of Role: We are seeking a highly motivated, solutions-oriented Director, Clinical Supply Chain IRT to lead the development, implementation, and continuous improvement of IRT standards across clinical development programs. This is a high-impact role for a top performer who thrives in a dynamic biotech environment, can operate strategically and hands-on, and is able to translate complex clinical, operational, and supply chain requirements into clear standards, robust processes, and effective system solutions. The Director, Clinical Supply Chain IRT will serve as the subject matter expert and process owner for IRT standards and related ways of working. The role will partner closely with Clinical Supply Chain, Clinical Operations, Quality, IT, external vendors, and study teams to deliver fit-for-purpose IRT solutions that support efficient study start-up, reliable execution, compliant change management, and scalable clinical supply operations.

Requirements

Bachelor’s degree in life sciences, supply chain, pharmacy, or a related discipline; advanced degree preferred
Significant experience (10+ years) in Clinical Supply Chain, Clinical Operations, IRT/RTSM, or a closely related clinical development function within the pharmaceutical, biotechnology, or CRO environment
Strong working knowledge of IRT/RTSM design, testing, UAT, change control, and study implementation processes
Experience developing technical standards, SOPs, process documentation, risk assessments, and training materials
Demonstrated ability to operate effectively in a fast-paced, cross-functional, and matrixed biotech environment
Proven ability to influence stakeholders, manage competing priorities, and drive high-quality outcomes with minimal oversight
Strategic thinker with strong operational execution capability
Excellent written and verbal communication skills, with the ability to simplify complex information for diverse audiences
Strong process mindset with a focus on scalability, compliance, governance, and continuous improvement
High attention to detail and commitment to quality, inspection readiness, and documentation excellence
Collaborative leadership style with the ability to build credibility across internal and external stakeholders
Self-directed, adaptable, and comfortable working through ambiguity in a growing biotech environment

Responsibilities

Lead development and process improvement activities within and across teams, including knowledge-sharing sessions, training forums, and targeted information sessions
Provide expert consultancy to internal and external stakeholders on study-specific IRT solutions, process development, program strategy, and practical options to meet evolving program needs
Act as process owner for IRT processes and sub-processes, ensuring they remain clear, compliant, efficient, and scalable
Set the standard for excellence in IRT setup, change management, and cross-functional delivery, while modelling the values, behaviors, and performance expectations required in a dynamic biotech environment
All other duties as assigned