Regulatory Program Management Director
Posted 18 Sep 2026
Advertised as “Director, Regulatory Program Management ”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 6+ yrs
- Management level
- People management
- Employment
- Remote
No salary listed for this role.
CertificationsBachelor’s Degree, Master of Business Administration
About Summit:
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)
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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.
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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.
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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
The Director, Regulatory Program Management (RPM), provides strategic and operational leadership for high-priority, complex regulatory filings and submissions across the product portfolio. This role drives alignment across Research, Development, Regulatory Affairs, Manufacturing, and execution teams to ensure regulatory objectives are delivered with clarity, rigor, and accountability.
The Director partners closely with Regulatory Affairs, Medical Writing, Program Leadership, and cross-functional development teams to translate portfolio and regulatory strategies into executable plans. The role serves as a key contact for executive leadership and supports disciplined governance and strengthens the Program Management function as the organization scales.