Director, Safety Physician

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)

-
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:

Reporting to the Vice President, Patient Safety & Pharmacovigilance (PSPV), the Director, Safety Physician is responsible for pharmacovigilance activities for investigational and marketed products. This role provides medical oversight of individual case safety reports (ICSRs), contributes strategically to adverse event monitoring and signal detection, supports compliance with global pharmacovigilance regulatory requirements, and helps protect patients participating in clinical trials or receiving company products. The role also provides safety-related medical input and guidance across the organization, as requested by the VP of PSPV.
Role and Responsibilities:
- Lead the medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments, to ensure high-quality and medically accurate reports.

- Prepare Analyses of Similar Events (AOSEs) to support IND safety reports.

- Confirm criteria and content for expedited safety reporting and unblinding decisions, including SUSARs and urgent safety issues.

- Lead or actively contribute to the preparation and presentation of safety information for the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal or external stakeholders, as needed.

- Review study protocols, including Sponsored Study, Investigator-Sponsored Trial, and Collaborative Study protocols for accuracy of safety-related content, and for assessment of overlapping toxicities with approved or investigational agents used in combination with Summit compounds.

- Interact and liaise with pharmacovigilance vendor medical reviewers and company Medical Monitors.

- Review individual and aggregate safety data from the safety database on a scheduled basis to support signal detection.

- Serve as product lead and/or therapeutic area lead, as assigned.

- Identify and communicate ICSR case quality issues to PV Operations, as appropriate, and