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 VP of Patient Safety Pharmacovigilance (PSPV), the Safety Physician Director will be responsible for investigational and marketed product pharmacovigilance activities.

Responsibilities

include medical review of individual case safety reports (ICSRs), strategic input for adverse event monitoring and signal detection, ensuring global pharmacovigilance regulatory

: Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Evaluate medical accuracy of ICSRs reports. Prepare Analysis of Similar Events (AOSE) for IND safety reports.

g. SUSAR or urgent safety issues). Lead or actively contribute to the preparations and presentation of safety information to the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal and external stakeholders/parties, when required.

Interact and liaise with PV vendor medical reviewer and Summit Medical Monitors. Review individual and aggregate safety data from safety database on a scheduled basis for signal detection. Act as product lead and/or therapeutic area lead as assigned.

Share ICSR case quality issues with PV Operations as appropriate, and support Quality Assurance of ICSR medical review. Implement appropriate case follow up / queries per SOPs. Develop and support medical coding conventions, and systematic process improvements for ICSR medical review.

Support reconciliation between Safety and Clinical databases. Develop, maintain, update, review and approve list of expected terms via the Reference Safety Information (RSI) in the IB, in collaboration with development partner and cross-functional teams.

Requirements

are met, and safeguarding patients enrolled in our trials or administered our products.

Director, Safety Physician