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. 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 HARMONi, HARMONi-3, HARMONi-7, and HARMONi-GI3, evaluating ivonescimab in various lung and colorectal cancer settings.

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. Primary responsibilities include medical review of individual case safety reports (ICSRs), strategic input for adverse event monitoring and signal detection, ensuring global pharmacovigilance regulatory requirements are met, and safeguarding patients enrolled in our trials or administered our products.

Role and Responsibilities

• Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.
• Prepare Analysis of Similar Events (AOSE) for IND safety reports.
• Confirm criteria and content for expedited reporting and unblinding (e.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), and Independent Data Monitoring Committees (IDMCs).
• 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 and support Quality Assurance of ICSR medical review.
• Develop and support medical coding conventions and systematic process improvements.
• 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.
• Mentor junior medical safety reviewers and provide direct managerial responsibilities for therapeutic or functional teams.
• Maintain a state of inspection readiness and act as functional representative for Health Authority Inspections.
• Author, review and/or approve safety content of aggregate safety summary documents such as DSURs, PBRERs, and Regulatory Response documents.

Experience, Education and Specialized Knowledge and Skills

• MD/DO or international equivalent plus a minimum of 8+ years relevant work as a safety physician.
• Working knowledge of case management and medical review processes and procedures.
• Clinical knowledge of oncology therapeutic area patient populations and drug classes (immunotherapy and chemotherapy).
• Proficiency in technical safety systems.
• Strong knowledge of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection.
• Experience in safety data analysis and writing study related narratives and aggregate reports.
• Experience in MedDRA coding and search strategies.
• Excellent organizational, critical thinking, and problem-solving skills.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.