Director, Safety Physician in Oxford

Reporting to the VP of Patient Safety & Pharmacovigilance (PSPV), the Safety Physician Director will oversee investigational and marketed product pharmacovigilance activities and safeguard patients enrolled in trials or receiving our products.

Role and Responsibilities

• Implement the medical review of individual case safety reports (ICSRs) to ensure quality reports and evaluate medical accuracy.
• 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 contribute to the preparation and presentation of safety information to the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other stakeholders.
• Interact and liaise with the PV vendor medical reviewer and Summit Medical Monitors.
• Review individual and aggregate safety data from the 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.
• Update the reference safety information (RSI) and maintain the expected terms list in collaboration with development partners and cross‑functional teams.
• Lead the Medical Safety Review process and support training and implementation of new processes.
• Mentor junior medical safety reviewers; provide direct managerial responsibilities for reviewers on therapeutic or functional teams.
• Maintain inspection readiness and act as the functional representative for Health Authority inspections and internal audits.
• Provide expertise and guidance on interdepartmental and cross‑functional initiatives, including process improvement, SOP creation, and metrics for medical safety review.
• Author, review, and/or approve safety content of aggregate safety summary documents such as DSURs, PBRERs, Regulatory Response documents, and Safety Signal Evaluation documents when requested.
• Perform other duties as necessary as defined in SOPs or by supervisor. All other duties as assigned.

Experience, Education and Specialized Knowledge

• MD, DO, or international equivalent with a minimum of 8+ years 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); oncologist with practical experience preferred.
• Proficiency in technical safety systems.
• Strong knowledge of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection in both clinical trials and post‑market safety.
• Experience in safety data analysis and writing study‑related narratives, aggregate reports, and safety assessments.
• Ability to work effectively in a team environment and independently.
• Experience in MedDRA coding and search strategies.
• Strong computer and database skills.
• Attention to detail, accuracy, and confidentiality.
• Clear and concise oral and written communication skills.
• Excellent organizational, critical thinking, and problem‑solving skills.
• Ability to effectively multitask and manage time‑sensitive and highly confidential documents.
• Ability to communicate complex ideas in an easily understandable way.
• Ability to work in a fast‑paced, demanding, and collaborative environment.

Compensation

$10,000 – $20,000 USD per annum (actual compensation packages may include bonus, stock, benefits and other variable components).

Equal Opportunity Employer

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