Director, Safety Physician

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

👔 Director

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Report to the VP of Patient Safety & Pharmacovigilance (PSPV) • Perform medical review of individual case safety reports, including narratives, coding, expectedness, causality and seriousness • Evaluate medical accuracy of ICSR reports • Prepare Analysis of Similar Events (AOSE) for IND safety reports • Confirm criteria and content for expedited reporting and unblinding, including SUSARs and urgent safety issues • Lead or contribute to safety information preparation and presentation for the Drug Safety Committee, Product Safety Review Team, Independent Data Monitoring Committees, and other stakeholders • Liaise with PV vendor medical reviewers and Summit Medical Monitors • Review individual and aggregate safety data on a scheduled basis for signal detection • Act as product lead and/or therapeutic area lead as assigned • Share ICSR quality issues with PV Operations and support quality assurance of ICSR medical review • Implement case follow-up and queries according to SOPs • Develop and support medical coding conventions and process improvements for ICSR medical review • Support reconciliation between Safety and Clinical databases • Maintain, update, review and approve expected-term lists via Reference Safety Information in the Investigator’s Brochure • Lead Medical Safety Review processes and support development, training and implementation of new processes • Mentor junior medical safety reviewers and provide direct managerial responsibilities as applicable • Maintain inspection readiness and serve as point of contact for health authority inspections and internal process audits • Provide expertise for cross-functional initiatives, including process improvement, standards development, SOP creation and medical safety metrics • Author, review and/or approve safety content for DSURs, PBRERs, regulatory response documents and safety signal evaluation documents • Perform other duties as defined in SOPs or requested by the supervisor

🎯 Requirements

• MD/DO or international equivalent • 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, including immunotherapy and chemotherapy • Proficiency in technical safety systems • Strong knowledge of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection in clinical trials and post-market safety • Experience in safety data analysis and writing study-related narratives, aggregate reports and safety assessments • 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 multitask and manage time-sensitive and highly confidential documents • Ability to communicate complex ideas clearly • Ability to prioritize conflicting demands • Ability to work in a fast-paced, demanding and collaborative environment

🏖️ Benefits

• Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation • Equal Opportunity Employer