Director, Safety Physician

🕒 August 25

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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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

• Provide medical oversight of individual case safety reports (ICSRs) for investigational and marketed products. • Contribute strategically to adverse event monitoring and signal detection. • Support compliance with global pharmacovigilance regulatory requirements. • Lead medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments. • Prepare Analyses of Similar Events (AOSEs) for IND safety reports. • Confirm criteria and content for expedited safety reporting and unblinding decisions, including SUSARs and urgent safety issues. • Prepare and present safety information for safety committees, monitoring committees, and stakeholders. • Review study protocols for safety content and overlapping toxicities. • Liaise with pharmacovigilance vendor medical reviewers and Medical Monitors. • Review individual and aggregate safety data to support signal detection. • Lead assigned product or therapeutic areas. • Identify ICSR quality issues and support quality assurance activities. • Implement case follow-up and query activities according to SOPs. • Develop medical coding conventions and process improvements. • Support reconciliation between Safety and Clinical databases. • Maintain and approve expected terms in Reference Safety Information. • Lead Medical Safety Review processes and support training and implementation. • Mentor and manage Safety Physicians and Medical Safety Reviewers as assigned. • Maintain inspection readiness and act as contact for health authority inspections and internal audits. • Provide expertise for process improvement, standards, SOPs, and medical safety metrics. • Author, review, or approve aggregate safety documents including DSURs, PBRERs, regulatory responses, and safety signal evaluations.

🎯 Requirements

• MD, DO, or international equivalent with a minimum of 10 years of relevant experience as a safety physician. • Working knowledge of case management and medical review processes and procedures. • Clinical knowledge of oncology patient populations and relevant drug classes, including immunotherapy and chemotherapy; oncology experience is preferred. • Proficiency with safety database systems, strong computer skills including spreadsheet and signal detection programs. • Strong understanding of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection for clinical trial and post-marketing safety. • Experience analyzing safety data and writing study-related narratives, aggregate reports, and safety assessments. • Experience working effectively independently and in cross-functional team environments. • Experience with MedDRA coding and search strategies. • High level of attention to detail, accuracy, and confidentiality. • Clear, concise oral and written communication skills. • Excellent organizational, critical thinking, and problem-solving skills. • Ability to manage multiple priorities, including time-sensitive and highly confidential documents. • Ability to communicate complex ideas clearly and effectively to varied audiences. • Ability to prioritize competing demands. • Ability to work successfully in a fast-paced, demanding, and collaborative environment.