Job Description

Senior Director, Safety Science (Patient Safety and Pharmacovigilance)

Join Summit Therapeutics to lead safety science for our innovative investigational antibody, Ivonescimab (SMT112), a bispecific targeting PD?1 and VEGF, currently in Phase III trials for non?small cell lung cancer. Summits first?in?class therapeutic is rapidly advancing through global clinical programs under FDA Fast Track designation.

Key Phase III Clinical Programs

• HARMONi Phase III study of Ivonescimab + chemotherapy vs. placebo + chemotherapy in EGFR?mutated advanced NSCLC.
• HARMONi?3 Phase III study of Ivonescimab + chemotherapy vs. pembrolizumab + chemotherapy in first?line metastatic NSCLC.
• HARMONi?7 Phase III study of Ivonescimab monotherapy vs. pembrolizumab monotherapy in first?line metastatic NSCLC with high PD?L1 expression.

Role Overview

The Senior Director of Safety Science will develop and execute strategic safety plans, manage signal detection and risk management initiatives, and ensure global regulatory compliance across all marketing and clinical activities.

Role and Responsibilities

• Establish a signal management system and oversee signal detection activities.
• Collaborate effectively with cross?functional teams and external partners.
• Analyze safety data from toxicology, pre?clinical, clinical, post?approval, and literature sources.
• Prepare presentations and communicate safety concerns to internal and external audiences, including DSC, IDMC, and executive committees.
• Manage literature review plans for investigational and marketed products.
• Lead completion, authoring, and submission of periodic safety reports (DSUR, PADER, PBRER).
• Prepare and review safety sections of regulatory documents (IB, RSI justification, protocols, ICFs, CRFs).
• Support creation of regional product labels and company core data sheets.
• Plan and coordinate tables, figures, and listings for CSRs and other submissions.
• Write, medically review, and QC safety narratives in CSRs.
• Develop and review risk?management plans.
• Manage Pharmacovigilance System Master File (PSMF) with QPPV officer.
• Determine safety topics for DSC meetings; schedule, host, and prepare slides.
• Lead development and implementation of safety SOPs, tools, and policies.
• Support PV audits and inspections; act as subject?matter expert during regulatory inspections.
• Ensure global regulatory compliance for SAEs, signal management, and risk management.
• Manage Safety Science scientists.
• Perform additional duties as assigned.

Experience, Education, and Skills

• MD, PharmD, PhD, or MSN.
• 7+ years of drug safety experience or related regulatory industry experience.
• Comprehensive knowledge of domestic and international safety reporting and pharmacovigilance requirements.
• Proficiency in signal detection and risk?management tools.
• Experience in oncology drug development (highly desirable).
• Strong computer and database skills.
• Exceptional written and verbal communication skills.
• Excellent organizational and critical?thinking abilities.
• Ability to manage multiple projects and prioritize competing demands.
• Confidentiality, attention to detail, and ability to work independently.

Pay Range: $240,000$285,000 annually, plus bonus, stock, and benefits.

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