About the Role:In this highly visible role, you will serve as a strategic medical safety leader, providing expert medical oversight of our evolving pipeline and safety profiles driving proactive benefit-risk management throughout the product lifecycle.
You will partner closely with senior leaders across Drug Safety, Clinical Development, Regulatory Affairs, Medical Affairs, and other cross-functional teams to translate complex safety data into actionable insights, inform critical decisions, and ensure a comprehensive, science-driven approach to patient safety.
This opportunity is well suited for a physician with strong pharmacovigilance expertise who enjoys balancing hands-on medical and scientific evaluation with strategic leadership, cross-functional influence, and meaningful product ownership.
Your Contributions (include, but are not limited to):Product Safety Strategy & Medical Leadership
- Serve as the medical safety expert for assigned marketed and/or investigational therapies, with accountability for the ongoing evaluation and management of their safety profiles
- Lead the development and execution of global safety surveillance and risk management strategies, ensuring proactive identification, assessment, and mitigation of emerging safety concerns
- Provide strategic medical guidance to senior leadership and cross-functional governance teams on safety-related decisions, evolving benefit-risk considerations, and product lifecycle management
- Drive safety strategy and decision-making through the interpretation of complex clinical and post-marketing safety data
Pharmacovigilance & Signal Management
- Provide medical guidance for signal detection, evaluation, assessment, and management activities, including the investigation of emerging safety trends and potential risks
- Lead aggregate safety data reviews and provide medical interpretation to support ongoing safety surveillance and benefit-risk evaluations
- Oversee and contribute to the medical review of individual case safety reports, including seriousness, expectedness, causality assessments, and clinical interpretation, as needed
- Partner with pharmacovigilance and safety operations teams to ensure robust, compliant, and scientifically sound safety surveillance practices
Regulatory Strategy & Safety Governance
- Provide medical oversight and strategic input into safety-related regulatory submissions and periodic safety reports, including DSURs, PBRERs, PSURs, PADERs, and IND Annual Reports, as applicable
- Contribute to safety-related regulatory documentation, including product labeling, Company Core Data Sheets (CCDS), Investigator Brochures, Integrated Summaries of Safety, clinical protocols, and informed consent documents
- Support responses to regulatory authority inquiries and participate in safety governance discussions to inform product-level decisions
- Develop and refine risk management strategies across development and post-approval settings, ensuring alignment with evolving regulatory expectations
Cross-Functional Collaboration & Organizational Leadership
- Act as a trusted medical safety partner to Clinical Development, Regulatory Affairs, Medical Affairs, and other key stakeholders, influencing decisions that impact product safety and patient care
- Represent Drug Safety on multidisciplinary teams, contributing to clinical research strategies, development plans, and ongoing product lifecycle activities
- Provide leadership in strengthening safety surveillance processes, operational practices, and organizational capabilities
- Mentor and guide safety professionals and cross-functional colleagues, with potential responsibility for direct reports and resource management
Requirements:- M.D. degree plus accredited residency in a relevant clinical specialty (e.g., Internal Medicine, Family Practice, Neurology)
- Board certification and clinical/industry experience required
- 4+ years of relevant experience
- Experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company, with experience in signal management (e.g., signal detection, evaluation, assessment)
- Recognized thought leader with deep medical and scientific expertise and comprehensive knowledge of pharmacovigilance, safety surveillance, and risk management
- Demonstrated ability to evaluate complex safety data, apply sound medical judgment, and develop practical strategies to address emerging safety concerns
- Strong strategic thinking and problem-solving skills, with the ability to translate scientific insights into actionable recommendations and business decisions
- Proven ability to influence senior leaders and cross-functional stakeholders while
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The annual base salary we reasonably expect to pay is $292,600.00-$399,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
