Sr. Director, Global Drug Safety MD
About The Position
Neurocrine Biosciences is seeking a senior medical safety leader to provide expert medical oversight of its evolving pipeline and product safety profiles, driving proactive benefit-risk management throughout the product lifecycle. The role partners with senior leaders across Drug Safety, Clinical Development, Regulatory Affairs, Medical Affairs, and other teams to translate complex safety data into actionable insights and support science-driven patient-safety decisions. The position provides medical safety expertise for assigned marketed and/or investigational therapies; leads global safety surveillance and risk management strategies; and advises senior leadership and governance teams on safety decisions and benefit-risk considerations. It also provides medical guidance on signal management, aggregate safety reviews, and individual case safety reports; contributes to safety-related regulatory submissions and documentation; supports regulatory authority responses; and represents Drug Safety on multidisciplinary teams. The role may mentor colleagues and have responsibility for direct reports and resource management.
Requirements
- M.D. degree and an accredited residency in a relevant clinical specialty, such as Internal Medicine, Family Practice, or Neurology.
- Board certification and clinical/industry experience.
- At least 4 years of relevant experience.
- Pharmacovigilance experience in a pharmaceutical company, preferably, or a biotechnology company, including signal management such as signal detection, evaluation, and assessment.
- Deep medical and scientific expertise and comprehensive knowledge of pharmacovigilance, safety surveillance, and risk management.
- 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, including the ability to translate scientific insights into actionable recommendations and business decisions.
- Proven ability to influence senior leaders and cross-functional stakeholders.
Responsibilities
- Serve as medical safety expert for assigned marketed and/or investigational therapies, with accountability for ongoing evaluation and management of their safety profiles.
- Lead development and execution of global safety surveillance and risk management strategies to proactively identify, assess, and mitigate emerging safety concerns.
- Provide strategic medical guidance to senior leadership and cross-functional governance teams on safety decisions, benefit-risk considerations, and product lifecycle management.
- Interpret complex clinical and post-marketing safety data to drive safety strategy and decision-making.
- Provide medical guidance for signal detection, evaluation, assessment, and management, including investigation of emerging trends and potential risks.
- Lead aggregate safety data reviews and provide medical interpretation for safety surveillance and benefit-risk evaluations.
- Oversee and contribute to medical review of individual case safety reports, including seriousness, expectedness, causality, and clinical interpretation, as needed.
- Partner with pharmacovigilance and safety operations teams to ensure robust, compliant, and scientifically sound safety surveillance practices.
- 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, Investigator Brochures, Integrated Summaries of Safety, clinical protocols, and informed consent documents.
- Support responses to regulatory authority inquiries and participate in safety governance discussions.
- Develop and refine risk management strategies across development and post-approval settings in alignment with evolving regulatory expectations.
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and other stakeholders on decisions affecting product safety and patient care.
- Represent Drug Safety on multidisciplinary teams and contribute to clinical research strategies, development plans, and product lifecycle activities.
- Strengthen 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.
Benefits
- Retirement savings plan with company match.
- Paid vacation, holiday, and personal days.
- Paid caregiver/parental and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Annual bonus with a target of 35% of earned base salary.
- Eligibility to participate in an equity-based long-term incentive program.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
