Sr. Director, Global Drug Safety MD
Neurocrine Biosciences
Summary
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.
Job description
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.
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
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.