Global Head, Medical Drug Safety & Pharmacovigilance

Neurocrine Biosciences • San Diego, CA

1d • $322,300 - $439,000

About The Position

This is a Global Head, Executive Director-level Drug Safety leadership role with responsibility for leading a high-performing team of safety physicians and shaping medical safety and benefit-risk strategy across Neurocrine's global development pipeline and marketed portfolio. Reporting to the Vice President, Drug Safety, the Global Head will serve as a key member of the Drug Safety leadership team and a senior safety leader across Neurocrine R&D, setting direction and deploying safety strategies across programs and throughout the product lifecycle. The role is designed for an accomplished safety leader who can connect deep pharmacovigilance expertise with broader drug development and enterprise strategy. This leader will advise senior and executive stakeholders on complex safety, development, regulatory, and portfolio decisions; represent Drug Safety in senior governance forums; and help shape the future direction, capabilities, and impact of the Drug Safety organization.

Requirements

• Industry-leading expertise in global pharmacovigilance, safety surveillance, signal detection and management, benefit-risk assessment, and risk management.
• Deep understanding of drug development and the role of medical safety from clinical development through approval and post-marketing.
• Strong knowledge of international regulatory requirements, particularly FDA and EU/EEA regulations, and pre- and post-marketing drug safety standards.
• Proficiency with safety databases and safety coding dictionaries such as MedDRA and WHODRUG; experience with ARISg is preferred.
• Exceptional analytical thinking and advanced medical judgment.
• Demonstrated ability to provide strategy, vision, and direction on issues with potential company-wide impact.
• Exceptional influencing, communication, presentation, and decision-making capabilities.
• Strong leadership capabilities with demonstrated success leading through influence across multidisciplinary teams.
• Ability to manage multiple complex programs and priorities with a high degree of accountability, accuracy, and effectiveness.

Nice To Haves

• Experience with ARISg is preferred.

Responsibilities

• Shape Portfolio Safety Strategy: Partner with the Vice President, Drug Safety to establish and advance medical safety strategy and priorities across Neurocrine's investigational and marketed portfolio.
• Provide senior medical leadership across the pipeline, identifying portfolio-level safety themes, risks, opportunities, and implications.
• Ensure safety and benefit-risk considerations are integrated into clinical development, regulatory, labeling, and portfolio strategy.
• Serve as a senior escalation point and thought partner on complex or high-impact safety matters.
• Anticipate emerging safety issues and translate complex clinical and safety data into clear recommendations for senior decision-makers.
• Serve as a Senior R&D and Executive Partner: Build trusted partnerships with senior and executive leaders across Clinical Development, Regulatory Affairs, Clinical Operations, R&D, and other functions.
• Represent Drug Safety in senior R&D leadership, governance, and decision-making forums and represent the Vice President, Drug Safety when appropriate.
• Contribute to senior governance and Management Committee discussions and preparation on safety, benefit-risk, and development strategy.
• Support safety strategy and assessments for Board and other senior governance discussions.
• Distill complex safety information into clear, decision-oriented narratives for executive, regulatory, governance, and Board-level audiences.
• Lead Medical Safety and Benefit-Risk Strategy: Guide integrated approaches to safety surveillance, signal detection and management, benefit-risk assessment, and risk management across development and marketed products.
• Support evaluation of individual and aggregate safety information to identify, investigate, and interpret potential safety signals.
• Provide senior medical and strategic leadership in interactions with global regulatory authorities, including complex safety and pharmacovigilance matters.
• Translate emerging safety information into appropriate clinical development, regulatory, labeling, and risk-management actions.
• Provide Leadership Across Drug Safety: Lead, develop, and inspire a high-performing team of safety physicians while helping shape the Drug Safety organization's strategy, culture, capabilities, talent, and ways of working.
• Build and strengthen physician safety leadership capability, coaching Safety Medical personnel and creating clear accountability for high-quality medical safety strategy and execution.
• Translate portfolio safety strategy into clear priorities and deploy medical safety approaches consistently across programs, partnering closely with multidisciplinary teams.
• Champion consistent, high-quality approaches to medical review, surveillance, signal management, benefit-risk assessment, and aggregate reporting.
• Represent Neurocrine externally with regulatory authorities, collaborators, partners, and other stakeholders, as appropriate.
• Own people leadership, talent development, performance, and resource allocation for the physician safety team, aligning capabilities and capacity to the evolving needs of the pipeline.
• Maintain Excellence in Medical Safety: Provide senior medical oversight of individual and aggregate safety data, including medical review, signal evaluation, and benefit-risk assessment.
• Support or contribute to safety-related regulatory submissions and periodic reports, including DSURs, IND Annual Reports, PADERs, PBRERs, PSURs, and responses to regulatory inquiries.
• Ensure scientific rigor, consistency, and quality of medical safety assessments across Neurocrine programs.

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Executive