Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
About the Role:
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.
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Your Contributions (include, but are not limited to):
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.
Requirements:
The Leader We Are Looking For
We are looking for a senior safety leader who brings deep pharmacovigilance expertise together with broad drug development perspective and executive-level judgment. You can move seamlessly between detailed safety science and enterprise strategy; anticipate and frame complex benefit-risk decisions; influence across functions and levels; and communicate credibly with development teams, executive leadership, regulators, and Board-level stakeholders. You think beyond individual programs, develop other leaders, and understand how medical safety can help shape broader development and portfolio decisions.
Knowledge and Qualifications
- 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.
Typical Experience or Education
- M.D degree plus accredited residency in relevant clinical specialty (eg Internal Medicine, Family Practice, Neurology) and Board certification and clinical/industry experience.
- 6-10+ years of experience in pharmacovigilance in a pharmaceutical or biotechnology company. This includes leadership experience in signal management (e.g., signal detection, evaluation, assessment), clinical development, medical review of safety reports, and filings and responses to regulatory safety inquiries.
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Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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The annual base salary we reasonably expect to pay is $322,300.00-$439,000.00. 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.