Sr. Director, Epidemiology and RWE Analytics

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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Your Contributions (include, but are not limited to):

• Observational Research, RWE, and Epidemiology

  • Lead epidemiological studies to provide evidence supporting reimbursement evaluation, post-marketing safety surveillance, and clinical development.

  • Design, conduct, and interpret epidemiology studies to inform decision-making throughout the product lifecycle.

  • Ensure rigorous epidemiological methodologies are applied in the collection and analysis of real-world data.

• Quantitative HEOR Support:

  • Provide quantitative support and analysis for HEOR initiatives, enhancing the credibility and impact of economic evaluations.

  • Collaborate with HEOR teams to develop models and analyses that demonstrate the value, cost-effectiveness, and budget impact of products.

• HTA and Reimbursement Support:

  • With expertise in data and analytics, partner with HEOR teams to shape strategies to support health technology assessments (HTA) and reimbursement submissions.

  • Engage with key stakeholders, including HEOR, market access, to advocate for favorable reimbursement outcomes.

  • Integrate RWE and epidemiological data into reimbursement dossiers to support product value arguments.

• Cross-Functional Collaboration:

  • Partner with clinical development, DSPV (Drug Safety and Pharmacovigilance), medical affairs, HEOR, commercial teams, and other departments to align epidemiology and RWE activities with broader business objectives.

  • Partner with DSPV to conduct epidemiological research and projects to further understand any potential risks including epidemiological background rates as needed.

  • Provide epidemiologic input into regulatory and risk management reports such as PBRERs/PADERS, labeling, REMS / Enhanced Pharmacovigilance Plans and Health Authority requests

  • Ensure seamless communication and cooperation between departments to optimize data utilization and impact.

• Policy and Evidence Influence:

  • Stay abreast of international epidemiological and RWE trends, policy changes, and best practices to ensure alignment with global standards.

  • Represent the organization at external forums, conferences, and meetings to influence policy and reimbursement standards.

• Oversees the responsible area, including the day-to-day management activities as well as technical leadership and coaching for the staff

• Provides input and support to the development of clinical plans, publications, and studies under the direction of senior Analytics and Data Sciences (ADS) leadership

• Researches, develops, and implements statistical or observational research methods appropriate to study design and objectives and consistent with current regulatory standards and requirements

• Participates in regulatory submission planning, including data submission strategies and integrated summaries

• Represents Neurocrine as the functional representative in discussions and meetings with regulatory agencies

• Develops functional processes and procedures, including the writing and review of department standard operating procedures

• Makes final decisions on administrative or operational matters related the functional or expertise group under supervision and ensures effective achievement of objectives

• Performs other duties as assigned

Requirements:

• Masters degree in Epidemiology, Public Health, Health Economics, or a related field, and 13+ years experience in epidemiology, real-world evidence, health economics, or related fields within the biopharmaceutical industry or academic settings. Demonstrated track record of successfully leading epidemiological studies, RWE projects, and HEOR analyses.

• PhD in Epidemiology, Public Health, Health Economics or related discipline preferred and 10+ years of similar experience noted above

• Technical Skills:

  • Proficiency in epidemiological methods, observational study design, and statistical analysis.

  • Strong understanding of health economics and outcomes research (HEOR) methodologies, including cost-effectiveness and budget impact analysis.

  • Experience with health technology assessments (HTA) and reimbursement processes.

  • Knowledgeable of pharmacovigilance regulations and risk management documents and experience supporting pharmacovigilance department

• Leadership and Strategy:

  • Proven ability to provide strategic direction and thought leadership in epidemiology and RWE.

  • Strong leadership, mentoring, and team development skills.

• Communication and Collaboration:

  • Exceptional interpersonal and communication skills, with the ability to present complex data to internal and external stakeholders clearly and persuasively.

  • Ability to work cross-functionally, fostering collaboration between multiple departments.

• Industry Knowledge: In-depth knowledge of pharmaceutical industry regulations, payer landscapes, and market access strategies.

• Problem-Solving and Innovation:

  • Advanced analytical thinking and problem-solving capabilities, with a focus on continuous improvement and innovative approaches.

  • Ability to translate complex scientific findings into actionable insights.

• Demonstrated experience with handling multiple projects at one time and directing resources appropriately to address frequent changes in priorities

• Exhibits ability to become company-wide advisor and emerging industry expert

• Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals

• Must be self-motivated, detail-oriented, decisive

• Ability to quickly learn and think independently

• Ability to work with a team of individuals to meet organizational goals

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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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