Sr. Director – Epidemiology and RWE Analytics

Sr. Director – Epidemiology and RWE Analytics

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
• 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
• Proven ability to provide strategic direction and thought leadership in epidemiology and RWE.
• Strong leadership, mentoring, and team development skills.
• Exceptional interpersonal and communication skills, with the ability to present complex data to internal and external stakeholders clearly and persuasively.
• In-depth knowledge of pharmaceutical industry regulations, payer landscapes, and market access strategies.
• Advanced analytical thinking and problem-solving capabilities, with a focus on continuous improvement and innovative approaches.
• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• Oversee the responsible area, including the day-to-day management activities as well as technical leadership and coaching for the staff.
• Provide input and support to the development of clinical plans, publications, and studies under the direction of senior Analytics and Data Sciences (ADS) leadership.
• Research, develop, and implement statistical or observational research methods appropriate to study design and objectives and consistent with current regulatory standards and requirements.
• Participate in regulatory submission planning, including data submission strategies and integrated summaries.
• Represent Neurocrine as the functional representative in discussions and meetings with regulatory agencies.
• Develop functional processes and procedures, including the writing and review of department standard operating procedures.
• Make final decisions on administrative or operational matters related to the functional or expertise group under supervision and ensure effective achievement of objectives.
• Perform other duties as assigned.

Preferred Qualifications

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