Senior Director, Epidemiology

Role Summary

Senior Director, Epidemiology responsible for developing and executing the RWE strategy in support of one or more Inflammation products. Acts as the key RWE subject-matter expert within the Global Development Team across the development lifecycle and partners with clinical development, medical, and commercial teams to ensure excellence in the generation and use of real-world evidence. Oversees a team of observational research scientists and ensures timely, high-quality, and impactful RWE to meet internal and external needs, including regulatory considerations.

Responsibilities

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development and post-authorization evidence requirements for a specific product and its pipeline/lifecycle indications in Inflammation.
• Ensure the use of robust scientific methods and fit-for-purpose data resources for timely execution of the RWE strategy, aligned with the clinical development plan and broader GDT objectives.
• Provide functional perspective and subject-matter expertise, especially regarding regulatory use of RWE, as a member of the product GDT.
• Lead a team of observational research scientists to deliver, within time, budget, and quality standards, proactive RWE generation including natural history of disease, population characterization, treatment-pattern assessment, development of external comparators, benchmarking of outcomes, comparative safety and effectiveness research, and post-approval safety studies.
• Communicate effectively about the utility of RWE across the product lifecycle and drive use of study results to support internal and external decisions.
• Ensure expert communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers, and related materials.
• Oversee development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, designations, Pediatric Investigation Plan, query responses, briefing documents).
• Represent the RWE function in internal cross-functional initiatives and external organizations (industry associations, professional societies, regulatory working groups).
• Foster close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics) and with Research, Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet regulator/payer/provider/patient evidence needs.
• Identify and develop processes or training materials to increase efficiency, quality, and impact of functional activities.

Qualifications

• Doctoral degree (e.g., PhD, ScD) or Master’s degree (e.g., MSc) in Epidemiology from an accredited institution, with a minimum of twelve (12) years post-graduation experience; preference for at least six (6) years in the biopharmaceutical industry. Doctoral degree with leadership experience and a focus on epidemiology evidence generation, especially for clinical development support, regulatory submission, and safety, is preferred.
• Strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with various applications of RWE, especially in support of early-stage clinical development and regulatory approvals.
• Demonstrated understanding of the Inflammation therapeutic area, including disease knowledge, current treatment practices and guidelines, relevant clinical trial endpoints, and safety outcomes.
• Experience leading, coaching, and managing people in a global setting.
• Ability to function with a high level of autonomy and develop productive cross-functional collaborations.
• Ability to manage priorities, resources, and performance targets in a changing environment.
• Ability to communicate proactively with colleagues across functions to ensure shared purpose and clear accountability for future decisions.
• Well-developed cross-cultural sensitivity.

Skills

• Expertise in epidemiologic study design and real-world evidence generation across product development stages.
• Strong leadership and people management skills in a global organization.
• Strategic thinking with ability to translate scientific evidence into regulatory, payer, and market access implications.
• Excellent collaboration and communication skills across clinical, medical, regulatory, and commercial functions.

Education

• Doctoral degree (PhD/ScD) or Master’s degree (MSc) in Epidemiology from an accredited institution.