Senior Director, Epidemiology

Role Summary

The Senior Director, RWE Product Lead is accountable for the development and execution of the Real-World Evidence (RWE) strategy in support of one or more Inflammation products under development. This role serves as the key RWE subject-matter expert within the Global Development Team for the product(s) and indications across the development lifecycle, partnering with clinical development, medical, and commercial teams to ensure excellence in the generation and use of RWE at the global level. The role leads a team of observational research scientists and ensures timely, high-quality RWE for internal and external stakeholders, including regulators, while advising on methodological approaches for payer and provider interactions.

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 the timely execution of the RWE strategy, aligned with the clinical development plan and broader GDT objectives.
• Provide the 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, but not limited to: natural history of disease, population characterization, treatment patterns and unmet need, external comparators, benchmarking of clinical 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/analysis 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 other communications.
• Oversee development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
• Represent the RWE function in internal cross-functional initiatives and external organizations, such as industry associations, professional societies, or 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 evidence needs of regulators, payers, providers, and patients.
• Identify the need for process development or enhancements in training documents to increase efficiency, quality, and impact of functional activities.

Qualifications

• Required: Doctoral degree (e.g., PhD, ScD) and/or Master’s degree (e.g., MSc) in Epidemiology from an accredited institution, with a minimum of 12 years of post-graduate experience; preference for at least 6 years in the biopharmaceutical industry.
• Preferred: Doctoral degree in epidemiology with leadership experience and primary focus on epidemiology evidence generation for clinical development support, regulatory submission, and safety.
• Required: A 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.
• Required: Understanding of the Inflammation therapeutic area, including disease knowledge, current treatment practices and guidelines, relevant trial endpoints, and safety outcomes.
• Required: Experience leading, coaching, and managing people in a global setting.
• Required: Ability to operate with autonomy and develop productive cross-functional collaborations.
• Required: Ability to manage priorities, resources, and performance targets in a changing environment.
• Required: Strong communication across functions to ensure shared purpose and clear accountability for decisions.
• Required: Well-developed cross-cultural sensitivity.

Education

• PhD, ScD, or MSc in Epidemiology or closely related field.