Senior Director, Epidemiology

Role Summary

Senior Director, Epidemiology

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, in alignment 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, assessment of treatment patterns and unmet need, development of 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, press releases, etc.
• Oversee timely and appropriate 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), as well as in Research, Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
• Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency, quality, and impact of functional activities.

Qualifications

• Doctoral degree (e.g. PhD, ScD) and/or Master‚Äôs degree (e.g. MSc) in Epidemiology from an accredited institution, with a minimum of twelve (12) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry. A doctoral degree in epidemiology with leadership experience and primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submission and safety are preferred.
• A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different 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 practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
• Experience leading, coaching, and managing people in a global setting.
• Demonstrated 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 others across functions to ensure shared purpose and clear accountability for future decisions.
• Well-developed cross-cultural sensitivity.

Skills

• Epidemiology study design and analysis
• Real-World Evidence (RWE) generation and utilization
• Regulatory strategy and communication for RWE
• Cross-functional leadership and team management
• Strategic planning and stakeholder management
• Scientific publication and regulatory documentation
• Global collaboration across functions and geographies

Education

• PhD/ScD or MSc in Epidemiology (preferred)