Director Epidemiology

The Director Epidemiology is responsible for representing the Epidemiology function at Alnylam, providing expertise, strategic vision, and oversight of epidemiology and real-world evidence (RWE) activities in support of all clinical development programs and marketed RNAi therapeutics.

In this role, you will work closely with Clinical Research, Global Patient Safety and Risk Management (GPSRM), Regulatory Affairs, and Biostatistics to inform clinical development and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies and real-world evidence.

The Director Epidemiology sits within the Quantitative Sciences team and reports to the Senior Director and Head Epidemiology. You will provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates. Guide and advise clinical development study teams on the design and collection of natural history data to better understand disease progression, including risk factors and optimal endpoints for use in clinical trials.

You will also provide strategic and tactical expertise on the development of RWE for external comparators, including advisement on the appropriate methodology for the use of RWE for regulatory purposes. Support regulatory submission activities, including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers, and provide scientific leadership on the design post-marketing commitment studies.

Investigate and understand potential safety signals for marketed RNAi therapeutics. Establish real-world data partnerships in collaboration with Medical Affairs and Commercial, and coordinate the acquisition of real-world data to avoid duplication.

Provide leadership in the development of innovative RWE approaches, techniques, and standards to be used across teams.

Requirements:

• PhD in Epidemiology or other Quantitative Public Health discipline
• Experience applying epidemiologic methods in at least one disease area, preferably using pharmacoepidemiologic techniques
• Ability to deliver complex epidemiological studies in a regulated environment with moderate supervision
• At least 5 years of experience in the pharmaceutical industry or equivalent experience in an academic or government setting
• Current knowledge of emerging guidance from various regulatory authorities on the design of observational studies and the use of real-world data to support decision-making
• Current knowledge and expertise in emerging analytical methodologies, tools, and applications to ensure fit-for-purpose and innovative approaches on the use of RWD to address pertinent questions
• Effective communication skills both at the lay and technical level to inform stakeholders on the utility of RWE across the product lifecycle and drive use of study analysis results to support internal and external decisions
• Ability to succeed in a matrixed environment with multiple stakeholders
• Ability to successfully manage priorities, resources, and performance targets
• Knowledge of private and public use datasets for the conduct of epidemiological studies
• Basic knowledge of regulatory requirements in the pharmaceutical industry
• Proficient written and communication skills