Director, Epidemiology
About The Position
The Director, Epidemiology represents the Epidemiology function at Alnylam, providing expertise, strategic vision, and oversight of epidemiology and real-world evidence (RWE) activities in support of clinical development programs and marketed RNAi therapeutics. The role works closely with Clinical Research, Global Patient Safety and Risk Management (GPSRM), Regulatory Affairs, and Biostatistics to inform clinical development and address product- and disease-area research questions through observational studies and real-world evidence. The position is part of the Quantitative Sciences team and reports to the Senior Director and Head, Epidemiology. The Director provides epidemiological and RWE leadership throughout the product lifecycle, including assessment of disease burden, guidance on natural history research, support for clinical and regulatory decisions, and oversight of safety-related studies and submissions. The role also establishes real-world data partnerships, advances RWE methods and standards, and mentors junior epidemiologists and analysts.
Requirements
- PhD in Epidemiology or another 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 regulatory-authority guidance on observational study design and the use of real-world data to support decision-making.
- Knowledge and expertise in emerging analytical methodologies, tools, and applications to develop fit-for-purpose and innovative approaches using real-world data.
- Effective communication skills at both lay and technical levels to explain RWE’s utility across the product lifecycle and drive use of study and analysis results in internal and external decisions.
- Ability to succeed in a matrixed environment with multiple stakeholders.
- Ability to manage priorities, resources, and performance targets.
- Knowledge of private and public-use datasets for epidemiological studies.
- Basic knowledge of pharmaceutical industry regulatory requirements.
- Proficient written and communication skills.
Nice To Haves
- Ophthalmology experience is highly preferred.
Responsibilities
- Assess the incidence and prevalence of disease targets using literature reviews, database analyses, or extrapolation of estimates.
- Advise clinical development study teams on designing and collecting natural history data to understand disease progression, risk factors, and appropriate clinical trial endpoints.
- Use real-world and clinical data to refine the size and characteristics of target populations as clinical development progresses across rare and prevalent disease areas.
- Partner with Clinical Research and GPSRM to interpret and refine potential safety signals during drug development.
- Partner with Biostatisticians and Statistical Programming to implement and provide technical oversight of analyses from natural history and other observational studies, supporting clinical development and scientific publications, presentations, and abstracts.
- Provide strategic and tactical expertise on developing real-world evidence for external comparators, including advising on appropriate methodologies for regulatory use.
- Support regulatory submissions, including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers, and provide scientific leadership for post-marketing commitment study design.
- Partner with GPSRM to deliver and oversee REMS, risk management plans, and post-approval safety studies.
- Author epidemiology sections of DSURs and PRBERs and investigate potential safety signals for marketed RNAi therapeutics.
- Establish real-world data partnerships with Medical Affairs and Commercial and coordinate data acquisition to avoid duplication.
- Lead the development of innovative RWE approaches, techniques, and standards for use across teams.
- Mentor junior epidemiologists and RWE/observational analysts to build epidemiologic skills and knowledge.
Benefits
- Annual short-term incentive award, such as a bonus or sales incentive.
- Annual long-term incentive award, such as equity.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- Lifestyle reimbursement program.
- Flexible spending and health savings accounts.
- 401(k) with a generous company match.
- Paid time off, wellness days, and holidays.
- Two company-wide recharge breaks.
- Family resources and leave.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
