Director, Epidemiology

Alnylam Pharmaceuticals•Cambridge, MA

2d•Remote

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 supporting 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 using observational studies and RWE. The position is part of the Quantitative Sciences team and reports to the Senior Director and Head, Epidemiology. The Director provides epidemiologic leadership across natural history research, population assessment, safety signal evaluation, regulatory submissions, post-marketing studies, and RWE partnerships. The role also develops innovative RWE approaches and standards and mentors junior epidemiologists and observational 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 ensure fit-for-purpose, innovative approaches to real-world data.
Effective communication skills at both lay and technical levels to explain the utility of RWE across the product lifecycle and promote use of study and analysis results in 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 disease-target incidence and prevalence through literature reviews, database analysis, or extrapolation of estimates.
Advise clinical development study teams on designing and collecting natural history data to understand disease progression, risk factors, and optimal clinical trial endpoints.
Use real-world and clinical data to refine the size and characteristics of disease 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.
Support clinical development and preparation of scientific publications, presentations, and abstracts.
Provide strategic and tactical expertise on developing RWE for external comparators, including advising on appropriate methods for regulatory use.
Support regulatory submissions, including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers.
Provide scientific leadership on the design of post-marketing commitment studies.
Partner with GPSRM to deliver and oversee REMS, risk management plans, and post-approval safety studies.
Author epidemiology sections of DSURs and PRBERs.
Investigate and understand 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 development of innovative RWE approaches, techniques, and standards for use across teams.
Mentor junior epidemiologists and RWE/observational analysts to build epidemiologic competence and knowledge.