Director, Epidemiology

Alnylam Pharmaceuticals•Cambridge, MA

1d•Hybrid

About The Position

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 to 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.

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

Responsibilities

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
Use real-world and clinical data to refine population size and characteristics for disease targets as clinical development progresses, in both rare disease and prevalent disease areas.
Partner with Clinical Research and GPSRM to help interpret and refine potential safety signals during drug development.
Partner with Biostatisticians and Statistical Programming to implement, provide technical oversight of analyses from natural history & other observational studies to support clinical development and the preparation of scientific publications, presentations and abstracts.
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
Partner with GPSRM to deliver and provide oversight for 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 in collaboration with Medical Affairs and Commercial and coordinate 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
Mentor junior epidemiologists and RWE/observational analysts to ensure competence in epidemiologic skills and knowledge