Director, Epidemiology

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Overview**

The Director, Epidemiology is responsible for supporting the function at Alnylam providing expertise, strategic vision, and oversight of real-world evidence (RWE) activities in support of all clinical development programs and marketed RNAi therapeutics. In this role, you will work closely with Global Patient Safety and Risk Management (GPSRM), Medical Affairs, Value Evidence and Strategy (VEST), Biostatistics, Clinical Research and Regulatory Affairs to inform clinical development and real-world outcomes 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 Data Sciences and Statistics team and reports to the Senior Director and Head, Epidemiology.   **

Key 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.  Understanding of signal evaluation techniques is required.

·    Partnering with Biostatistics and Statistical Programming to implement, provide technical oversight of analyses from natural history & other observational studies to support clinical development and scientific publications, presentations and abstracts

·    Strategic and tactical support for developing RWE external comparators including methods

·    Support regulatory submission activities including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers and helping 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

·    Partner with Medical Affairs and VEST to define evidence gaps and design and implement RWE solutions including observational studies, disease registries, and EMR/claims data. Author epidemiology sections of our global value dossiers

·    Partnering with Biostatistics and Statistical Programming to implement, provide strategic oversight of analyses from registries, post-approval safety studies and other observational studies to support regulatory requirements and scientific publications, presentations and abstracts

·    Establish real-world data partnerships in collaboration with Medical Affairs and Commercial and coordinate acquisition of real-world data to avoid duplication

·    Support the development of innovative RWE approaches, techniques, and standards to be used across teams

·    Stay current with emerging guidances from various regulatory authorities on the design of observational studies and the use of real-world data to support decision making.

·    Stay current with and adopt emerging analytical methodologies, tools and applications to ensure fit-for-purpose and innovative approaches

·    Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions

·    Ability to successfully manage priorities, resources, and performance targets

·    Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge **

Qualifications**

· Doctoral degree (e.g. PhD, MD, ScD) and/or Master’s degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Health Services or Pharmaceutical Outcomes Research, with a minimum of 5 years (PhD) or 8+ years (MS) of relevant experience. Preference for a minimum of three (3) years of that experience developing RWE strategies and/or executing epidemiology studies.

· Ability to partner successfully with multiple expertise areas and manage priorities

· Superb communication skills and ability to translate observational research methods and results for diverse audiences

· Deep understanding of observational research methods to define appropriate research questions and data sources, study design, and rigorous and fit-for-purpose analytical approaches

· Solid epidemiology and statistical skills

· Entrepreneurial attitude, to work with and through others, to reimagine the way we use data and analytics to develop and deliver RNAi therapeutics for patients

· Demonstrated track record of leading and executing research projects using real world data from claims, electronic health records, and registries including publications

· Direct experience using RWE to support early-stage clinical development, regulatory approvals, and safety commitments

· Solid understanding of the opportunities for use of RWE to inform regulatory decision makers

· Advanced knowledge in observational research design

· Flexibility and ability to adapt and support a growing portfolio of RNAi therapeutics

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About Alnylam**

Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the  RNAi Revolution  and continues to turn scientific possibility into reality. 

Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to
building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.