Senior Director, Epidemiology

This role is considered Virtual.

Overview

The Senior Director, Epidemiology is responsible for leading and developing this function at Alnylam, providing expertise, strategic vision, and oversight of real-world data (RWD) and real-world evidence (RWE) activities in support of Development and Regulatory needs, and collaborating with HEOR on RWE activities for market access needs, for all clinical development programs and marketed RNAi therapeutics. Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE.  The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.   

Key Responsibilities

• Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates
• Use real-world and clinical data to refine population size and characteristics for disease targets as clinical development progresses  
• 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 RWD to inform clinical trial design (e.g., impact of inclusion/exclusion criteria, diversity target/plan, expected rates in control arm)
• Innovative use of RWD to demonstrate value of Alnylam RNAi therapies including use of external or synthetic control arms, tokenization to add to the breadth, depth, and length of data from clinical trial participants, and leveraging fit-for-purpose RWD and OLE data to demonstrate long-term effectiveness
• Partner with Clinical Research and GPSRM to help contextualize potential safety signals during drug development
• Partner with GPSRM to design, deliver and provide strategic oversight for REMS, risk management plans and post-approval safety studies.  Author epidemiology sections of DSURs and PRBERs.  Investigate and contextualize potential safety signals for marketed RNAi therapeutics
• Support regulatory submission activities including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers, informing disease epidemiology to support waivers for PIP/PSP, and helping design post-marketing commitment studies 
• Partner with Medical Affairs (including HEOR) and Biostatistics to design and implement RWE solutions including observational Phase 4 studies and disease registries. Coordinate Epidemiology use of EMR/claims data for Development and Regulatory needs with HEOR use of EMR/claims data for Medical Affairs and Commercial needs. 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 HEOR and Commercial and coordinate acquisition of RWD to avoid duplication
• Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions
• Drive the development of RWE approaches, techniques, and standards to be used across teams
• Stay current with and adopt emerging analytical methodologies, tools and applications to ensure fit-for-purpose and innovative approaches
• Stay current with emerging guidance from various regulatory authorities on the design of observational studies and the use of RWD to support decision making  
• Responsible for recruiting, retaining, managing, and mentoring other epidemiologists and RWE analysts
• Actively manage internal and external resources to ensure a nimble and motivated team and efficient, high-quality, on-time deliverables.
• 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 Outcomes Research or Biostatistics, with a minimum of 10 years (PhD) or 12 years (MS) of relevant experience. Preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
• Excellent leadership skills
• 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
• Flexibility and ability to adapt and support a growing portfolio of RNAi therapeutics

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 culture: 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 one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 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.