Senior Director, Epidemiology

Senior Director, Epidemiology

Apply locations Cambridge, Massachusetts Clinical Development time type Full time posted on Posted 3 Days Ago time left to apply End Date: February 28, 2025 (30+ days left to apply) job requisition id R17293

The Role:

Moderna is seeking a highly experienced Epidemiologist to develop the epidemiologic strategy and execute activities to lead its COVID-19 program. This includes developing and maintaining post-marketing commitments for COVID-19 already approved as well as the epidemiological strategy for COVID-19 vaccines in Moderna’s pipeline. A PhD in epidemiology is preferred along with ≥10 years of industry experience, preferably within vaccine development or infectious diseases. The candidate will join a dynamic team of epidemiologists at the forefront of mRNA vaccine/therapeutic development.

Moderna’s Epidemiology team supports a broad network of internal stakeholders across multiple functional areas through evidence generation and synthesis. Major points of focus include designing and implementing epidemiological studies, analyzing data, and providing scientific leadership to advance our respiratory vaccine development.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines. The candidate must have excellent oral and written communication skills and a collaborative mindset. The ability to thrive in a fast-paced and dynamic work environment is essential.

Here’s What You’ll Do:

• Accountable for the leadership, development, and execution of the Epidemiology strategy for COVID (product and team lead).
• Provide epidemiologic input to the product development, pre-clinical, clinical, safety, and regulatory affairs teams, contributing to the integrated evidence plans for COVID vaccines.
• Support the design and execution of pre- and post-marketing epidemiology plans, including burden of disease studies, literature reviews and gap analyses, mathematical modeling, and post-marketing safety, effectiveness, and impact studies, as needed.
• Set the scientific direction and develop protocols, data analysis plans, study reports and peer-reviewed publications to support COVID vaccines.
• Actively contribute to the development of Target Product Profiles, particularly in terms of demonstrating burden of disease/unmet medical need and shaping post-licensure plans.
• Serve as a key partner with Medical Affairs, Commercial, and HEOR teams in terms of market-shaping activities, including collaboration on health economic models.
• Develop collaborations with external experts and investigators to facilitate epidemiologic data generation activities.
• Provide epidemiologic support to other Moderna vaccine programs as needed.
• Develop and maintain strong, collaborative relationships within the broader Moderna organization.
• Work closely with cross-functional teams, including clinical development, biostatistics, regulatory affairs, and external partners, to ensure alignment and integration of epidemiological data into the vaccine development program.
• Analyze epidemiological data to generate insights on disease burden, transmission dynamics, and vaccine impact. Utilize methodologies to ensure robust data analysis.
• Present findings to a diverse audience of internal and external stakeholders.
• Lead or contribute to epidemiology content for regulatory submission documents; interact with regulatory agencies and other external authorities as needed.
• Contribute to epidemiologic knowledge of COVID in the external environment via abstracts, manuscripts, and presentations at academic conferences.
• Contribute to the culture of quality and methodologic rigor in the design and execution of epidemiologic activities to the highest standard of quality and compliance.
• Oversee direct reports.
• Provide mentorship and guidance to junior epidemiologists and other team members, fostering a collaborative and innovative team environment.

Here’s What You’ll Need:

• PhD in Epidemiology is preferred; related field and equivalent relevant experience will be considered.
• ≥10 years’ experience in an industry setting, preferably in vaccines or a related therapeutic area. Preference given to candidates with previous experience in vaccine development, infectious diseases, and particularly COVID or other respiratory viruses. Proven ability to:
• • Plan and execute epidemiologic studies and related activities.
  • Deliver high-quality results within established timelines.
  • Demonstrated track record in leading cross-functional teams and work streams.
• Proficiency in epidemiological study design, data analysis, and use of large electronic healthcare databases (e.g., EHR, administrative/claims data).
• Creative problem-solver with the ability to thrive in a fast-paced environment.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Excellent analytical, problem-solving, and strategic planning skills.
• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and Moderna team members across functions in a matrix environment.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of global regulatory authorities, ICH GCP, and GPP/GEP guidelines; prior interaction with major regulators and public health agencies is preferred.
• This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.