The Role:
Moderna is seeking a highly skilled and experienced Director-level Epidemiologist to support our Norovirus vaccine program. A PhD in epidemiology and experience in vaccine development or infectious diseases is highly preferred, equivalent experience will be considered. The candidate will join a dynamic team of epidemiologists at the forefront of mRNA vaccine/therapeutic development. The role will focus on Norovirus but with exposure to other vaccines across the Moderna pipeline.
The Infectious Disease Epidemiology group supports a broad network of internal stakeholders across multiple functional areas through evidence generation and synthesis regarding Norovirus. Major points of focus include designing and implementing epidemiological studies, analyzing data, and providing scientific leadership to advance our norovirus vaccine development efforts.
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:
- Contribute to the development and execution of the Epidemiology strategy in support of Norovirus vaccines.
- 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 statistical software and methodologies to ensure robust data analysis.
- Provide epidemiologic expertise for product development, pre-clinical, clinical, safety, and regulatory affairs teams, contributing to the integrated evidence plans for Norovirus vaccines.
- Support design and execution of pre- and potentially post-marketing epidemiology studies, including burden of disease studies, literature reviews and gap analyses, mathematical modeling, and post-marketing safety, effectiveness, and impact studies, as needed.
- Provide epidemiologic expertise and data for 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.
- Set the scientific direction of studies and develop protocols, data analysis plans, and study reports to support the Norovirus vaccines portfolio.
- Present findings to 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 Norovirus 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.
- Develop collaborations with external experts and investigators to facilitate epidemiologic data generation activities.
- Develop and maintain strong, collaborative relationships with the broader Moderna organization.
- Provide mentorship and guidance to junior epidemiologists and other team members, fostering a collaborative and innovative team environment.
- Provide epidemiologic support to other Moderna epidemiology programs as needed.
Here’s What You’ll Bring to the Table:
- PhD in Epidemiology or related field is preferred, equivalent relevant experience will be considered. Preference given to candidates with previous experience in vaccine development or infectious diseases.
- Minimum 3 years’ experience in an industry setting, preferably in vaccines or a related therapeutic area. 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.