Director, Global Safety Epidemiology

The Role:

Moderna is seeking an epidemiologist to lead, shape, and execute quantitative strategies for safety signal identification, refinement, and evaluation with real world data.  A PhD in epidemiology and experience in development and conduct of post-authorization safety studies 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 both safety topics and Risk Management Plan-defined areas of missing information across the Moderna pipeline.

The Global Safety Epidemiology group supports a broad network of internal stakeholders across multiple functional areas through evidence generation and synthesis concerning safety topics. Major points of focus include epidemiologic support of pharmacovigilance, design and conduct of post-authorization safety studies, and contextualization of observed adverse events to inform a robust characterization of the benefit-risk profile of Moderna products throughout the lifecycle.

The successful candidate must be driven, curious, and collaborative with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines and therapeutics.  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:

• Provide epidemiologic input to questions related to product safety from multiple sources across the product lifecycle

• Design and execute observational studies concerning burden of disease for safety topics, safety surveillance in both spontaneous and population-based data sources, pregnancy safety, and prospective cohort event monitoring across diverse geographies.

• Lead efforts to identify fit-for-purpose data to meet real-world evidence generation needs suitable for submission to international health authorities.

• Set the scientific direction of studies and develop protocols, data analysis plans, study reports and peer-reviewed publications.

• Present findings to diverse audience of internal and external stakeholders.

• Lead or contribute to safety epidemiology content for regulatory plans/documents and aggregate reports. Interact with regulatory agencies and other external authorities as needed.

• Contribute to epidemiologic knowledge 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 evidence generation.

• 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 experience will be considered.  Preference given to candidates with previous experience in use of real-world data to conduct post-authorization safety studies meeting international regulatory commitments.

• 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.

  • Lead cross-functional teams and work streams.

• Experience in pharmacoepidemiology or prior research working with large electronic healthcare databases (e.g., EHR, administrative/claims data).

• Able to conduct epidemiologic analyses in SAS.

• 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 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;