Full-Time

Director – Epidemiology

Infectious Diseases, Norovirus

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA + 1 more

More locations: Bethesda, MD, USA

70/30 work model requiring 70% in-office presence.

Category
Public Health
Biology & Biotech
Required Skills
Data Analysis
Google Cloud Platform
Requirements
  • PhD in Epidemiology or related field is preferred, equivalent relevant experience will be considered.
  • Minimum 3 years’ experience in an industry setting, preferably in vaccines or a related therapeutic area.
  • Proficiency in epidemiological study design, data analysis, and use of large electronic healthcare databases (e.g., EHR, administrative/claims data).
  • 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.
Responsibilities
  • 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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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