Full-Time

Director – Epidemiology

Oncology

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA

Expected to be in office 70% of the time with flexibility to work from home up to 30%.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Google Cloud Platform
Requirements
  • PhD in Epidemiology or Pharmacoepidemiology strongly preferred and MPH/MS in Epidemiology in combination with other advanced degrees or experience considered.
  • Minimum 5 years’ experience in an industry setting, preferably in a related therapeutic area.
  • Proven track record in planning and execution of Epidemiology Plans to enhance value and accelerate development.
  • Deliver high-quality results within established timelines.
  • Lead cross-functional teams and work streams.
  • Innovation in trial design including leveraging synthetic controls and real-world data.
  • Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with regulatory authorities.
  • 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 team members across functions.
  • Exceptional written and oral communication skills to meet the needs of varied audiences.
Responsibilities
  • Accountable for the leadership, development, and execution of the overall Epi strategy for PCV & other Oncology modalities.
  • Provide epidemiological input to the product development, including clinical, safety, and economic outcomes and contribute to the integrated evidence plans for Oncology Programs.
  • Design and execute pre-launch, launch and post-marketing epidemiology plans.
  • Responsible to define the strategy, vision and execution of high-quality pharmacoepidemiologic data outputs for PCV Oncology modalities including: Set the scientific direction and develop protocols, data analysis plans, study reports and peer-reviewed publications.
  • Conduct Literature reviews, gap analyses & mathematical modeling, for safety, effectiveness, and impact studies.
  • Conduct studies from conceptualization, through publication of descriptive, cohort, cross-sectional, or observational studies or registries.
  • Design and input into clinical trial or external control studies to ensure value-drivers for provider/patient/payer evidence needs from launch through LOE are included.
  • Provide epidemiologic analysis or literature-based indirect treatment comparisons to fill knowledge gaps and inform (data contextualization, event rates, population descriptors, etc).
  • Serve as a critical partner and reviewer with external development partners and collaborators in Oncology.
  • Active team member providing strategic epidemiologic input and strategy to the development team in collaboration with cross-functional partners on the clinical development plan, regulatory interactions, clinical study design, efficacy and safety endpoints.
  • Support mRNA development by contributing strategically to the assessment of need for use of observational data, evaluation of data sources, design and conduct of observational studies for RD needs and/or developing mRNA technologies.
  • Serve as a lead and cross functional partner for early HTA advice.
  • Provide epidemiologic support to other development Moderna therapeutics programs as needed.
  • Provide innovative solutions on RWE for use as a synthetic/historical or concurrent control, including expertise on methodological considerations to account for confounding, missing variable, temporal or other biases and/or methodological challenges which may need to be thought through, including alternative methodological approaches (Bayesian, Adaptive, etc).
  • Develop research methodologies and implement innovative analytical approaches for Epi & RWE.
  • Develop protocols for RWD analysis of claims data or electronic health records and execution of RWE studies to identify and fill gaps and ensure delivery of robust evidence alongside clinical development and value-based RWE needs.
  • Proactively prepare for mRNA use and exposure by establishing epidemiological and RWE on the key disease, population, demographic and clinical variables.
  • Lead RWE publications for congresses and peer-reviewed journals.
  • Develop and maintain strong, collaborative relationships with the broader Moderna organization and with external experts.

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 chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and create effective treatments for a range of diseases.

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

  • mRNA technology is expanding into personalized cancer vaccines, revolutionizing treatment.
  • Recent advancements in lipid nanoparticle delivery enhance mRNA vaccine efficacy.
  • Global mRNA vaccine market projected to grow significantly, boosting Moderna's prospects.

What critics are saying

  • Potential exclusion from Nasdaq 100 could impact investor perception and liquidity.
  • Bypassing safety steps in Australia may raise regulatory scrutiny.
  • Geopolitical tensions in China pose operational and financial risks for Moderna.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company has developed one of the earliest and most effective COVID-19 vaccines.
  • Moderna's mRNA platform enables rapid development of vaccines for various diseases.

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