Full-Time

Director – Epidemiology

Oncology

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

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 molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

15%

2 year growth

53%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.

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