Director, Epidemiology, Oncology - Moderna, Inc.

The Role:

Moderna is seeking a Director of Epidemiology to lead the strategy, design and implementation of evidence generation activities of Modernas Oncology mRNA technologies within its Oncology portfolio. The Director of Epidemiology has responsibility for the design, development, conduct, analysis, reporting and publication of pharmacoepidemiologic research studies, and to provide guidance and epidemiologic and methodologic input towards the clinical development needs of mRNA technologies.

Specifically, the Director will lead epidemiology activities for mRNA technologies focusing on Individualize Neoantigen Therapies (INT) and other Oncology indications. The role will report to the Executive Director and Epidemiology Lead, Therapeutics & Oncology. The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to ground-breaking drug development with potential to transform multiple diseases with high unmet medical need.

The candidate must have excellent oral and written communication skills, innovative approaches, and a collaborative mindset. The candidate will be charged with understanding the Epidemiology needs and opportunities to enhance drug development with the mRNA platform and work closely with external collaborators and partners on towards development and commercialization.

Heres What Youll Do:

Epidemiology:

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.

Real World Data & Evidence (RWD/E):

• 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.

• Key knowledge of RWD sources

Heres What Youll Bring to the Table:

• PhD in Epidemiology or Pharmacoepidemiology strongly preferred and MPH/MS in Epidemiology in combination with other advanced degrees or experience considered. Preference given to candidates with previous experience in drug development and Oncology.

• 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.

• This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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