Director, Rare Disease Epidemiology & Clinical Outcome Assessments, Therapeutic

The Role:

Moderna is seeking a Director of Epidemiology & Patient-Centered Outcomes Assessment (Epi & PCOA) to lead the strategy, design and implementation of evidence generation activities of Modernas Rare Disease mRNA technologies within its Therapeutics portfolio. The Director, Epi & PCOA, has responsibility for the design, development, conduct, analysis, reporting and publication of pharmacoepidemiologic research studies, PCOA measurement and development strategy (where warranted), and to provide guidance and epidemiologic and methodologic input towards the clinical development needs of mRNA technologies.

Specifically, the director will lead Epi & PCOA activities for mRNA technologies focusing on rare disease (RD) of Inborn Errors of Metabolism- focusing on Propionic Acidemia (PA) and other future RD indications. The role will report to the Senior Director, Epidemiology Lead, Therapeutics. 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 build expertise as needed within Epidemiology for Rare Diseases within Therapeutics.

Heres What Youll Do:

Epidemiology:

Accountable for the leadership, development, and execution of the overall Epi strategy for PA.

• Provide Epi input to the product development, including clinical, safety, and economic outcomes and contribute to the integrated evidence plans for PA.

• 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 PA 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)

• Active leader and 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 strategic contribution 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 functionally partner for HTA advice & building of economic models.

• Provide epidemiologic support to other RD Moderna therapeutics programs as needed.

• Preferred: General understanding of global payer and market access evidentiary needs and reimbursement environment and the processes associated with reimbursement and formulary access to enable input into CDP and other evidence generation needs

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.

Patient-Centered Outcomes Assessment (PCOA):

• Support PCOA, including the development, validation (or adaptation) and creation of Clinical Outcome Assessments (COA) and psychometric measurement strategy

• Select & incorporate COA endpoints and implement strategy and input into COA measurement section protocols and CDP and to develop briefing documents in support of and attend regulatory interactions as the Moderna subject matter expert

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 considered. Preference given to candidates with previous experience in drug development.

• 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.

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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