Director, Rare Disease Epidemiology & Clinical Outcome Assessments

The Role:

Moderna is seeking a Director of Epidemiology & Patient-Centered Outcomes Assessment (Epi, & PCOA) to support the strategy, design and implementation of evidence generation activities of Moderna’s Rare Disease mRNA technologies within its Therapeutics portfolio at the global level. The candidate has responsibility, under the supervision of the Epi Director, who is the program lead for various Rare Disease to lead one of these indications.  This includes the design, development, conduct, analysis, reporting and publication of pharmacoepidemiologic research studies, PCOA measurement and development strategy (where warranted), plan and execute the early reimbursement/HEOR activities and provide epidemiologic and methodologic input towards the clinical development needs of mRNA technologies.

Specifically, the candidate will support and/or lead as appropriate, activities focusing on generating observational evidence to support mRNA technologies associated with Inborn Errors of Metabolism. The role will report to Director, Epidemiology Lead. 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 very high unmet medical need. 

The candidate must have excellent oral and written communication skills, innovative approaches, a willingness to learn new concepts and a collaborative mindset. As this is a global role, the candidate may be called upon to work across different time zones at times. The candidate will be charged with understanding the observational data needs and opportunities to enhance drug development with the mRNA platform, and build expertise as needed within the Rare Disease portfolio.

Here’s What You’ll Do:

Epidemiology:

• Under the guidance and strategic leadership of the Senior Epi/ PCOA lead, accountable for the development and execution of the overall Epi/PCOA strategy for Propionic Acidemia (PA) and other future indications as determined by the needs of the portfolio.

• 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/real world evidence plans, as needed

• Responsible to support the strategy, vision and execution of high-quality pharmacoepidemiologic data outputs, for PA including:

  • 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, literature reviews, 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 input in terms of observational data 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 

• With guidance and direction from Indication Epi Lead, serve as a cross functional partner for HTA advice & building of economic models at global level

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

• Preferred: Analytical skills and technical knowledge of registries/real world data studies; general understanding of global (US, EU) 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 resear