Director, Rare Disease Epidemiology & Clinical Outcome Assessments

Cambridge, MA, United States

The Role:

Moderna is seeking a Director of Epidemiology, Early HEOR & Patient-Centered Outcomes Assessment (Epi, & PCOA) to support the strategy, design and implementation of evidence generation activities activities targeted towards supporting the regulatory approval and reimbursement

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 (early and late stage) associated with Inborn Errors of Metabolism. The role will report to the 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 and gap analyses 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 Evidence & Early HEOR:

Identify evidence gaps and needs from regulatory and reimbursement perspectives, resolve these challenges and define evidence generation priorities to support payers and regulators

Leading early payer scientific advice with global stakeholders including strategic insights on PROs, economic models and trial design

Defining and delivering the RWE and early HEOR strategy to support specified assets, and leading the integrated evidence teams to execute the activities needed for advancing assets through to launch

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

Here’s What You’ll Bring to the Table:

PhD in Epidemiology, Pharmacoepidemiology or Health Economics 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 5-7 years’ experience in an industry setting, preferably in a related therapeutic area and at least 8-10 years experience in consultancy supporting RWE/HEOR type activities

Proven track record in:

Planning and execution of Epidemiology/RWE and HEOR Plans to enhance value and accelerate development

Deliver high-quality results within established timelines

Lead cross-functional teams and work streams

Ability to interact with local and or regional stakeholders

Innovation in trial design including leveraging synthetic controls and real-world data

Ability to thrive and multi-task in a fast-paced environment is ESSENTIAL

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

• D iscretionary 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 people are 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.

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. We’re 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected] . (EEO/AAP Employer)

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