The Role

The Medical Affairs Global Real World Evidence organization leads real world evidence generation for medical outcomes and implementation science associated with the use of specific mRNA products across all therapeutic areas, diseases prevented or treated, and the mRNA platform generally. The evidence generated must be meaningful, valid, and timely to inform patients, healthcare providers, and healthcare/public health/regulatory decision makers seeking optimal health outcomes.

The Senior Director, Real World Data & Insights, RWE Platform, is the key internal authority for causal inference for RWE including but not limited to point of care trials or prospective studies enabled with digital health technologies, observational clinical studies using linked licensed data and analytics, and engagements with partner networks globally. In addition, the Senior Director, Real World Data & Insights is the key interface from the Chief Medical Officer organization for joint analyses with Data Science and Artificial Intelligence within the Chief Information Officer/Digital organization.

The Senior Director, Real World Data & Insights collaborates with the Senior Director, Clinical Epidemiology and Informatics to assess data quality for new data sources, plan for prospective data capture in point of care RWE studies, and design queries and dashboards as appropriate for insights generation using RWE platform tools. The Senior Director, Real World Data & Insights will also drive RWE policy and methods advancement through cross-industry and public-private consortia.

Here’s What You’ll Do

• Shape study strategy through specification of causal questions, causal models, and sensitivity analyses

• Address and align analytic plans that include machine learning (e.g., Targeted Minimum Loss-Based Estimation and Super Learning) in RWE studies

• Incorporate best practices exemplified by but not limited to target trial emulation, Patient Centered Outcomes Research Institute Methodology Standards, the RECORD statement, the STaRT-RWE template, ICH E9(R1), and FDA RWE guidance

• Serve as RWD & Insights lead for internally conducted real world database studies, including overseeing/writing analytical sections of research protocols and statistical analysis plans, managing delivery of analyses, and reporting results

• Lead methods assessments of high impact external studies relevant to the mRNA platform and conduct expedited replication and/or sensitivity analyses using licensed data sources

• As data needs expand globally and beyond traditional biopharma vendor relationships, conduct Real World Data quality assessment to inform acquisition and ongoing use jointly with the Senior Director, Clinical Epidemiology and Informatics

• Assess and recommend improvements to analytic tools acquired by the RWE Platform and the Chief Information Officer/Digital organization

• Ensure insights delivery pivots to address emerging topics/trends/evidence needs from key external stakeholders

• Lead demonstration projects and engagements with cross-industry and public-private consortia advancing RWE policy and methods

• Implement new visualization and communication approaches

• Communicate scientific findings internally and externally

Here’s What You’ll Need (Minimum Qualifications)

• Advanced degree in epidemiology, health economics, statistics, pharmaceutical sciences, or related discipline (MS, MPH, PharmD, PhD)

• 10+ years of job relevant experience in the Biopharma Industry, Health Data Industry, Service Provider, Academic, Clinical, or Regulatory/Payer experience connected to the medical product development lifecycle

• Prior application of guidance, standards and best practices related to epidemiologic design, statistics/causal inference, and evidence-based medicine

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Prior experience with SAS, R, and analytic platforms such as Aetion and TriNetX preferred

• Interest in deeply engaging with the Data Science and Artificial Intelligence team and others within the Chief Information Officer/Digital organization to obtain maximum impact from Amazon Web Services tools

• Strong oral and written communication skills including data visualization to influence and effectively engage internal and external audiences

• Capacity to maintain attention to detail and prioritize a growing and dynamically changing portfolio of activities in a fast paced environment

• Ability to inspire respect and trust from others, negotiate, collaborate, incorporate awareness of cultural differences, and lead matrixed internal and external teams

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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, the infrastructure 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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