Sr. Director, Benefit Risk, Global Safety Epidemiology
The Senior Director, Benefit Risk, Global Safety Epidemiology leads structured benefit-risk assessments and patient preference studies across all therapeutic areas including infectious disease/vaccines, rare disease, advanced therapeutics, and oncology. Structured patient-focused benefit-risk deliverables should be recognized as meaningful, valid, and timely to inform patients, healthcare providers, and healthcare/public health/regulatory decision makers seeking optimal health outcomes.
The role plans and leads the portfolio of structured benefit risk assessments, critically assesses external evidence inputs, generates evidence utilizing global safety epidemiology resources to support these assessments, ensures alignment with best practices, and authoritatively represents the results to internal and external stakeholders. Additionally, the Senior Director actively identifies variations in methodology and data sources utilized by different regulatory and public health agencies, HTAs/NITAGs, medical/professional societies to improve and customize frameworks.
The Senior Director, Benefit Risk integrates with other global safety epidemiology studies and activities to leverage data resources and emerging evidence. The role requires collaboration with safety leads, country-level pharmacovigilance and medical affairs staff, franchise and regional integrated evidence teams, and peer leaders in the Global Medical RWE Platform, Therapeutic Areas, Regulatory, Market Access and Health Economics and Outcomes Research, and Data Science and Artificial Intelligence.
Here’s What You’ll Do
Drive patient focused benefit risk deliverable development from the elicitation of key inputs through analysis and conclusions for packaging in regulatory submissions (pre and post marketing), health authority advisory committee meetings, and internal development and safety governance
Review and prepare responses for external benefit risk assessments intersecting with the mRNA platform or the diseases treated/prevented and existing treatment options
Actively scan new policy and methodological approaches to descriptive and quantitative benefit risk methodology and patient preference elicitation through the literature and interaction with regulatory and public health authorities
Optimize benefit risk frameworks taking clinical, mRNA therapeutic area, population, and local practice context into account
Contribute to publication plans and submissions to clinical and scientific congresses
Drive associated business processes both internally and with external collaborators and vendors to deliver results
Develop new data sources as well as visualization and communication approaches
Ensure the Global Safety Epidemiology Benefit Risk portfolio pivots to address emerging topics/trends/evidence needs from key external stakeholders
Lead demonstration projects and engagements with academic, cross-industry, and public-private consortia advancing Benefit Risk policy and methods
Here’s What You’ll Need (Minimum Qualifications)
Advanced degree in epidemiology, health economics, statistics, pharmaceutical sciences, or related discipline (MS, MPH, PharmD, PhD)
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)
Safety RWE/pharmacoepidemiology experience within industry or from service provider organizations (contract, academic, or healthcare data/analytics) across the product lifecycle preferred; Exceptional candidates with extensive operations research experience may be considered
Prior application of guidance, standards and best practices related to descriptive frameworks (e.g., FDA benefit-risk framework, PrOACT-URL and BRAT frameworks) and Quantitative frameworks (e.g., Multi-Criteria Decision Analysis)
Experience with analytical software such as SAS, R, or MATLAB
Familiarity with emerging patient preference and personalized benefit-risk assessment methods
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!
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 email@example.com. (EEO/AAP Employer)