Senior Director, US Regulatory Policy and Regulatory Intelligence

1 week ago

Bethesda, United States Moderna, Inc. Full time

The Role:

The Senior Director of US Regulatory Policy and Regulatory Intelligence is a pivotal leadership role at Moderna, requiring extensive expertise in regulatory frameworks and a nuanced understanding of policy development both in the U.S. and internationally. This seasoned leader will oversee a sophisticated function that includes comprehensive global policy intelligence, proactive analysis of regulatory environments, and strategic development of advanced policy positions. This role is critical in leading advocacy strategies to significantly shape policies impacting the biotechnology sector, leveraging strong relationships with global health authorities such as the US Food and Drug Administration (FDA).

Here's What Youll Do:

Strategic Leadership: Lead the development and execution of a comprehensive regulatory policy plan for the U.S., designed to anticipate future business and regulatory landscapes. This includes co-designing with teams across Global Regulatory Sciences, Safety and Pharmacovigilance, Clinical Development, and Quality leadership.

Policy Advocacy: Spearhead high-level initiatives to propose and respond to legislation, regulations, guidelines, and policies. Plan and manage strategic interactions with trade associations and health authorities, solidifying Moderna's industry-leading stance.

Stakeholder Engagement: Serve as Moderna's chief representative on key policy issues, effectively shaping the regulatory environment through strategic alignment and proactive engagements with the FDA and other stakeholders.

Communication and Influence: Direct complex discussions with external policy bodies, delivering expert insights and strategic guidance to senior leadership, thereby integrating regulatory trends into broader corporate strategy.

Innovation and Impact: Expand Modernas regulatory influence through innovative partnerships, leadership in industry forums, and dynamic advocacy efforts. Define and measure success through clear impact metrics such as policy influence, operational efficiencies, and enhancement of Modernas industry position.

Heres What Youll Bring to the Table:

Educational Background: Advanced degree (Doctorate preferred) in science, healthcare, public health, health policy, or law.

Professional Experience: Minimum of 15 years of progressive experience in regulatory roles with significant leadership responsibilities, preferably involving direct interactions with the FDA or equivalent bodies.

Leadership Qualities: Demonstrated transformative leadership abilities with a proven track record in strategic decision-making and influencing regulatory environments. Known for inspiring and motivating high-performing teams.

Communication Skills: Exceptional ability to articulate complex regulatory strategies and influence a diverse array of stakeholders, including technical experts, senior government officials, and industry leaders.

Innovative Thinking: Renowned for strategic acumen and innovative problem-solving, anticipating future trends and crafting preemptive strategies.

Collaboration: Extensive experience in leading diverse, cross-functional teams and managing stakeholder relationships across different cultural and geographical boundaries.

Travel: Willingness and ability to travel internationally to represent Moderna at high-level engagements.

Language: Fluent in English with exemplary persuasive writing and speaking skills.

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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-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 peopleare 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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

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. Were 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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