Senior Director, US Regulatory Policy and Regulatory Intelligence

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 You’ll 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 Moderna’s 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 Moderna’s industry position.

Here’s What You’ll 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 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 resear