VP, Regulatory Affairs, Oncology & INT at ModernaTX, Inc. in Cambridge, Massachusetts

Job Description:

The Role:



As VP of Regulatory Affairs for Oncology and INT, you will lead and develop the regulatory strategy for Moderna's oncology and individualized neoantigen therapies programs. You will work collaboratively to articulate clear and compelling regulatory strategies, highlighting risks and opportunities, and leveraging the mRNA platform technology. Your leadership will be pivotal in navigating the complex interplay between the FDA, EMA, and other international health agencies, ensuring successful registration and commercialization of oncology and INT products.



Here's What You'll Do:

• Strategic Leadership: Design and execute the strategic vision for regulatory affairs in Oncology and INT, ensuring alignment with Moderna's global business objectives.
  
  


• Regulatory Submissions: Oversee the preparation, submission, and approval processes for regulatory filings, including IND amendments and supplements.
  
  


• Regulatory Compliance: Monitor regulatory developments and provide guidance to project teams regarding the implementation of regulatory strategies.
  
  


• Agency Interaction: Establish and maintain relationships with regulatory agencies, respond to requests for additional data, and negotiate with regulatory authorities.
  
  


• Policy Development: Develop and implement regulatory policies and practices in compliance with federal and international guidelines.
  
  


• Team Leadership: Manage and develop a high-performing regulatory team, ensuring the team is equipped to meet regulatory milestones.
  
  


• Cross-functional Collaboration: Partner with internal teams and external partners to manage submissions and ensure regulatory compliance.
  
  


• Global Regulatory Lead: Serve as the global regulatory lead, accountable for all regulatory aspects of assigned projects, including the development and implementation of global regulatory development plans.
  
  


• Communication: Effectively communicate regulatory strategies, risks, and plans to the GRS, project development teams, and senior management.
  
  


• Resource Management: Ensure appropriate levels of resources and manage the regulatory budget.
  
  


• Continuous Improvement: Identify and implement process improvements to enhance regulatory practices.
  
  

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

• BA/BS degree in a scientific/engineering discipline required; Masters or PhD preferred.
  
  


• Minimum of 15 years of regulatory experience in biotech, pharma, or clinical research organizations, with 12+ years in regulatory strategy.
  
  


• In-depth knowledge of relevant FDA, EU, ICH guidelines, and regulations, particularly for oncology and individualized therapies.
  
  


• Proven experience with regulatory filings and negotiations with FDA and international health authorities.
  
  


• Excellent communication skills and the ability to convey complex regulatory issues clearly.
  
  


• Strong leadership and team management skills.
  
  


• Ability to work independently and manage multiple projects in a fast-paced environment.
  
  


• A desire to be 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.


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


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