Sr. Director, Global Regulatory Strategy- Oncology

The Role:

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory strategy for Oncology programs to be based in its Cambridge headquarters, Bethesda, MD or Princeton, NJ. This is a new role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA infectious disease vaccines as unprecedented new drug modality globally. The Sr. Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. Prior regulatory experience with Oncology development preferred.

Here's What Youll Do:

• Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments.

• Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.

• Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments.

• Monitors regulatory developments related to mRNA platform with focus on vaccine development and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes.

• Establishes and maintains excellent relationships with global health agencies.

• Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.

• Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.

• Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.

• Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.

• Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.

• Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.

• Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevanthealth authorities as appropriate

• Identify areas in need of improvement and lead the development and implementation of process improvements

• Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables

• Manages a team of Regulatory strategists that are responsible for the portfolio deliverables and act as Global Regulatory leads or delegates for specific programs

Heres What Youll Bring to the Table:

• BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.

• 12+ years of experience in the Pharmaceutical industry

• 8+ years of experience in Regulatory strategy, including specifically: Oncology Development

• Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs.

• Strong experience with CTD format and content regulatory filings

• Experience with developing and implementing competitive regulatory strategies

• Demonstrated track record in securing product approvals and maintaining a complex portfolio

• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance preferably from at least both US and EU

• Direct experience of leading regulatory authority meetings in different phases of drug development

• Regulatory knowledge across therapeutic areas including oncology is preferable.

• Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

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

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each programs critical regulatory milestones.

• Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.

• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs the Project Team and senior management, as relevant.

• May be responsible for line management and development of direct reports.

• Identify areas in need of improvement and lead the development and implementation of process improvements.

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

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

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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