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Sr. Director, Head of Regulatory Strategic Transformation

Company: Moderna Therapeutics Inc.
Location: Cambridge
Posted on: May 28, 2023

Job Description:

The Role:The Head of Regulatory Strategic Transformation at Moderna is responsible to integrate technology, processes, and resources and drive initiatives leading to drive the expansion and scaling up of the Global Regulatory Science (GRS) capabilities and optimize the efficiency, quality, and performance of the GRS Function. The GRS transformation is critical to support the rapidly expanding Moderna's product pipeline.In addition to co-leading strategic initiatives including Digital Initiatives, this role oversees the Regulatory Project Management function to enable Global Regulatory Sub-Teams strategic initiatives and objectives related to the development of novel mRNA medicines.The successful Head of Strategic Transformation will have extensive experience across multiple phases of drug development, proficiency with Digital Solutions, experience in Project Management, and superior communication and collaboration skills to generate holistic processes aiming for regulatory operational excellence.This person is a highly resourceful individual with strong in-direct leadership, self-motivation, and strong program leadership skills. They anticipate needs and demands and work to provide logical, innovative and creative solutions and related change management strategies without being given precise direction. This person will sit at Moderna's headquarters in Cambridge, MA or travel to Cambridge on a regular basis (at least once per month).Here's What You'll Do:The Head of Strategic Transformation will be involved in leading of the portfolio and programs by:

  • Integrating technology, processes, and resources to drive the efficiency and effectiveness of the Regulatory Science function
  • Overseeing regulatory project management (RAPM) function to support the strategic regulatory objectives and initiatives
  • Leading the design, development and scaling of capabilities, tools and processes.
  • Partnering with functional leadership and program leader(s) to shape portfolio and program strategy and drive execution plans
  • Collaborating with Digital and Clinical Operations to develop a roadmap and lead regulatory/digital solutions.
  • Leading initiatives to assess gaps and develop, improve and implement processes as well as corresponding meaningful metrics and KPIs to track performance and progress against regulatory priorities
  • Developing regulatory communication tools through partnerships with RegOps, Reg-Strategy, Reg-CMC, Portfolio Management, and Digital to effectively identify, plan for and manage timeline completion for development program regulatory milestones
  • Coordinating team efforts to develop impactful presentations to summarize complex topics into critical points to facilitate strategic planning and decision-making
  • Preparing regulatory program status update and governance presentations to the EC, to the DLT, and/or to the CMC LT.
  • Developing and tracking regulatory activities against portfolio & program timelines and budget.
  • Building, mentoring and training program management team to support programsHere's What You'll Bring to the Table:
    • Bachelors, advanced degree highly preferred; experience in drug development in a biotechnology or pharmaceutical setting
    • Minimum 12+ years of experience in strategy, global regulatory affairs, project management, Digital development, and change management.
    • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
    • Strong communication skills and willingness to lead as a change agent
    • Demonstrated experience building, running, and managing programs, projects, and processes
    • Demonstrated ability to independently move projects forward by gaining support from others and to work collaboratively with cross-functional groups to set objectives, drive progress, and produce meaningful results
    • Excellent organization and planning skillsModerna 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 ModernaIn 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 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 (EEO/AAP Employer)#LI-TR1-

Keywords: Moderna Therapeutics Inc., Cambridge , Sr. Director, Head of Regulatory Strategic Transformation, Executive , Cambridge, Massachusetts

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