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Sr. Director, Head of Regulatory Strategic Transformation

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Nov 15, 2023

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role:

The Head of Regulatory Strategic Transformation at Moderna is responsible to leverage 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 Modernas product pipeline.

The successful Head of Strategic Transformation will have extensive experience across multiple phases of drug development, proficiency with Digital Solutions, experience in Project and Change 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 Modernas headquarters in Cambridge, MA or travel to Cambridge on a regular basis (at least once per month).

Heres What Youll Do:

The Head of Strategic Transformation will be involved in leading of the portfolio and programs by:

  • Leveraging technology, processes, and resources to drive the efficiency and effectiveness of the Regulatory Science function

  • 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 the individuals in the Strategic Transformation function.

Heres What Youll 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 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 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, 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.

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

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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