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 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. 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
leavesandaccommodations@modernatx.com. (EEO/AAP
Employer)#LI-TR1-
Keywords: Moderna Therapeutics Inc., Cambridge , Sr. Director, Head of Regulatory Strategic Transformation, Executive , Cambridge, Massachusetts
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