Scientific Director, DMPK
Company: Moderna Therapeutics Inc.
Location: Cambridge
Posted on: November 6, 2024
Job Description:
The RoleAt Moderna, our mission is to deliver the greatest
possible impact to people through mRNA medicines. We foster a
dynamic, diverse, and innovative workplace where every individual's
contribution is vital.In this role, you will serve as a Drug
Metabolism and Pharmacokinetic (DMPK) subject matter expert and
functional line representative on drug development program teams to
enable drug candidates from discovery through marketing. You will
apply deep knowledge and technical expertise in absorption,
distribution, metabolism, and excretion (ADME), pharmacokinetics
(PK), and pharmacodynamics (PD) to drive development program
strategy and define new scientific directions of the department
with leadership. Strong communication skills and comfort working in
a dynamic, fast-paced, cross-functional team environment are
required.Here's What You'll Do
- In conjunction with development program teams and a
cross-functional and integrated nonclinical sciences team, develop
ADME/PK/PD and drug-drug interaction (DDI) risk assessment
strategies and provide expert support to discovery and development
projects.
- Design, execute, and critically analyze nonclinical in vitro
and/or in vivo studies conducted in multiple species via
collaborative partnerships with study monitors and other partner
line program representatives (e.g., pharmacology, toxicology,
bioanalytical, operations, etc.).
- Collaborate closely with pharmacometrics PK/PD modelers to
define the PK/PD studies and data needed to establish quantitative
PK/PD correlations and translational strategy, and support
first-in-human (FIH) dose projections for development
programs.
- Provide strategic advice to project teams and senior management
including evaluation of conclusions and potential impact of study
results on program and clinical/regulatory strategy.
- Review, edit, and/or author regulatory submissions and health
authority interaction documents (e.g., briefing documents,
regulatory query responses) for assigned programs and integrate
results with toxicology and pharmacology.
- Regularly operate as a leader by mentoring and having direct
and/or matrix management responsibilities for other DMPK program
representatives by providing scientific guidance and input and by
leading by example.
- Manage the preparation and presentation of ADME/PK/PD/DDI data
for project teams, portfolio management, internal/external partners
and/or scientific groups.
- Maintain extensive scientific awareness and presence internally
and externally, leading initiatives to publish manuscripts and
posters, present at scientific conferences and other scientific
forums, engage with consultants and advisors in the field, as well
as the scientific community at large.
- Additional duties within nonclinical function may be assigned
from time to time.Here's What You'll Need (Minimum
Qualifications)
- PhD & 10 years of scientific experience OR Master's degree & 15
years of scientific experience OR Bachelor's degree & 20 years of
scientific experience in preclinical drug metabolism and
pharmacokinetics (DMPK) and drug development in the
pharmaceutical/biotechnology sector.
- Experience serving in the capacity of a DMPK representative on
drug discovery and development programs in the
pharmaceutical/biotechnology industry and corresponding experience
in designing and executing nonclinical ADME/PK/PD/DDI strategies
and studies to support clinical development.
- Experience in mentoring, coaching, or managing others on
developing ADME/PK/PD/DDI strategies.
- Experience in applying DMPK in diverse modalities.
- Direct experience in writing and reviewing nonclinical sections
of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs,
briefing documents, regulatory query responses).
- Familiarity with regulatory guidelines for the conduct of
ADME/PK/PD/DDI studies to support regulatory filings.
- Experience working with Contract Research Organizations.Here's
What You'll Bring to the Table (Preferred Qualifications)
- Outstanding written and verbal communication skills and the
ability to develop and deliver clear and concise presentations for
both internal and external stakeholders.
- Attention to detail and quality, and ability to deliver work on
time.
- Demonstrated ability to work collaboratively and successfully
in a fast-paced and dynamic work environment, with the agility to
quickly pivot in the face of new data and/or strategic
directions.
- Experience in significantly impacting departmental and
organizational initiatives that have shaped research
strategies.
- Demonstrated expertise and depth of knowledge within a
scientific area; well-developed knowledge of other scientific
areas.
- A desire to make an impact as 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 ModernaSince 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.If you want to make a
difference and join a team that is changing the future of medicine,
we invite you to visit 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 . (EEO/AAP Employer)
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Keywords: Moderna Therapeutics Inc., Chicopee , Scientific Director, DMPK, Executive , Cambridge, Massachusetts
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