Scientific Director, Dmpk

The Role

At 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 individuals 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.

Heres What Youll 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., toxicology, bioanalytical, operations, etc.).

• Collaborate closely with pharmacometrics PK/PD modelers to define the PK/PD studies and data needed to establish PK/PD correlations 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 may be assigned from time to time.

Heres What Youll Need (Minimum Qualifications)

• PhD & 10 years of scientific experience OR Masters degree & 15 years of scientific experience OR Bachelors degree & 20 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector.

• Experience serving in the capacity of a DMPK representative on drug 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.

• 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.

Heres What Youll 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 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.

• 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 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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