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 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 quic