Nuvalent, Inc.

Senior Director, Drug Metabolism and Pharmacokinetics

Nuvalent, Inc.

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $270,000 - $295,000 per year

Job Level

Senior

About the role

  • Provide scientific leadership for all DMPK activities across discovery, preclinical, and development-stage programs.
  • Develop and execute DMPK strategies, including ADME, bioanalysis, PK/PD modeling, and in vitro/in vivo metabolism studies.
  • Serve as the primary DMPK representative on program teams, influencing strategy, timelines, and go/no-go decision‑making.
  • Evaluate DMPK liabilities and optimization strategies for new chemical entities.
  • Serve as the DMPK lead on cross‑functional program teams (preclinical, clinical, regulatory, CMC, translational medicine).
  • Oversee design, outsourcing, and interpretation of ADME, PK, TK, and metabolism studies conducted under GLP and non-GLP conditions.
  • Lead bioanalytical method development and validation to support preclinical and clinical studies.
  • Ensure integration of PK/PD modeling and simulation to inform dose selection and clinical study design.
  • Build and manage relationships with CROs and external partners, ensuring quality, compliance, and scientific rigor.
  • Author and review DMPK sections of regulatory submissions (IND/CTA, IB, briefing packages, NDAs/MAAs).
  • Represent the company in regulatory agency interactions (FDA, EMA, etc.) as the DMPK subject matter expert.
  • Ensure compliance with all relevant regulatory guidelines, including GLP and ICH.
  • Lead DMPK strategy for Nuvalent’s pipeline ensuring data quality that supports INDs, NDAs, and global regulatory interactions.

Requirements

  • 12+ years of industry experience in DMPK, including leadership responsibility.
  • D. in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Chemistry, or related discipline; postdoctoral training preferred.
  • Proven track record supporting programs from discovery through clinical development; experience with IND and NDA/MAA submissions strongly preferred.
  • Demonstrated experience supporting small‑molecule oncology therapeutics, ideally kinase inhibitors or targeted therapies.
  • Hands‑on expertise with ADME assays and mechanistic metabolism studies and PK/PD modeling and simulation, proficient in Phoenix WinNonlin, preferred: experience with GastroPlus modeling.
  • Experience contributing to late‑stage development and NDA filings, preferably in oncology.
  • Prior experience supporting products approaching commercial launch.
  • Experience with vendor/CRO oversight and budget management.
  • Experience working in a small/mid-size biotech environment preferred (rapid decision-making, cross-functional collaboration, matrix leadership).
Benefits
  • medical, dental, and vision insurance
  • 401(k) retirement savings plan
  • generous paid time off (including a summer and winter company shutdown)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
DMPKADMEbioanalysisPK/PD modelingin vitro metabolism studiesin vivo metabolism studiesbioanalytical method developmentvalidationmechanistic metabolism studiesGastroPlus modeling
Soft Skills
scientific leadershiprelationship managementcross-functional collaborationinfluencing strategydecision-makingbudget managementcompliance assurancecommunicationteam leadershipproblem-solving
Certifications
Ph.D. in Pharmaceutical SciencesPh.D. in PharmacokineticsPh.D. in BiochemistryPh.D. in Chemistry