Senior Director, Drug Metabolism and Pharmacokinetics (DMPK)

About the role

The Senior Director, DMPK will serve as the company's key expert overseeing DMPK strategy across the entire company, including late-stage discovery, development, NDA submission, and commercial readiness, as well as designing, implementing, and interpreting DMPK studies, ensuring high-quality data and regulatory-ready documentation to support IND, CTA, and NDA filings. As part of a growing biotech organization, the role requires a hands-on, collaborative leader who can build and guide a high-performing team while working cross-functionally to advance a dynamic portfolio. This is a pivotal leadership role in a fast‑growing biotech preparing for its first commercial launch.

Responsibilities

• 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).
• Study Design & Execution
• 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.
• Regulatory and Documentation
• 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.
• Competencies
• Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
• Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
• Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
• Able to work independently, take initiative, and adapt quickly to evolving priorities.
• Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
• Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
• Ability to effectively manage multiple projects with competing priorities.

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).
• Annual Salary Range
• $270,000 - $295,000 USD
• Additional Information:
• Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.
• Nuvale

Additional Information

The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

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