Senior Director, Drug Metabolism and Pharmacokinetics (DMPK)

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.

Qualifications

• 12+ years of industry experience in DMPK, including leadership responsibility.
• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Chemistry, or related field.