Senior Director, Clinical Pharmacology

The Role

The Senior Director, Clinical Pharmacology will lead Nuvalent’s clinical pharmacology strategy across all development programs, including late‑stage registrational efforts and emerging early‑phase assets. This leader will guide dose optimization, exposure–response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions.

Responsibilities

• Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post‑marketing studies, including designing and leading clinical pharmacology studies.
• Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations.
• Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDA submissions.
• Represent clinical pharmacology in interactions with FDA and other global regulators, supporting discussions related to dose justification, pediatric waivers, safety margins, and DDI strategies.
• Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs to ensure cohesive end‑to‑end development plans.
• Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety.
• Guide quantitative pharmacology approaches supporting optimal dosing in patients.
• Build and mentor a growing clinical pharmacology function as Nuvalent transitions from clinical‑stage to commercial‑
• Contribute to portfolio prioritization, scenario planning, and long‑range clinical development strategy.

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

• D., Pharm.D., or M.D. with specialization in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 12+ years of experience in clinical pharmacology within biopharma, including leadership in oncology or small‑molecule drug development.
• Proven track record supporting registrational‑stage programs and authoring components of regulatory submissions (INDs, NDAs/MAAs).
• Prior work with kinase inhibitors, and oncology therapies strongly preferred.
• Familiarity with late‑phase trial design and commercial launch preparation.