Senior Director, Clinical Pharmacology
About The Position
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 early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Reporting to the Chief Scientific Officer, 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.
Requirements
- 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).
Nice To Haves
- Prior work with kinase inhibitors, and oncology therapies strongly preferred.
- Familiarity with late‑phase trial design and commercial launch preparation.
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.
Benefits
- Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
