Senior Director, Clinical Pharmacology
Nuvalent, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $270,000 - $295,000 per year
Job Level
About the role
- 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.
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).
- Prior work with kinase inhibitors, and oncology therapies strongly preferred.
- Familiarity with late‑phase trial design and commercial launch preparation.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
- comprehensive benefit package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacokineticspopulation PK modelingPK/PD modelingexposure–response analysesdose selectiondose modificationregulatory submissionsoncology drug developmentkinase inhibitors
Soft Skills
leadershipmentoringcollaborationstrategic planningcommunication
Certifications
D.Pharm.D.M.D.