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.
Requirements
- Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post-marketing studies
- Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations
- Represent clinical pharmacology in interactions with FDA and other global regulators
- Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs
- Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety
- Guide quantitative pharmacology approaches supporting optimal dosing in patients
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement savings plan
- Generous paid time off
- Summer and winter company shutdown