Senior Director, Clinical Pharmacology
Nuvalent · Cambridge, Massachusetts, US
The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with...
Job description
The Company: 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. 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: Competencies: Qualifications: - 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 submissio...