MA [hybrid]
Position Overview
The Director will provide strategic and scientific leadership for clinical pharmacology activities across development programs, with a focus on CNS therapeutics. This role serves as the clinical pharmacology lead on cross-functional teams, driving dose selection, study design, and regulatory strategy through the integration of PK/PD modeling, translational science, and nonclinical data.
Key Responsibilities
- Lead clinical pharmacology strategy, including dose optimization and modeling approaches
- Oversee PK/PD analyses, exposure–response modeling, and simulation-based trial design
- Contribute to clinical protocols, study reports, and regulatory submissions (e.g., INDs, NDAs)
- Present modeling strategies and outcomes to internal stakeholders and regulatory agencies
- Collaborate across multidisciplinary teams to support development decisions
- Promote model-informed drug development through publications and external engagement
Essential Qualifications
- Ph.D. or Pharm.D. in a relevant field with 10+ years of industry experience in clinical pharmacology
- Strong expertise in PK/PD modeling, biopharmaceutics, and drug development
- Proficiency in tools such as NONMEM, R, Phoenix, or WinNonlin
- Experience with regulatory submissions and direct interaction with health authorities
- Background in CNS therapeutics and small-molecule development preferred
- Strong leadership, communication, and project management skills
