NJ (Hybrid 3 days on site/possible remote)
Position Overview
The Director, Clinical Pharmacology will lead clinical pharmacology strategies to support the development of drug candidates across all phases. This role involves oversight of PK/PD study design, dose selection, regulatory documentation, and cross-functional collaboration, with a strong emphasis on early-phase development and pharmacometric analyses.
Key Responsibilities
- Lead the design, execution, and interpretation of PK/PD studies across all clinical phases.
- Serve as Clinical Pharmacology lead on project and study teams.
- Drive dose selection strategies for Phase 1–3 trials.
- Conduct or oversee PK/PD and population modeling analyses.
- Contribute to clinical protocol development, study reports, and regulatory filings (INDs, NDAs, IBs).
- Collaborate with preclinical, clinical, regulatory, and biostatistics teams.
- Participate in Phase 1 CRO selection and provide scientific oversight.
- Mentor junior team members and support due diligence activities.
Essential Qualifications
- Ph.D. or Pharm.D. in Pharmaceutical Sciences or related field.
- 7+ years of industry experience in clinical pharmacology, PK/PD, and pharmacometrics.
- Demonstrated leadership in clinical pharmacology programs; oncology experience preferred.
- Proficiency with pharmacometric tools such as NONMEM and R.
- Strong verbal and written communication skills.
- Ability to work independently and thrive in a cross-functional, matrixed environment.
