What are the responsibilities and job description for the Director of Clinical Pharmacology position at BioPhase?
- California Candidates highly preferred - must be willing to travel to San Diego monthly.
Director, Clinical Pharmacology
The Director of Clinical Pharmacology will lead clinical pharmacology and pharmacometric strategies for small molecule programs, supporting development from pre-IND through late-stage trials. This role will design and oversee studies evaluating pharmacokinetics, pharmacodynamics, dose optimization, and drug interaction potential, while collaborating closely with Clinical, Research, DMPK, Biometrics, Regulatory, and CMC teams.
Key Responsibilities
- Develop and implement clinical pharmacology and pharmacometric strategies, including dose selection, optimization, and risk mitigation.
- Design, analyze, interpret, and report clinical pharmacology studies; contribute to protocols, study reports, and regulatory filings (IND, NDA, IB, etc.).
- Provide scientific input to cross-functional teams and regulatory agencies, supporting clinical development decisions.
- Manage external vendors and consultants to ensure quality and compliance.
- Present PK/PD and modeling results to project teams, senior management, and regulatory bodies.
Requirements
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or related field with 7 years of industry or postdoctoral experience.
- Proven experience with regulatory submissions (NDA/BLA/MAA) and interactions.
- Excellent communication skills and ability to translate complex pharmacology data for diverse audiences.
Salary : $200,000 - $250,000