Director Of Clinical Pharmacology

Director of Clinical Pharmacology Overview

• The Director of Clinical Pharmacology leads strategic and operational initiatives in clinical pharmacology activities for CNS therapeutic development.
• This role integrates PK/PD principles, modeling, and translational sciences for dose optimization and trial design.
• Collaborates with cross-functional teams to ensure efficient drug development processes and regulatory compliance.
• Provides subject matter expertise in pharmacokinetics, pharmacodynamics, and bioanalytical analysis.
• Leads clinical pharmacology components of regulatory submissions and health authority interactions.
• Promotes model-informed drug discovery through external collaborations and scientific publications.
• Contributes to innovative strategies for CNS therapeutic development and clinical investigation paradigms.
• Offers leadership and guidance within a matrixed clinical development organization.

Director of Clinical Pharmacology Key Responsibilities & Duties

• Design and execute clinical pharmacology strategies integrating PK/PD principles and quantitative modeling.
• Develop trial protocols, analysis plans, study reports, and regulatory submissions.
• Conduct pharmacokinetic analysis, exposure-response analysis, and population clinical pharmacology modeling.
• Lead clinical pharmacology study design and execution for CNS therapeutic programs.
• Collaborate with cross-functional teams to ensure efficient drug development and regulatory compliance.
• Present strategies and defend outcomes to governance boards and regulatory agencies.
• Promote model-informed drug discovery through scientific publications and conference presentations.
• Provide leadership and guidance within a matrixed clinical development organization.

Director of Clinical Pharmacology Job Requirements

• Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field.
• Minimum of 10 years of clinical pharmacology experience within the pharmaceutical industry.
• Strong understanding of pharmacokinetics, pharmacodynamics, and bioanalytical analysis.
• Experience with regulatory submissions and interactions with health authorities.
• Proficiency in programming tools like NONMEN, Phoenix NLME, R, and WinNonlin.
• Excellent scientific writing and presentation skills with peer-reviewed publications.
• Demonstrated leadership and communication skills in a matrixed team environment.
• Knowledge of CNS therapeutic development and clinical investigation paradigms.