Director Of Clinical Pharmacology

Job DetailExperience Level DirectorDegree Type Master of Science (MS)Employment Full TimeWorking Type HybridJob Reference 0000020198Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical pharmacology initiatives for CNS therapeutic development. Collaborate with cross-functional teams in a dynamic, matrixed environment. Drive innovation through modeling and scientific contributions.Job DescriptionDirector of Clinical Pharmacology OverviewThe 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 & DutiesDesign 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 RequirementsPh.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.