Director Of Clinical Pharmacology

Overview

• Lead clinical pharmacology strategies for CNS therapeutic programs, integrating PK/PD principles and quantitative modeling to optimize drug development.
• Serve as the primary clinical pharmacology representative on cross-functional development teams, ensuring scientific and operational excellence.
• Design and execute clinical pharmacology strategies, leveraging translational sciences and nonclinical ADME/DMPK data.
• Contribute to regulatory submissions, health authority interactions, and clinical pharmacology study design and execution.
• Promote model-informed drug discovery and development through external collaboration and scientific publications.
• Act independently within a matrixed clinical development organization, providing innovative and progressive input to project teams.
• Collaborate with multidisciplinary teams to ensure efficient drug development and optimal dose selection.
• Enhance clinical pharmacology practices through leadership and communication excellence.

Key Responsibilities & Duties

• Develop clinical program designs, trial protocols, analysis plans, and study reports for CNS therapeutic programs.
• Conduct pharmacokinetic analysis, exposure-response analysis, and simulation-based trial design for dose optimization.
• Lead clinical pharmacology components of regulatory submissions and participate in health authority interactions.
• Promote model-informed drug discovery through external collaborations, publications, and conference presentations.
• Write and review clinical pharmacology sections of regulatory documents and responses.
• Provide guidance and innovative thinking to multidisciplinary project teams.
• Oversee pharmacokinetic/pharmacodynamic modeling and bioanalytical analysis.
• Manage internal and external personnel for outsourced clinical pharmacology projects.

Job Requirements

• Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacometrics, or related field with 10+ years of clinical pharmacology experience.
• Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
• Proficiency in programming tools like NONMEN, Phoenix NLME, R, and WinNonlin.
• Experience with FDA regulatory guidance and direct interaction with FDA for IND and NDA submissions.
• Expertise in non-compartment and model-based PK/PD analyses and scientific writing.
• Demonstrated leadership, communication, and time-management skills in a matrixed team environment.
• Knowledge of CNS therapeutic programs and clinical pharmacology paradigms.
• Experience managing internal and external teams for outsourced projects.