Director Clinical Pharmacology And Pharmacometrics

Overview

• Lead clinical pharmacology and pharmacometrics strategies to advance drug candidates through development stages.
• Collaborate with cross-functional teams to ensure project objectives are met efficiently.
• Provide expertise in pharmacokinetics, pharmacodynamics, and quantitative pharmacology for drug development.
• Contribute to regulatory submissions and scientific publications to enhance visibility.
• Mentor and manage junior staff, fostering professional growth and development.
• Implement innovative modeling and simulation techniques to optimize drug development processes.
• Ensure compliance with regulatory standards and adherence to safety policies.
• Evaluate new methodologies to maintain cutting-edge capabilities in clinical pharmacology.

Key Responsibilities & Duties

• Develop and implement pharmacometric strategies for drug development milestones.
• Serve as the subject matter expert on project teams for pharmacology-related topics.
• Conduct PK/PD analyses using advanced modeling techniques to support decision-making.
• Collaborate with internal and external experts to enhance drug development processes.
• Drive scientific visibility through publications and presentations.
• Ensure adherence to regulatory standards and compliance in clinical pharmacology programs.
• Mentor junior staff and contribute to departmental growth.
• Evaluate and implement new techniques to maintain innovative approaches in pharmacology.

Job Requirements

• PhD or PharmD in pharmaceutical sciences, pharmacology, or related discipline.
• Minimum 8 years of experience in clinical pharmacology and pharmacometrics.
• Proficiency in modeling software such as NONMEM and R for PK/PD analyses.
• Experience with regulatory submissions and oncology therapeutic area preferred.
• Strong leadership skills and ability to influence cross-functional teams.
• Knowledge of GLP and GCP regulations and compliance standards.
• Excellent communication and presentation skills for technical information.
• Ability to thrive in a fast-paced, matrixed environment and solve complex problems.