Director Clinical Pharmacology And Pharmacometrics

Overview

• Lead clinical pharmacology and pharmacometrics initiatives to advance innovative drug development strategies and therapeutic solutions.
• Collaborate with interdisciplinary teams to integrate pharmacokinetics and pharmacodynamics into comprehensive development plans.
• Provide expert guidance in quantitative pharmacology to optimize therapeutic efficacy and regulatory submissions.
• Mentor and develop team members, fostering a culture of excellence and continuous learning.
• Implement advanced modeling and simulation techniques to enhance drug development processes.
• Ensure compliance with regulatory standards and maintain adherence to safety protocols.
• Contribute to scientific publications and presentations to establish thought leadership in clinical pharmacology.
• Evaluate and adopt innovative methodologies to maintain competitiveness in pharmacology practices.

Key Responsibilities & Duties

• Develop and execute pharmacometric strategies to achieve critical drug development milestones.
• Serve as a subject matter expert in pharmacology, providing insights to cross-functional teams.
• Conduct PK/PD analyses using advanced modeling software to inform strategic decision-making.
• Collaborate with internal and external stakeholders to enhance drug development processes.
• Drive scientific visibility through impactful publications and conference presentations.
• Ensure compliance with regulatory standards in clinical pharmacology programs.
• Mentor junior staff and contribute to the growth of the pharmacology department.
• Evaluate and implement innovative techniques to maintain cutting-edge pharmacology practices.

Job Requirements

• PhD in pharmaceutical sciences, pharmacology, or a related discipline.
• Minimum of 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, preferably in oncology therapeutic areas.
• Strong leadership and team management skills to influence cross-functional teams.
• Knowledge of GLP and GCP regulations and compliance standards.
• Excellent communication and presentation skills for conveying technical information.
• Ability to thrive in a fast-paced, matrixed environment and address complex challenges.