Director Of Pharmacometrics – Clinical Pharmacology

Overview

• Lead pharmacometrics initiatives within the Clinical Pharmacology function to advance Model-Informed Drug Development (MIDD) strategies.
• Develop workflows and systems to deliver quantitative clinical pharmacology results effectively.
• Collaborate with cross-functional teams to enhance drug development processes and innovation.
• Provide scientific leadership and mentorship to pharmacometrics staff, fostering excellence in modeling approaches.
• Ensure impactful communication of pharmacometric results to diverse audiences, including regulatory authorities.
• Promote scientific visibility through conference presentations and peer-reviewed publications.
• Establish and maintain external networks to support advanced pharmacometric analyses.
• Drive innovation and alignment across drug development initiatives within the organization.

Key Responsibilities & Duties

• Accountable for pharmacometric deliverables, ensuring scientific quality and timeliness.
• Guide pharmacometric strategies for regulatory submissions and health authority inquiries.
• Support communication of MIDD strategies across organizational levels and functions.
• Collaborate with Clinical Pharmacology colleagues to improve efficiency and innovation.
• Develop training programs to strengthen pharmacometric capabilities within the organization.
• Promote scientific visibility through external presentations and publications.
• Maintain external networks for specialized pharmacometric analyses.
• Advance MIDD standards by incorporating best practices from the scientific community.

Job Requirements

• PhD preferred in Pharmacometrics or related field; MS or PharmD applicable.
• Minimum 10 years of pharmaceutical industry experience in pharmacometrics or quantitative clinical pharmacology.
• Proficiency in pharmacometric software tools such as NONMEM, R-studio, and Julia/Pumas app.
• Expertise in MIDD strategies and their application to drug development.
• Experience in preparing strategic regulatory documents and health authority responses.
• Leadership experience in developing pharmacometric and communication skills within a team.
• Strong collaboration skills with cross-functional teams to enhance drug development processes.
• Proficient in MS Office Suite and pharmacometric modeling tools.