Clinical Pharmacology Director

Job Summary

A company is looking for a Director of Clinical Pharmacology.

Key Responsibilities

• Lead multidisciplinary teams to develop clinical pharmacology strategies for drug development and regulatory decisions
• Innovate and implement clinical pharmacology approaches and leverage quantitative modeling for clinical trial designs
• Represent clients in meetings with global health authorities and contribute to regulatory submission documents

Required Qualifications

• PhD or PharmD in pharmacology, pharmacokinetics, or related scientific discipline; MS in Pharmaceutical Science with relevant experience may be considered
• 7 - 12+ years of clinical pharmacology experience in the pharmaceutical industry or government
• Experience with small and biologic molecule therapeutics and regulatory submissions (e.g., INDs, NDAs, BLAs)
• Proven track record in cross-functional drug development teams and leading successful teams
• Working understanding of CMC, pharm/tox, biostats, and clinical requirements in drug development