Clinical Pharmacology Director

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