Clinical Pharmacology Director

Job Summary

A company is looking for a Director, Clinical Pharmacology & Pharmacometrics.

Key Responsibilities

• Develop clinical pharmacology strategies for multiple programs from candidate nomination through phase 4
• Support the development of clinical study protocols and conduct PKPD data analysis and interpretation
• Serve as the clinical pharmacology lead on cross-functional teams, managing dose selection and contributing to regulatory submissions

Required Qualifications

• PhD or MD with extensive experience in clinical pharmacokinetics and pharmacodynamics
• Strong understanding of clinical pharmacology and pharmacometrics principles
• Proficient in software for PK/PD analysis (e.g., Phoenix WinNonlin, R, ADAPT, NONMEM)
• Experience with regulatory submissions and agency interactions related to INDs, CTDs, NDAs, or BLAs
• Ability to work independently and collaboratively within cross-functional teams