Clinical Pharmacology Associate Director

Job Summary

Providing clinical pharmacology input into all phases of drug development, the full-time remote Clinical Pharmacology Associate Director will support clinical study design, execution, and regulatory submissions across various therapeutic areas.

Key responsibilities

• Lead clinical pharmacology activities related to study design, protocol development, and data interpretation
• Author clinical pharmacology sections in regulatory documents and represent the department in product development meetings
• Collaborate with cross-functional teams to support pharmacometrics strategies and model-based drug development

Required qualifications

• PhD, PharmD, or MS in Clinical Pharmacology or a related field with a minimum of 4 years of industry experience
• In-depth knowledge of clinical pharmacology, PK, PD, and drug metabolism
• Hands-on experience in PK and PK/PD analysis using relevant software
• Strong understanding of phase I clinical operations and regulatory requirements
• Experience in population PK and PK/PD modeling is a plus