Clinical Pharmacology Consultant

Job Summary

Seeking an experienced Clinical Pharmacology Consultant for a part-time contract role, the consultant will provide expertise on human PK/PD, ensuring AI-generated clinical pharmacology outputs meet regulatory standards while working remotely for 5-20 hours per week.

Key responsibilities

• Share knowledge on the daily operations of clinical pharmacology and regulatory submissions
• Identify tasks where AI can enhance workflows and describe common internal pharma systems
• Generate or review reference artifacts and identify discrepancies in data quality

Required qualifications

• 10+ years of experience in clinical pharmacology, preferably at a sponsor
• PhD, PharmD, or MD preferred
• Hands-on experience with exposure-response and population PK analyses for regulatory submissions
• Experience authoring or reviewing clinical pharmacology sections of INDs, IBs, CSRs, and NDA/BLA modules
• Direct experience responding to regulatory agencies