Clinical Pharmacology Lead

Job Summary

Seeking a Clinical Pharmacology Lead, the full-time remote position will manage the design and execution of Clinical Pharmacology development strategies for new and approved drugs, ensuring compliance with regulatory requirements and collaborating with cross-functional teams.

Key responsibilities

• Develop and implement Clinical Pharmacology strategies, including pharmacokinetic/pharmacodynamic assessments and drug interaction evaluations
• Act as a Clinical Pharmacology representative in project teams and regulatory meetings, contributing to early development milestones
• Engage with regulatory agencies and contribute to official documentation for drug submissions and clinical trial protocols

Required qualifications

• Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences, or Clinical Pharmacology, or a Master's degree with relevant experience
• Experience using NONMEM software for pharmacometric analysis
• Strong knowledge of pharmacokinetics, pharmacodynamics, and clinical drug development regulatory guidelines
• Ability to lead and facilitate meetings and develop training related to Clinical Pharmacology topics
• Proven track record of teamwork and effective interaction with internal and external stakeholders