Head of Clinical Pharmacology

Head of Clinical Pharmacology - Permanent - Dover, United States

Ready to lead the clinical pharmacology strategy behind next-generation biologics and shape breakthrough therapies from First-in-Human studies to regulatory approval?

Proclinical is seeking a Head of Clinical Pharmacology to lead clinical pharmacology and pharmacodynamics (PD) strategies for biologics development.

The successful candidate will play a pivotal role in shaping clinical pharmacology strategies, collaborating with cross-functional teams, and driving global development programs. This role focuses on advancing innovative therapies in oncology and immunology from First-in-Human (FIH) studies through regulatory submissions.

• Advanced degree (PhD, PharmD, MD, or equivalent) in Clinical Pharmacology, Pharmacology, or a related field.
• Strong experience in biologics development, including a proven track record with multiple FIH programs.
• Demonstrated expertise in FDA interactions and direct involvement in BLA submissions.
• Leadership experience managing or leading a PD or Clinical Pharmacology team.
• Proficiency in PK-PD, dose optimization, and global clinical development.
• Preferred:
  Experience with innovative biologics, FDA regulatory requirements, and global drug development programs.

• Lead the pharmacodynamics team and oversee clinical pharmacology strategies across development programs.
• Design and execute FIH studies, dose-escalation strategies, dose optimization, and PK-PD assessments.
• Lead interactions with the FDA and contribute to IND and BLA submissions.
• Provide scientific guidance on PK-PD modeling, exposure-response analysis, and dose selection.
• Collaborate with clinical, regulatory, and cross-functional teams to advance global development programs.