Head of Clinical Pharmacology / Head of Clinical Pharmacology

Head of Clinical Pharmacology - Permanent - Dover, United States

Are you 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 spearhead clinical pharmacology and pharmacodynamics (PD) strategies for biologics development.

Primary Responsibilities

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.

Skills & Requirements

• 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 Qualifications

• Experience with innovative biologics, FDA regulatory requirements, and global drug development programs.

Key Responsibilities

• 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.

If you are interested in this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.