Head of Clinical Pharmacology

Lead Clinical Pharmacology Strategy for Next-Generation Biologics

Shape breakthrough therapies from First-in-Human studies to regulatory approval by leading clinical pharmacology and pharmacodynamics (PD) strategies for biologics development. This pivotal role focuses on advancing innovative therapies in oncology and immunology, collaborating with cross-functional teams, and driving global development programs.

Key Responsibilities

• Lead the pharmacodynamics team and oversee clinical pharmacology strategies across development programs.
• Design and execute First-in-Human (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.

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