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.
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: Experience with innovative biologics, FDA regulatory requirements, and global drug development programs.
The Head of Clinical Pharmacology's responsibilities will be:
- 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 having difficulty in applying or if you have any questions, please contact Siya Sun at s.sun@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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