About this opportunity
Proclinical lists this Head of Clinical Pharmacology opportunity in dover, Delaware. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
dover, DE, 19904, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.