Head of Clinical Pharmacology

Confidential

Dover, DE

Head of Clinical Pharmacology

About the Company

Biologics developer advancing oncology and immunology therapies through clinical development and regulatory approval

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is in search of a Head of Clinical Pharmacology to spearhead the strategic development of next-generation biologics and breakthrough therapies. The successful candidate will be responsible for shaping and leading clinical pharmacology and pharmacodynamics strategies, with a focus on advancing innovative therapies in oncology and immunology from First-in-Human studies to regulatory approval. This pivotal role involves collaboration with cross-functional teams, driving global development programs, and overseeing the design and execution of FIH studies, dose-escalation strategies, and PK-PD assessments. Applicants for the Head of Clinical Pharmacology position at the company should possess an advanced degree in a relevant field and have a strong background in biologics development, including a proven track record with multiple FIH programs. Expertise in FDA interactions, particularly in BLA submissions, and leadership experience in managing a PD or clinical pharmacology team are essential. The role also requires proficiency in PK-PD, dose optimization, and global clinical development, with a preference for candidates who have experience with innovative biologics and a deep understanding of FDA regulatory requirements. The Head of Clinical Pharmacology will be at the forefront of scientific guidance, providing input on PK-PD modeling, exposure-response analysis, and dose selection, and will play a key role in advancing global development programs through collaboration with clinical, regulatory, and cross-functional teams.

Functions

Data Management/Analytics
Strategy

Confidential

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Vacancy posted 5 days ago

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