Head of Clinical Pharmacology

Proclinical; Dover (DE); On-site; USD 180,000 - 240,000; Full time

Job summary

Proclinical is seeking a Head of Clinical Pharmacology to lead clinical pharmacology and pharmacodynamics (PD) strategies for biologics development, spanning First-in-Human studies to regulatory submissions. The role involves shaping pharmacology strategies across oncology and immunology programs and collaborating with cross-functional teams globally.

The ideal candidate will have an advanced degree and proven leadership in PD, with expertise in PK-PD modeling, dose optimization, and regulatory

Qualifications

• Advanced degree in Clinical Pharmacology, Pharmacology, or related field.
• Strong experience in biologics development with multiple FIH programs.
• Direct involvement in FDA interactions and in BLA submissions.

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.

Skills

Biologics development experience

FDA interactions

PK-PD expertise

Leadership in PD/Clinical Pharmacology

Dose optimization

Global clinical development

Education

PhD/PharmD/MD in Clinical Pharmacology or related

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.