Head of Clinical Pharmacology

Proclinical; Town of Dover (NY); Presencial; USD 240.000 - 420.000; Jornada completa

Descripción de la vacante

Proclinical is seeking a Head of Clinical Pharmacology to lead clinical pharmacology and PD strategies for biologics development, guiding programs from FIH to regulatory submissions.

The successful candidate will shape pharmacology strategy, lead a PD team, and collaborate with global functions to advance oncology and immunology programs, with responsibility for FDA interactions and critical decision-making across development phases.

Formación

• Advanced degree in Clinical Pharmacology, Pharmacology, or related field.
• Proven track record with multiple FIH programs in biologics.
• Experience with FDA interactions and regulatory submissions.
• Leadership experience managing a PD/Clinical Pharmacology team.
• Expertise in PK-PD, dose optimization, and global development.
• Familiarity with FDA regulatory requirements and global programs.

Responsabilidades

• Lead the pharmacodynamics team and oversee clinical pharmacology strategies across programs.
• Design and execute FIH studies, dose-escalation and PK-PD assessments.
• Lead interactions with the FDA and contribute to IND and BLA submissions.
• Provide guidance on exposure-response modeling and dose selection.
• Collaborate with cross-functional teams to advance global development.

Conocimientos

PhD/PharmD/MD

Biologics development

FDA interactions

PD/Clinical pharmacology leadership

PK-PD modeling

Global development

Educación

PhD/MD/PharmD in relevant field

Clinical Pharmacology/related field

Experience in oncology/immunology programs

Descripción del empleo

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.