Chief Clinical Pharmacology & PD Strategy Lead (Biologics)

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

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