Associate Director, Clinical Pharmacology

EPM Scientific; Princeton (NJ); On-site; USD 170,000 - 190,000; Full time

Job summary

Associate Director, Clinical Pharmacology at EPM Scientific in Princeton, New Jersey, leads clinical pharmacology strategy across development programs. You will apply PK/PD, dose–exposure–response insights and model-informed approaches to optimize dosing and study design, informing key regulatory decisions.

The role requires a PhD/MD/PharmD or equivalent with 5+ years in industry, and a proven track record across multiple clinical phases.

Qualifications

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology or related field.
• Minimum 5 years of industry experience in clinical pharmacology or related function.
• Experience leading activities across multiple development programs and phases.

Responsibilities

• Serve as the clinical pharmacology lead for development programs.
• Develop and implement clinical pharmacology strategies to support objectives and regulatory requirements.
• Provide input into study protocols, SAPs, CSRs, and regulatory documents.
• Lead interpretation of PK, PD, exposure–response, and translational data to inform decisions.
• Evaluate dose selection strategies and recommend regimens based on data.
• Contribute to regulatory submissions and responses to authorities.
• Oversee external vendors and CROs supporting pharmacology activities.

Skills

PK/PD modeling

Dose optimization

Clinical pharmacology

Education

PhD/PharmD/MD

Job description

Associate Director, Clinical Pharmacology (PR/604132) Princeton, New Jersey

Salary: USD170000 - USD190000 per year

Title:Associate Director, Clinical Pharmacology

This pharmaceutical company is seeking an experienced Clinical Pharmacologist to provide strategic and scientific leadership across multiple drug development programs. A successful candidate will leverage pharmacokinetic (PK), pharmacodynamic (PD), and quantitative clinical pharmacology principles to inform key development decisions, including dose optimization, study design, and benefit-risk assessments.

Key Responsibilities:

• Serve as the clinical pharmacology lead for one or more development programs across various stages of clinical development.
• Develop and implement clinical pharmacology strategies that support program objectives and regulatory requirements.
• Provide scientific input into clinical study protocols, statistical analysis plans, clinical study reports, investigator brochures, and regulatory documents.
• Lead the interpretation and integration of PK, PD, exposure-response, and translational data to support development decisions.
• Evaluate dose selection strategies and recommend dosing regimens based on available preclinical and clinical data.
• Author, review, and contribute to clinical pharmacology sections of regulatory submissions and responses to health authorities.
• Manage and oversee external vendors, consultants, and contract research organizations supporting clinical pharmacology activities.

Qualifications:

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum of 5 years of industry experience in clinical pharmacology or a closely related function within biotechnology, pharmaceutical, or life sciences organizations.
• Demonstrated experience leading clinical pharmacology activities for development programs across multiple clinical phases.
• Strong understanding of pharmacokinetics, pharmacodynamics, dose-exposure-response relationships, and model-informed drug development principles.