Manager, Clinical Pharmacology

EPM Scientific; Princeton (NJ); On-site; USD 130,000 - 150,000; Full time

Job summary

EPM Scientific in Princeton, New Jersey seeks a Manager / Senior Manager, Clinical Pharmacology to lead cross-program pharmacology efforts across development stages. The role focuses on PK/PD data integration, dose optimization, study design input, and strategic regulatory support.

The candidate will oversee external vendors and drive model-informed drug development, with at least 5 years in industry and a PhD/MD/PharmD or equivalent.

Qualifications

• PhD/MD/PharmD with 5+ years in industry.
• Experience leading pharmacology activities across development programs.
• Strong PK/PD and model-informed drug development knowledge.

Responsibilities

• Serve as the clinical pharmacology lead for development programs.
• Develop strategies to support objectives and regulatory requirements.
• Contribute to study protocols, SAPs, and regulatory documents.
• Interpret PK/PD and exposure–response data to inform decisions.
• Manage external vendors and CROs supporting pharmacology activities.

Skills

Clinical pharmacology

Pharmacokinetics

Pharmacodynamics

Dose optimization

Regulatory input

Education

PhD/MD/PharmD or equivalent

Job description

Manager, Clinical Pharmacology (PR/604132) Princeton, New Jersey

Salary: USD130000 - USD150000 per year

Title: Manager / Senior Manager, 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.