Manager, Clinical Pharmacology
Title: Manager / Senior Manager, Clinical Pharmacology
Location: Princeton, New Jersey (Hybrid)
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.
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