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Pharmacy Manager / Director
Princeton, NJ
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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.
