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Sr. Manager of PKPD

Company: Luye Pharma USA Ltd.
Location: Princeton
Posted on: January 15, 2022

Job Description:

Luye Pharma is seeking a pharmacokineticist to join the global Clinical Development team based in Princeton, NJ Office.

Responsibilities:
hands-on design, conduct, interpretation, and reporting of pharmacokinetic study and the result
provide pharmacokinetic expertise and support across therapeutic areas including CNS, oncology, DM and CVS
Assist medical monitor in overall clinical development strategy, design of specific clinical pharmacology/pharmcokinetic studies including the design of modelling and simulation-based assessments for Luye's clinical projects
Collaborate with medical monitor and clinical operation in evaluation of Contract Research Organization (CRO) capabilities. Actively participate in review and monitoring of outsourced PK/PD-related activities
Work in close collaboration with Biostatistics and Programming group
Develop/author/review (including QC) relevant components for various internal documents and presentations
Support projects in all development stages using mechanism-based modelling & simulation methodologies
Collaborate with preclinical PKPD department in addressing critical PK and PK/PD related questions, enable time-appropriate decision-making for clinical development programs

Requirements:
A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology or related fields with a specific focus on pharmacokinetics
Minimal 5 years of pharmaceutical industry experience in conduct of pharmacokinetic support
Extensive experience with quantitative approach in describing PK/PD systems using preclinical and clinical data and demonstrated ability to apply quantitative tools to enable rational and efficient drug development are required
Proficiency in WinNonlin/Phoenix is preferred; experience in NONMEM and/or other modeling and simulation software is required
Broad experience in mechanism-based PK/PD research of biologic therapeutics is strongly preferred
Experience in supporting interdisciplinary projects

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Keywords: Luye Pharma USA Ltd., Trenton , Sr. Manager of PKPD, Executive , Princeton, New Jersey

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