Sr. Manager of PKPD

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