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Sr. Manager of PKPD

LUYE PHARMA USA LTD Princeton ,NJ
  • Posted: over a month ago
  • Full-Time
  • Benefits: 401k, dental, life_insurance, medical, vision
Job Description
  • 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
  • Review (including QC) relevant components for various internal data and 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
  • A PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences with at least 2 years of experience, or a MS in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences with at least 7 years of experience is required.
  • Extensive experience with quantitative approach in describing PK/PD systems using preclinical and/or clinical data and demonstrated ability to apply quantitative tools to enable rational and efficient drug development are required
  • Proficiency in WinNonlin/Phoenix is required; NONMEM and/or other advanced modeling and simulation software is preferred
  • Broad experience in mechanism-based PK/PD research of biologic therapeutics and/or small molecule therapeutics is strongly preferred
  • Experience in biologics and/or small molecules drug development is preferred
  • A strong publication record is highly preferred

LUYE PHARMA USA LTD

Address

502 Carnegie Center Drive
Princeton, NJ
USA

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