Seeking a Senior Manager, Pharmacometrics to join the Clinical Pharmacology Team at a GLOBAL pharmaceutical!Description:The Senior Manager, Pharmacometrics will be responsible for performing hands-on analyses to support model informed drug development (MIDD) decision making for Kyowa Kirin’s biologics and small molecule assets. The Senior Manager will perform dataset programming, exploratory data analysis, and modeling and simulation analyses using their understanding of biology as applied to quantitative approaches and clinical pharmacology. The Senior Manager is expected to communicate effectively and clearly within Clinical Pharmacology, with cross-functional teams and external pharmacometrics vendors, and to external audiences in support of advancing the development pipeline.
Generate modeling and simulations plans, and conduct population pharmacokinetic and exposure-response analyses.
Prepare modeling and simulations analyses reports and review pharmacometric components of regulatory submission documents.
Build on the current standards for MIDD analyses for continued improvement of workflows and processes.
Globally collaborate with cross-functional teams and external pharmacometrics vendors, and effectively communicate scientific MIDD strategies and results to a wide range of audiences, internally and externally
Skills:R, nonmem, pharmacometrics, PK, PD, pharmacokinetics, pharmacodynamicsAdditional Skills & Qualifications:
Education - Advanced Degree in related field (Ph.D., PharmD, or master’s)
2-3 years of experience with nonlinear mixed effects modeling of pharmacokinetics (PK) and pharmacodynamics (PD), or a post-doctoral experience in related field
Experience using NONMEM and/or other modeling and simulations software.
Proficiency with R or Julia programming
Experience with mechanistic and/or translational PK/PD modeling and simulations a plus
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