Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.
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 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 effectively communicate scientific MIDD strategies and results to a wide range of audiences, internally and externally
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
Proficiency in pharmacometric software tools for non-linear mixed effects modeling, data manipulation and preparation, physiologically based pharmacology, and systems pharmacology modeling.
Experience with Microsoft Office, including Word, Excel, Power
Point, Project, Articulate, and ability to learn new systems.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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