Associate Director, Pharmacometrics - NLME modeling

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 three 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.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

This individual will be responsible for developing and executing the pharmacometric strategies in clinical and translational projects to support the overall clinical pharmacology and team decision-making capabilities. The company has a focus in in the immuno-oncology, nephrology, immunology, oncology, and/or neuroscience therapeutic areas and programs encompass small molecule and biologic drugs.

Essential Functions:

Advanced R & NLME mixed effects model programming, Mechanistic modeling, NONMEM, Clinical trial simulation and supporting the development of standardized internal pharmacometric workflows.

Requirements:

The role requires experience in development of R programs and NONMEM control files to facilitate streamlined analyses and reporting associated with regulatory compliant pharmacometric workflows. 
Additionally, prior experience with quantitative systems pharmacology approaches and physiologically base pharmacokinetics analysis utilization 
-and/or- 
Additional tools for NLME analysis and knowledge of transferring MMRM SAS analyses into R or Julia, and experience using Clinical trial simulations with probability of success metrics are highly useful.
Further, experience developing R shiny applications, non-compartmental analysis of pharmacokinetics, and modeling of population pharmacokinetics and exposure response analysis useful.  
Ideal candidate will have documented broad experience across sub-disciplines of quantitative pharmacology & methodology

Education
Ph.D. degree in Bio-engineering, Systems Pharmacology, Mathematics, Applied Statistics, Computer Science, Pharmacometrics

Experience
At least 10 years in pharmaceutical industry
At least 5 years of experience with R or Julia programming
At least 5 years of experience with NONMEM programming and NLME analysis of pharmacokinetics and pharmacodynamics
Knowledge of and experience with the development of pharmacometric workflows
Experience projecting activity timelines and meeting deliverables in timely manner
Understanding of model informed drug development approach and application to regulatory strategy
Exposure to or experience with current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, time-series biostatistical approaches
Experience with R Shiny application development applied to data visualization and clinical trial simulations

Technical Skills
Proficiency in R language programming
Proficiency with pharmacometric software tools: NONMEM, Open Systems Pharmacology Suite, Pumas, Matlab, SimCyp
Proficiency in writing technical reports

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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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