Manager, Pharmacometrics

  • Job Reference: 425086156-2
  • Date Posted: 17 November 2021
  • Recruiter: Kyowa Kirin, Inc.- U.S.
  • Location: Princeton, New Jersey
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent

Job Description

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, including receiving the COVID-19 vaccine as 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. The decision has been made to require 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:
The Manager of Pharmacometrics role has the responsibility to develop and execute the modeling and simulation strategy for clinical projects in close collaboration with cross-functional teams. It is expected the incumbent will proactively advocate the use of model-based approaches to support the overall clinical pharmacology development strategy and team decision-making capabilities. Clear communication of the modeling and simulation strategy and results to key team members is expected. The role would encompass working on programs across small molecule and biologic drugs in the oncology, nephrology, immunology and/or neuroscience therapeutic areas.

The candidate would be expected to facilitate the implementation of modeling and simulation into team decisions by using standard Non-Linear Mixed Effects (NLME) modeling of pharmacokinetic and pharmacodynamic relationships. Further, consideration of novel problem solving for unique quantitative pharmacology questions would be needed based on the differentiation of assets and the competitive landscape. The ideal candidate will work independently to facilitate decisions impacting modeling and simulation goals, to analyze data from different sources as business needs dictate, and to publish manuscripts and present at scientific conferences.

The incumbent will proactively incorporate and develop approaches and methodologies of current scientific literature and strengthen Kyowa Kirin modeling and simulation capabilities through continuous evaluation of new tools and standardization of internal workflows. When appropriate, the individual would lead external analyses following vendor selection and evaluation. The candidate should actively contribute to the Kyowa Kirin's passion and innovation to bring new
products to patients!

Essential Functions:
  • NLME modeling of PK, PK/PD and exposure response analyses.
Requirements:
Education:
  • MS (2-5 yr post-graduate) or PhD (0-2 yr post-graduate) degree in Mathematics, Statistics, Engineering, or Pharmacometrics
Experience:
  • Experience and understanding of using modeling and simulation approaches to solve unique problems, ideally with solving drug development challenges
  • Thorough knowledge of planning, conducting, and reporting modeling and simulation analyses in a research and/or drug development setting
  • Proven experience in identifying research projects and execution of a pharmacometrics strategy
  • Experience projecting activity timelines and meeting deliverables in timely manner
  • Exposure to or experience with current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, time-series biostatistical approaches
Technical Skills:
  • Hand on experience with NLME modeling and simulation tools
  • Proficiency with R/SAS and/or other programming languages, desire to learn new programming languages based on project needs
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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