Pharmacokinetics Researcher

Location
Nara, Japan
Posted
Oct 16, 2019
Ref
ovqlafwa
Required Education
Bachelors Degree
Position Type
Full time
PRIMARY PURPOSE OF POSITION:

Responsibilities of this position are as follows:

This position has to plan and execute pharmacokinetics studies for each project/theme of ophthalmic pharmaceutical products and provide reliable scientific data as a "Practice Leader of Pharmacokinetics". And also, it has to make pharmacokinetics section of dossier for submission (INDs, NDAs and MAAs) under the supervision of Senior Researcher and/or Group Manager.

In addition, this position should establish new technologies of pharmacokinetics for promotion and problem solving of themes/project.

Also, the position is expected to take on a wider range of research and management tasks as the Senior Researcher of the Pharmacokinetcs team in the future.

MAJOR DUTIES OF POSITION:
  • Participating in the team-based activities as a pharmacokinetic researcher in the research and development of new products and LCM/GE products.
  • Planning and execution of the pharmacokinetic study required for product development in charge.
  • Making pharmacokinetics section of dossier for submission (INDs, NDAs and MAAs).
  • Biomarker measurement in Translational Research.
  • Proposal and implementation of new technology development for pharmacokinetics.
  • Development of junior members through day-to-day operations to improve their skill.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum 8 years of relevant pharmaceutical development experience.
  • Strong background and experience in pharmacokinetics including submission of pharmaceutical products.
  • Knowledge and skills of in vitro/in vivo studies, bioanalytical, model & simulations and drug delivery systems.
  • Experience in early and late stage pharmaceutical development with thorough knowledge of ICH and relevant guidelines and regulations including GLP.
  • Speaking fluent Japanese.