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Pharmacokinetics Researcher

Employer
Santen, Inc.
Location
Nara, Japan, Japan
Start date
Jul 18, 2019

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Discipline
Science/R&D, Research
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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.

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
 United States
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