The Clinical Development Division aims to establish top-level development frameworks in Japan and overseas, use cutting-edge science to design optimal clinical development plans based on evidence obtained in the drug discovery stage, and implement speedy clinical trials to obtain approval of pharmaceuticals.
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• Entrance requirements: Students specializing in pharmaceuticals, science, and engineering

Clinical Development Positions

[Planning/Promotion]
The Clinical Development Division works with the aims of establishing top-level development frameworks in Japan and overseas, using cutting-edge science to design optimal clinical development plans based on evidence obtained in the drug discovery stage, and implementing speedy clinical trial for obtaining approval of pharmaceuticals.

[Biostatistics Specialist]
These positions have final responsibility for the statistical aspects of new drug development and apply statistical methods to contributions at all stages, from development strategy planning for new drugs to obtaining approval. In recent years, new approaches have become necessary to produce findings with the statistical processing of data from individual divisions. This position involves collaboration with divisions outside Clinical Development, provision of statistics training, and consulting work.

[Data Management (DM)]
This position involves accurate and efficient management of data quality for appropriate data-based decision-making in clinical trials. In recent years, new initiatives have been launched, including the use of new technology for data collection and evaluation and the use of data from medical care information databases.

Clinical Pharmacology Positions

Clinical pharmacology contributes to the success of new drug development by making full use of predictive science to set the appropriate patient profile, dosage and administration. Specifically, these positions contribute to efficient development of new drugs through various tasks, such as the development of advanced measuring methods that contribute to the clarification of pharmacokinetics and biomarker discovery, predictions using modelling and simulation, and the selection of appropriate patients and provision of information based on biomarkers and clinical pharmacological trials.

Safety Positions

The Drug Safety Division is a critical organization in any pharmaceutical company and could be described as the heart of the company. To obtain the reassurance and confidence of patients, it analyzes safety data from development through to post-market from a global perspective and takes urgent action, such as reporting to the regulatory authorities and providing information to medical professionals. 

Reliability Assurance Positions

These positions play a leading role in cross-divisional projects/tasks for ensuring the reliability of information regarding the quality, efficacy, and safety of products under development and of finished products, and for solving issues related to compliance with pharmaceutical legislative systems. They promote continuous improvement initiatives by establishing frameworks and the development of IT systems for processes related to ensuring reliability.

Quality Assurance Positions

These positions have final responsibility for the quality of products shipping to market. They control quality maintenance and improvement activities through compliance with manufacturing-related regulations in Japan and overseas, operation of integrated quality systems from development to commercial production, and the management and supervision of factories. 

Technical Regulatory Experts

These positions play a leading role in the handling of new drug applications and reviews, as well as other various tasks, including negotiations with regulatory authorities, collection, analysis, evaluation, and provision of regulatory information regarding pharmaceuticals, and the production and amendment of package inserts. Other duties include overseas technical regulatory responses, as well as editing, compilation, and management of application documentation for new drugs.

Domain-specific Scientific Positions

With the goal of changing the treatment of current patients for the better, staff in these positions confront the constantly changing nature of healthcare and science, thinking the issues through to the end and taking action until they reach an outcome, to deliver highly scientific data and information that will help to create a brighter future for patients.

Read interviews with employees working
in clinical development positions

Possessing a high degree of academic expert knowledge and a superior sense of ethics, they are pharmaceutical specialists and pharmaceutical company sales representatives who provide information to hospitals, clinics, and pharmacies, etc. and collect information from them regarding the efficacy and safety, etc. of their company’s products. Responding flexibly to change in the medical care environment, each individual MR enhances their own specialty.

• Entrance requirements: Students specializing in pharmaceuticals, science, and humanities

Read interviews with employees working in MR positions