[Innovative Medicine] R&D, Senior Principal Scientist, Pharmacology Group, Preclinical Science &Tran

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Nonclinical Safety

Job Category:
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

As a Principal/Senior Principal Scientist responsible for nonclinical submissions within Preclinical Science and Translational Safety (PSTS), you will integrate nonclinical data-including toxicology, safety pharmacology, and DMPK-and lead the high‑quality and timely preparation and review of nonclinical sections for regulatory submission documents intended for global health authorities.

You will collaborate with internal and external experts to develop clear scientific narratives and risk assessments, and work closely with the global dossier team to contribute to pipeline advancement across therapeutic areas

JOB SUMMARY:

1.

Conduct 1) to 4) below in the non-clinical area with global mind set.

1) Ensure appropriate studies are conducted at appropriate times to support drug development in Japan

2) Ensure study results and their interpretation meet Japanese regulatory requirements.

3) Ensure resolution to all project-related problems that might affect development in Japan.

4) Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines by using modern approaches, including AI.

2.

Focus on self-evaluation, self-management and self-development.

3.

Scientific educate and coach the members.

4.

Make close/tight relationships with Global team and plan/execute strategy of scientific/regulatory matters

5.

Shape regulatory acceptance aligned with international standards through external/industry activities.

KEY RESPONSIBILITIES:

1.

Conduct 1) to 9) below in the non-clinical area with global mind set.

1) Research global documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDAs.

2) Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate reso...