[Innovative Medicine] R&D, Group Manager(Sr. Principal Scientist), Pharmacokinetics & Drug Metabolis

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

JOB SUMMARY:

1.

Conduct 1) to 4) below in the non-clinical area.

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

2) Ensure study results and their interpretation meet Japanese 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.

2.

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

3.

Educate and coach the group members and make proper assignments and fair performance appraisals.

4.

Plan and execute strategy of the group

5.

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

KEY RESPONSIBILITIES: List major responsibilities and duties of the position.

1.

Conduct 1) to 9) below in the non-clinical area.

1) Research global (e.g.

JJPRD) 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 NDA's.

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

additional studies and/or documentation) into practice.

3) Prepare high-quality non-clinical documents for clinical studies and/or NDAs.

4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with global, JPKK and/or external experts.

5) Provide support for preparing high-quality documents for marketing.

6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed.

7) Provide relevant colleagues with suggestions from non-clinical perspectives.

8) Establish, maintain and improve relationshi...