[innovative Medicine] R&d, Senior Principal Scientist, Pharmacology Group, Preclinical Science &translational Safety Japan

J&J FAMILY OF COMPANIES

Chiyoda, Tokyo, Japan
Not specified
Nonclinical data integration
Regulatory submission preparation
Toxicology and pharmacology expertise
Johnson & Johnson is seeking a Senior Principal Scientist for their Pharmacology Group in Tokyo, Japan, focusing on nonclinical submissions within Preclinical Science and Translational Safety. The role requires extensive experience in toxicology, safety pharmacology, and DMPK to ensure high-quality regulatory submissions for drug development, while also fostering collaboration and innovation within the team

Job Summary

  • You will lead the preparation and review of high-quality nonclinical sections for global regulatory submissions, ensuring compliance with Japanese and international standards.
  • The role involves close collaboration with internal and external experts to develop scientific narratives and risk assessments that support drug development pipelines.
  • You will provide coaching and scientific feedback to team members while shaping regulatory acceptance through external and industry activities.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Principal Scientist for their Pharmacology Group in Tokyo, Japan, focusing on nonclinical submissions within Preclinical Science and Translational Safety. The role requires extensive experience in toxicology, safety pharmacology, and DMPK to ensure high-quality regulatory submissions for drug development, while also fostering collaboration and innovation within the team.

Skills & Requirements

Must-have

  • nonclinical data integration
  • regulatory submission preparation
  • toxicology and pharmacology expertise
  • global regulatory knowledge
  • scientific coaching and mentoring
  • AI-enabled document preparation
  • collaboration with global teams

Nice-to-have

  • advanced presentation skills
  • negotiation and influencing skills
  • strategic scientific planning
  • cross-functional relationship building
  • self-management and development

Key Requirements

  • 15+ years nonclinical experience
  • expertise in biology, toxicology, pharmacology, DMPK
  • advanced knowledge of IND/NDA processes
  • advanced knowledge of Japanese/EU/US regulations
  • advanced English communication skills

Work Rights

Not specified

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