[innovative Medicine] Senior Manager, Oncology, Clinical Science

Johnson & Johnson Innovative Medicine

Chiyoda, Japan
**
Clinical development strategy
Oncology clinical studies
Pmda/mhlw interactions
** Johnson & Johnson Innovative Medicine is seeking a Senior Manager for Oncology Clinical Science in their Tokyo or Osaka office. The role involves leading clinical development strategies, ensuring the execution of oncology clinical studies, and providing mentorship within a global clinical team setting. **

Job Summary

  • Act as JP clinical lead of a matrix team to provide JP insights and clinical expertise to develop a global clinical development strategy.
  • Lead the clinical part of PMDA/MHLW interactions and responsible for clinical related regulatory document development.
  • Provide support for clinical study/studies within a development program including comprehensive medical monitoring and detailed, real time review of serious adverse events and deaths.

Matching Summary

Match Score: 75

** Johnson & Johnson Innovative Medicine is seeking a Senior Manager for Oncology Clinical Science in their Tokyo or Osaka office. The role involves leading clinical development strategies, ensuring the execution of oncology clinical studies, and providing mentorship within a global clinical team setting. **

Skills & Requirements

Must-have

  • Clinical development strategy
  • Oncology clinical studies
  • PMDA/MHLW interactions
  • Medical monitoring
  • Data review and query resolution
  • Global clinical team collaboration

Nice-to-have

  • Lung, GI, and/or H&N oncology experience
  • New Drug Application (NDA) submission experience
  • External clinical research assessment
  • Independent Data Monitoring Committee interaction

Key Requirements

  • B.S. or above in biology, pharmacology or related scientific specialties
  • Minimum of 10 years of clinical research experience
  • Knowledge of Good Clinical Practices and regulatory requirements
  • Fluency in English and native-level proficiency in Japanese

Work Rights

Not specified

Tailored Resume

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