Senior Japan Project Lead

Sanofi

Tokyo, Japan
Not specified
Extensive project leadership experience
Clinical trial operations expertise
Japanese new drug application filing
Sanofi is seeking a Senior Japan Project Lead in Tokyo to oversee the end-to-end development of pharmaceutical projects, ensuring alignment with global strategies and local regulations. The ideal candidate will possess extensive experience in project leadership and drug development, particularly in managing regulatory processes and cross-functional collaboration

Job Summary

  • The Senior Japan Project Lead serves as the project owner with full independence for end-to-end development pipelines from early stages to product launch.
  • This role requires leading the Japan Project Team and collaborating with global stakeholders to align development strategies with local market conditions.
  • Candidates must demonstrate extensive experience in creating Clinical Study Reports, filing Japanese New Drug Applications, and preparing for PMDA milestone meetings.

Matching Summary

Match Score: 85

Sanofi is seeking a Senior Japan Project Lead in Tokyo to oversee the end-to-end development of pharmaceutical projects, ensuring alignment with global strategies and local regulations. The ideal candidate will possess extensive experience in project leadership and drug development, particularly in managing regulatory processes and cross-functional collaboration.

Skills & Requirements

Must-have

  • Extensive project leadership experience
  • Clinical trial operations expertise
  • Japanese New Drug Application filing
  • PMDA/MHLW milestone meeting preparation
  • Fluency in written and spoken Japanese
  • Fluency in written and spoken English

Nice-to-have

  • Experience in immunology-oncology therapeutic areas
  • Digital projects experience preferred
  • Local medical or clinical setting experience
  • Cross-functional work with medical and commercial teams
  • Master's degree, PhD, or MD qualification
  • Innovative mindset and problem-solving skills

Key Requirements

  • Minimum of 5 years in drug development
  • Bachelor's degree in life sciences required
  • Advanced degrees (Master's/PhD/MD) highly preferable
  • Proven track record in J-NDAs and regulatory filings
  • Interdisciplinary understanding of CMC, PK, and Clinical disciplines

Work Rights

Not specified

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