Global Clinical Development Strategy Expert

Sanofi

Tokyo, Japan
Clinical development strategy
Protocol development
Regulatory authority interactions
The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate

Job Summary

  • The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.
  • The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards.
  • The GCDSE establishes the conditions essential for determining the safety of all subjects involved in Clinical trials for the vaccine development candidates they oversee.

Matching Summary

The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.

Skills & Requirements

Must-have

  • Clinical development strategy
  • Protocol development
  • Regulatory authority interactions
  • Medical monitoring
  • GCP compliance
  • Data interpretation

Nice-to-have

  • Cross-cultural team leadership
  • Investigator network management
  • Public health agency engagement
  • Process improvement initiatives

Key Requirements

  • MD, PhD or PharmD minimum qualification
  • 3-5 years pharmaceutical industry experience
  • 5+ years academic clinical trial experience
  • English and Japanese fluency required

Work Rights

Not specified

Tailored Resume

Cover Letter