Offers “Sanofi”

Expires soon Sanofi

Pasteur - Global Clinical Development Expert

  • Internship
  • Tokyo, JAPAN

Job description



Mission :

Reporting to the Regional Head of Clinical Development, the Global Clinical Development Expert (GCDE) will be a key member of the R&D project team and will represent the Clinical Development group within this team. Together with the R&D Project Leader, the GCDE will lead the clinical development component of the project(s) and manage the Clinical Development Plan in agreement with the project strategy in the country/the region/global in which he/she operates.
The GCDE works in close collaboration with the Trial Operations Lead and Management who are in charge of all operational aspect for clinical trial conduct.

The GCDE will be responsible for:
- Designing a clinical strategy plan in line with the overall strategy defined by R&D, the country(ies)/regional and the International Regulatory and marketing needs
- Gaining approval of this clinical-regulatory strategy plan from the relevant committees of sanofi pasteur

-Leading the local /regional/global clinical teams in the execution of the assigned clinical studies:
   - Leading the clinical team composed of various functions (monitoring, data management, biostatics, medical writing, Pharmaco-vigilance, -) and in charge of all operational aspects for the purpose of developing, implementing and executing the study. The GCDE leads the clinical team members, ensures adequate participation, contribution and accountability of the study team members and ensures adherence to the relevant SOP Processes.

   - Working in close collaboration with the Clinical Operations Managers for planning, assigning resources and controlling the budget by ensuring that this budget and resources appropriately meet the needs of the study, while maintaining cost controls.

-Ensuring that all clinical trial activities in the countries and/or the regions comply with the highest quality and ethical standards and that strict confidentiality is maintained
- Defining, in close collaboration with Pharmacovigilance, the safety surveillance process and risk management plan
- Leading the writing of clinical documents (protocols and reports) in line with the defined clinical-regulatory strategy

- Leading the interpretation and critical evaluation of study results and ensuring reporting of results from the clinical studies (including presenting results in scientific meetings or congresses)
- Participating in all registration activities including the preparation of clinical part for the Common Technical Document
- Building an effective network with internal and external teams (opinion leaders, investigators and relevant agencies).

Profile :

- MD preferred but a scientific background with PhD can be suitable.
- Experience of clinical research, in the Pharma industry, including design, management and implementation of international clinical development programmes
- Experience with vaccines, infectious diseases or related fields will be a plus
- Scientific and analytic skills

- Ability to develop a global approach
- Strong network ability
- Excellent presentation and communication skills
- Good organisational and project management skills
- Team leader, impact & influence
- Autonomy
- Team player, ability to work within a matrix organisation
- High levels of drive, initiative and commitment
- Fluent in written and oral English

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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