職位描述
Specific accountabilities:
- Designing a clinical strategy plan in line with the overall strategy defined by R&D, the country (China)/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(China) and/or the regional clinical teams in the execution of the assigned clinical studies:
- Leading the clinical team composed of various functions (e.g. study monitoring, data management, biostatics, medical writing, Pharmacovigilance among others) and in charge of all operational aspects for the purpose of developing, implementing and executing the study. The RDCD, when acting as CTL, 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 China and/the region 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).
- Designing a clinical strategy plan in line with the overall strategy defined by R&D, the country (China)/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(China) and/or the regional clinical teams in the execution of the assigned clinical studies:
- Leading the clinical team composed of various functions (e.g. study monitoring, data management, biostatics, medical writing, Pharmacovigilance among others) and in charge of all operational aspects for the purpose of developing, implementing and executing the study. The RDCD, when acting as CTL, 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 China and/the region 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).
職位要求：
Requirement:
- MD or equivalent degree as Doctor of medicine required.
- Experience of clinical research, in the Pharma industry, including design, management and implementation of international clinical development programs
- 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 organizational and project management skills
- Team leader, impact & influence
- Autonomy
- Team player, ability to work within a matrix organization
- High levels of drive, initiative and commitment
- Fluent in written and oral English and Chinese (Mandarin)
