1.领导临床开发。在整个开发过程中提供临床和医学专业知识,从临床开发计划、方案制定到临床研究实施、注册递交和产品上市
Lead clinical development. Provide clinical as well as general medical expertise throughout developments, from clinical development plan, protocol development through study conduct, regulatory submission(s) and product launch.
2.与合作伙伴的全球团队合作(如适用)为临床研究提供专家意见并监督方案制定
Provide expert input to the clinical studies and provide oversight of protocol development, in collaboration with partner’s global teams (if applicable)
3.负责临床方案以确定该地区的特定区域运营问题。必要时,对临床项目进行医学监督
Responsible for protocols to identify region-specific operational issues for the territory. Where necessary, provide medical oversight of clinical project
4.担任 CRO 合作伙伴的医学监督员或监督医疗质询和问题
Perform as medical monitor or oversight for CRO partners on medical queries and issues
5.在与监管机构的沟通中提供医学专业知识
Provide medical expertise in interactions with regulatory agencies
6.参加研究者会议;根据需要进行临床内容的介绍
Attend investigator meetings; deliver clinical presentations as needed
7.根据需要监督供应商,以确保临床研究成功实现注册递交目标
Oversight vendors as needed to ensure successful clinical studies for regulatory submission goal
8.积极确定该地区的关键研究者并维护长期合作关系。如果需要,建立和管理区域临床咨询委员会
Proactively identify key investigators in the region and cultivate long-term collaborations. Recruit and manage regional Clinical Advisory Board if needed
9.与外部科学专家、医学界建立并保持良好的合作
Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community