岗位名称(Title)
临床医学负责人-Clinical Science Leader 所在部门:(Department) 临床研发 职务编号： Position No. 配置人数： 4人
Headcount:
组织关系
Related positions in organization 直接上级 Line Superior----首席医学官
下属管理 Subordinate----待定
To Be Determined
职责范围
Scope of responsibility Be responsible for the design, implementation, monitoring, analysis, and reporting of domestic and international studies conducted in the early and late development stage with the medical contributions to the activities throughout the process from Investigational New Drug to New Drug Application as well as line extension based on the product lifecycle strategy among molecules in oncology area

工作职责
Responsibility A.Accountable for the domestic and international clinical development strategy with corresponding molecule(s) in oncology area from clinical perspective：1）Prepare clinical documents required from different health authority with effective inter****；2）Design clinical development plan and study protocol；3）Monitor and review medical data for clinical trials；4）Analyze, present, and interpret the data from ongoing and/or published studies；5）Collaborate actively with cross function teams, such as drug safety, regulatory, clinical operation ,data management, statistical analysis etc.；6）Publish data in domestic and/or international academic platform with abstract, ****, presentation etc.
B.****uate opportunities and plan on approved molecules for the development of new indications
C.Participate and support strategic planning and implementation for the disease area among oncology area
D.Participate and support the research, in/out licensing of new targets or drugs in oncology area led by business development and/or preclinical research team
E.Interact with external experts from healthcare organization and/or institutions in oncology area (e.g., Center of Drug ****uation, Advisory Committee, Key Opinion Lead)
F.Holding CRO/Partners accountable for the high quality standards of their deliverables
绩效标准
Criteria of performance 参照公司绩效管理制度执行。

任职资格
Qualification 基本
条件Basic A.Certificates as clinical doctor with practice experience in oncology area
B.At least 3-year experience of clinical drug development in pharmaceuticals/biotech industry, including designing and implementation of clinical projects in early/late stage, or more than 5 years clinical experience with specific therapeutic area
C.Experience of preparation and implementation for clinical trial application and/or new drug application
D.Ability to drive the delivery of commitment in a matrix team
E.Good written and oral communication skill in both Chinese and English in the negotiation, presentation, and authoring process with relevant cross function team, medical experts, as well as regulatory reviewers
F.Sufficient knowledge of business process, regulatory, and compliance related to drug development
G.Competency on good decision making, influencing, and execution in the changing business environment and being comfortable for uncertainties through excellent risk management skill

香港H股上市公司，年销售额60亿。总部在山东，按照国际标准在上海张江设立了研发中心。