Clinical Research Physician

Department
部门

Medical / Clinical Research, Research and Development
医学临床研发部,研发部

Title
职位

Clinical Research Physician
临床研究医生

Starting Date
任职时间

Direct Report
直线经理

Medical/Clinical Research Head

Direct Subordinates
直接下属
N/A
Primary Function
主要职能

The Clinical Research Physician is part of the project team for compound development, providing oversight and execution of clinical development program from clinical study design, protocol development, safety and efficacy data analysis and interpretation and clinical study report. This position will be located in Shanghai or Beijing, China.

临床研究医生作为药物开发项目团队,监督和执行临床开发项目各环节,包括临床研究设计,方案撰写,安全性和有效性的数据分析和阐释,以及临床研究报告。工作地点在上海或北京。

Major Responsibilities and Duties
主要职责和任务
  • To provide medical and scientific expertise to the design, planning, initiation and completion of clinical trials (from phase1 to phase 4 studies); and develop key documents (e.g. protocol, report, etc) in collaboration with cross-functional team.
  • To be responsible for communication of key clinical assumptions, risks and mitigation strategies by study/project.
  • To leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
  • To provide medical input into ongoing clinical studies:To perform medical monitoring for the projects; To manage and communicate with investigators; To support training and other scientific support for clinical operation and relevant third parties.
  • To provides input to publication strategy for the projects/products. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
  • To provide medical support to deliver regulatory submissions (IND and NDA, etc).
  • Relevant medical document preparation.
  • Communication with regulatory agency and relevant material preparation.
  • To provide medical and scientific input for other company business, e.g. business development.
  • 为临床实验(一期到四期)的设计,计划,启动和完成提供医学和科学专业意见,与其他部门合作撰写关键的临床试验文件(例如,临床试验方案,报告等)。
  • 在试验/项目层面,负责沟通关键临床假设,风险以及规避策略。
  • 领导或参与临床/医学咨询小组,咨询委员会和研究者会议。
  • 为正在进行的临床研究提供医学保障,包括:提供医学监督;管理并与研究者沟通;为临床操作和相关第三方提供培训和其他科学支持。
  • 为项目和产品的发布策略提供医学保障。可能会与学术研究者在科研会议上以及共同审阅的医学杂志上共同展示和发表临床研究结果。
  • 为向法规部门的申请提供医学支持(IND, NDA等)。
  • 相关医学文件的准备。
  • 与法规机构沟通并准备相关材料。
  • 为公司的其他商业活动如商业开发项目等提供医学和科学支持。
Qualifications
资格要求
  • With hospital physician experience to take care of patients.
  • Minimum master’s degree in clinical medicine or related bioscience.
  • Prior experience (2-5 years) working in the pharmaceutical and/or biotechnology industry with a superb track record of accomplishments.
  • Ability to provide an oversight on clinical design, generation of protocols, case record forms and clinical study reports.
  • Understanding of requirements for successful development, registration and commercialization of a new product.
  • Knowledgeable in drug development process and the competitive environment.
  • Strategic thinking, strong problem-solving skills for developing creative solutions and contingency plans and meeting project objectives.
  • Strong oral and written communications skills in both Chinese and English.
  • Presentation skill.
  • 具有医院医生经验,能够照顾病人。
  • 临床医学或其他相关生命科学硕士以上学历。
  • 在药企或生物技术公司有2-5年优秀工作经验。
  • 有能力监督临床试验设计,方案设计,病历记录表和临床研究报告。
  • 了解新产品成功开发,注册和商业化的要求。
  • 熟知药品开发流程和具有竞争性的环境。
  • 具有战略性思维和较强的解决问题的能力,能够制定创造性的解决方案和应急方案,并达成项目目标。
  • 优秀的中英文口头和书面表达能力。
  • 具有表达技巧。