全球一体化对人类健康提出了前所未有的挑战，迫切需要培养和造就具国际水平和综合能力的新一代领军人才,针对关键的瓶颈问题，开展创新研究、改革创新体制，全面提升创新能力。生命医学领域的创新发展，临床研究和监管审批是两大重要环节，共同肩负着对候选药物和医疗器械安全性和有效性的科学评估，是庞大和复杂的系统工程，是推动创新成果转化的根本保障。为此，清华大学医学院与葛兰素史克合作，共同创建清华大学”临床研究”与”监管科学”博士后流动站。希望有志的学生们踊跃报名，开拓视野，提高能力，展示才华，为“健康中国”和世界人民的健康福祉做突出贡献。 博士后研究目标和遴选要求如下：

1.     临床研究博士后项目

1.1  培养目标：临床研究博士后项目着重培养医学毕业生的新药设计与研发能力，深入参与GSK的药品临床试验流程，熟练掌握药物分析中生物统计学的应用，药代动力学评估的原理及方法等。

1.2  职位要求：

·          获药学，医学，或理学博士学位

·          熟练掌握英语

·          符合清华大学博士后入站要求

1.3  培养活动：

·          协助GSK临床科学家的新药在研项目

·          在GSK的不同部门进行轮转，了解新药研发的整体流程

·          学习药物动力学以及生物统计学等在新药评估中的应用方法

·          丰富的学术讨论与交流活动

1.4  培养目标：

·          了解临床研究在新药研发中的重要性

·          掌握临床数据分析的原理与方法

·          熟悉药物分析的先进技术与局限性

·          理解特殊群体临床试验中应设计的要素

·          完成项目总结报告

2.     监管科学博士后项目

2.1  培养目标：监管科学博士后将与GSK的药品监管部门以及传染病与公共健康研究中心的工作人员一起为GSK的临床新药项目提供监管科学支持。

2.2  职位要求：

·          获药学，医学，或理学博士学位

·          熟练掌握英语

·          符合清华大学博士后入站要求

2.3  培养活动：

·          了解中国药品审批指导原则与政策

·    & nbsp;     掌握药品研发与评估的原理及应用

·          熟悉药品IND，NDA申请的要求与方法

·          研究监管政策的发展，应用，以及指导原则的解析

Track 1: Clinical Fellowship

Overall Goal:  

The Clinical Development Fellowship program is a post graduate research program with a strong emphasis on training and developing the successful Tsinghua medical school graduates who are selected to participate. The Fellows will assist GSK clinical scientists on clinical development programs of GSK compounds. They will receive all necessary GSK trainings and be assigned inpidual projects under the close supervision of GSK staff.  The overall objective of the program is to provide post-graduate practical training or equivalent in the principles and applications of pharmaceutical product development and eva luation; research design and methodology, including development of research protocols in the clinical investigation of new drugs; and principles and applications of biostatistics, advanced pharmacokinetics, laboratory drug analysis, and study design methodology.

Track 2: Regulatory Fellowship

Track 2: Regulatory Fellowship

Overall Goal: 

The goal of this fellowship is to provide on-the-job practical training and experience in key regulatory functions in order to gain expertise in the regulatory requirements of drug development.  The fellowship program is a post-graduate training program with a strong emphasis on attracting talents and developing successful Tsinghua candidates who are selected to participate. The Fellows will work with members of the GSK China Regulatory Department and GSK’s Institute for Infectious diseases and public health (IIDPH) to provide regulatory support for clinical development and other GSK programs. Overall this program should enhance the knowledge and real world experience of the fellow and develop a regulatory practitioner prepared for the pharmaceutical industry or academia once the fellowship is completed.

Criteria for selection of Fellows:

 Fellows will be selected based on education, relevant experience, and career objectives, as well as rules and regulations set forth by the Tsinghua University for postdoctoral fellows.  A post graduate degree in PharmD, MD or PhD and Fluency in English are required.

申请方式：

应聘者请将个人简历及相关材料发送至zhangqi2013@mail.tsinghua.edu.cn。邮件主题请注明应聘清华大学”临床研究”与”监管科学”博士后。申请截止日期2017年6月15日。

来源：

http://www.med.tsinghua.edu.cn/SingleServlet?newsId=627