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重要环节，共同肩负着对候选药物、疫苗及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，共同培养清华大学“临床研究”与“监管科学”博士后。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及疫苗设计与研发能力，深入参与GSK在药物及疫苗的临床试验项目以及临床研究支持性功能的相关工作，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，公共卫生，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培养领域

·传染病、呼吸、肿瘤、免疫、疫苗领域的临床试验项目

·临床实验项目的运营、数据收集与管理、建模与模拟

1.4培养活动

·协助GSK临床科学家的新药及疫苗在研项目

·在GSK的不同部门进行轮转，了解新药及疫苗研发的整体流程

·学习药物动力学以及生物统计学等在临床评估中的应用方法

·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及疫苗研发中的重要性

·掌握临床数据分析的原理与方法

·熟悉药物及疫苗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的临床新药及疫苗项目提供监管科学支持。

2.2职位要求：

·获药学，医学，公共卫生，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：

·了解中国药品及疫苗审批指导原则与政策

·掌握药品及疫苗研发与评估的原理及应用

·熟悉药品及疫苗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

申请方式：

应聘者请将个人中英文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+硕博英才网，简历文件名称请包含姓名。申请截止日期2022年10月21日。

GSK-Tsinghua Postdoctoral Fellowship Program for Clinical Development and Regulatory Science

Tsinghua University School of Medicine, in collaboration with GlaxoSmithKline, is recruiting postdoctoral students to train for clinical development and research and regulatory science. The objectives and recruiting criteria are as following:

Track 1: Clinical Development and Research

Fellows will participate in GSK’s current clinical development studies and trials in the areas of respiratory, immunology, infectious disease and hepatology, oncology, and vaccine, and support operational functions, e.g., clinical Pharmacology Modelling & Simulation, data management, and operation and portfolio management. At the program, fellows will have hands-on training 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 and vaccine product development and evaluation; research design and methodology, including development of research protocols in the clinical investigation of new drugs and vaccines; and principles and applications of biostatistics, advanced pharmacokinetics, laboratory drug analysis, and study design methodology.

Requirements:

Doctorate in Pharmacy, Medicine, Public Health, or Science.

Professional proficiency in English and Chinese.

Meet the postdoctoral entry requirements of Tsinghua University.

Track 2: Regulatory Fellowship

The fellows will work with members of the GSK China Regulatory Affairs team and GSK’s Institute for Infectious diseases and public health to support ongoing clinical development portfolios under GSK China Development. This program aims to enhance the knowledge and provide real-world experience of the fellow that helps to cultivate professionals of regulatory science ready for working in the pharmaceutical industry or academia .

Selection Criteria:

Fellows will be selected based on their education background, relevant experience, and career goals as well as rules and regulations set forth by the Tsinghua University for postdoctoral fellows.

A post graduate degree in PharmD, MD, Public Health, or PhD.

Professional proficiency in English and Chinese are required.

How to apply:

Candidates are requested to send their resumes and related materials to zhangqi2013@mail.tsinghua.edu.cn.Please indicate in the subject of the email to apply for Tsinghua University "clinical research" and "regulatory science" postdoctoral program.

Application deadline: Oct 21, 2022.

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原文出处：

https://www.med.tsinghua.edu.cn/info/1374/4080.htm