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、疫苗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（GSK）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2030”和世界人民的健康福祉做突出贡献。

本博士后项目时长为两年。两年期间，博士后可以根据自己的职业发展规划选择在临床研究与监管科学这两个方向之间轮转，或专注于其中一个方向。

博士后研究目标和遴选要求如下：

1. 方向一：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新药和疫苗临床试验流程以及临床支持部门（临床数据管理与建模，数据管理，临床运营）的工作，并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、公共卫生或相关领域理学博士学位

· 熟练掌握英语

· 符合清华大学博士后入站要求

1.3培养内容：

· 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，了解企业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新药及疫苗评估中的应用方法

· 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. 方向二：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的药品及疫苗监管部门以及中国研发团队的工作人员一起为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、公共卫生或相关领域理学博士学位

· 熟练掌握英语

· 符合清华大学博士后入站要求

2.3培养内容：

· 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

· 熟悉企业在药品及疫苗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

3. 方向三：人工智能/机器学习博士后项目

3.1 培养目标：近年来，随着人工智能技术的不断进步，其在药物研发领域的应用也变得越来越重要。人工智能可以帮助研究人员在药物开发的各个阶段提高效率和准确性，从而缩短药物研发周期，降低成本，将更有效的药物和疫苗尽早带给需要的人们。在这个项目中，博士后将于GSK中国研发部的专家一起，搭建训练模型，模拟训练，在实际操作探索各种人工智能和机器学习技术在药物和疫苗临床试验过程中的应用，了解如何使用这些技术来优化药物和疫苗的临床试验过程，并在试验的各个阶段提高效率和准确性。

3.2职位要求：

· 符合清华大学博士后入站要求

· 获统计，数学、计算机科学、生物信息学或相关定量领域的博士学位

· 至少精通一种编程语言，例如Python

· 熟练掌握英语

· 具有基于机器学习的开发和应用的方法的经验，至少一种深度学习框架（例如PyTorchTensorFlow或Keras）的经验

· 对人工智能在医疗制药应用感兴趣

Global integration poses unprecedented challenges to human health, and there is an urgent need to train and produce a new generation of leaders with international standards and comprehensive capabilities, to carry out innovative research, reform innovation systems and comprehensively enhance innovation capabilities in response to key bottlenecks. Innovation and development in the field of life medicine, clinical research and regulatory approval are two important links, shouldering the scientific assessment of the safety and importance of candidate drugs and medical devices, is a huge and complex system engineering, is the fundamental guarantee to promote the transformation of innovation results. To this end, Tsinghua University School of Medicine, in collaboration with GlaxoSmithKline, has trained postdoctoral students in "clinical research" and "regulatory science" at Tsinghua University. It is hoped that aspiring students will sign up, broaden their horizons, improve their abilities and display their talents, and make outstanding contributions to the health and well-being of "Healthy China" and the people of the world. The postdoctoral research objectives and selection requirements are as follows:

Track 1: Clinical Development 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 and Clinical support functions (Clinical Pharmacology Modelling & Simulation, Data Management and Clinical Operation) on clinical development programs of GSK assets. They will receive all necessary GSK trainings and assigned individual 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 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.

Track 2: Regulatory Science 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 and vaccine 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 collaborate with members of the GSK China Regulatory Department and GSK China Development staff 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.

Track 3: Artificial Intelligence/Machine Learning Fellowship

Overall Goal: In recent years, with the continuous advancement of artificial intelligence technology, its application in the field of drug development has become increasingly important. Artificial intelligence can help researchers improve efficiency and accuracy in various stages of drug development, thereby shortening the drug development cycle, reducing costs, and bringing more effective drugs and vaccines to people faster. In this project, postdoctoral researchers will work with experts from GSK China Development to explore the application of various artificial intelligence and machine learning technologies in the clinical trial process of new drugs and vaccines. They will learn how to use these technologies to optimize the clinical trial process of drugs and vaccines and improve efficiency and accuracy at each stage of the trial through practical operations.

The project is two years long and provides all the advantages of the Tsinghua University postdoctoral program. In addition, it provides researchers with an opportunity to work in a corporate environment and lay a solid foundation for their future career development. At the same time, they will have the opportunity to learn about the latest developments and trends in the pharmaceutical industry through working and studying at GSK.

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，简历文件名称请包含姓名。申请截止日期2023年5月15日。

How to apply:

Candidates are requested to send their resumes and related materials to zhangqi2013@mail.tsinghua.edu.cn . Please indicate the subject of the email to apply for Tsinghua University "clinical research" and "regulatory science" postdoctoral. Application deadline: 15.05.2023.