主要职能：
Key Objectives/Deliverables：
1. 根据临床前、临床相关文献的总结分析，为临床试验临床药理学提供合理设计；
Responsible for reasonable design of clinical pharmacology study according to the summary of preclinical and clinical information.
2. 进行临床药理学研发策略的制定及更新；
Designing and updating the research and development strategy for clinical pharmacology.
3. 负责临床药理相关的方案设计、数据分析，与其他相关职能部门沟通，协助综合分析新药PK/PD/安全性相关性；
Responsible for protocol design, data analysis in clinical pharmacology study, and keep good communications with other functions to explore the PK\PD\safety correlation.
4. 临床试验中药代动力学研究方案和报告的撰写和审阅，及NDA申报资料中临床药理学部分的撰写和审阅；
Writing and reviewing the study plan and reports, and the NDA application documents in clinical pharmacology section.
5. 临床药代动力学研究的项目管理，与CRO进行有效沟通，确保临床试验中药代动力学研究的顺利进行。
Responsible for project management of clinical pharmacology and keep good communications with CRO to ensure the project processing fluently.

岗位要求：
Basic Requirements:
1. 硕士，药代动力学、临床药理学及相关专业，有I类新药研发经验者优先，可以接受应届毕业生
MS in pharmacokinetics, clinical pharmacology, experience in 1.1 new drug development is preferred. Fresh graduate can be accepted.
2. 熟练掌握药物代谢动力学基本原理；
Familiar with the basic principle of pharmacokinetics.
3. 熟悉生物样本分析方法开发和建立的要求；
Familiar with the analytical method development and validation for biological samples.
4. 熟悉药物临床研究内容；
Familiar with the clinical trials and related guidelines in clinical study development;
5. 熟悉药动学软件，如DAS/WINNONLIN等。
Good practice in the use of PK software, such as DAS/WINNONLIN.
6. 良好的英文读写能力。
Good skills in English literacy.