职位描述:

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.

任职条件:

1. 硕士，药代动力学、临床药理学及相关专业，4-5年以上临床药理相关工作经验，有I类新药研发经验者优先；

MS in pharmacokinetics, clinical pharmacology or related disciplines with 4-5 years training/working experience;

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.