主要职能：
Key Objectives/Deliverables：
1. 参与临床研究设计: 应用定量药理学知识，参与临床研究方案设计，包括剂量选择、采样时间点确定、研究人群选择等。
Participate in Clinical Study Design: Apply quantitative pharmacology knowledge to contribute to the design of clinical study protocols, including dose selection, sampling time point determination, and study population selection.
2. 数据分析和建模: 使用专业软件（如 NONMEM、R 等）对临床药理数据进行药代动力学 (PK)、药效动力学 (PD) 和 PK/PD 建模分析，识别影响药物疗效和安全性的关键因素。
Data Analysis and Modeling: Utilize specialized software (e.g., NONMEM, R) to perform pharmacokinetic (PK), pharmacodynamic (PD), and PK/PD modeling and analysis on clinical pharmacology data to identify key factors influencing drug efficacy and safety.
3. 模拟和预测: 基于建立的模型，进行模拟和预测，评估不同剂量方案、给药途径、患者人群等因素对药物疗效和安全性的影响，为临床试验设计和决策提供科学依据。
Simulation and Prediction: Conduct simulations and predictions based on established models to evaluate the impact of various factors, such as dosing regimens, routes of administration, and patient populations, on drug efficacy and safety. Provide scientific rationale for clinical trial design and decision-making.
4. 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;
5. 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;
6. 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;
7. 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. 硕士及以上，药代动力学、临床药理学及定量药理相关专业，2-3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，可以接受应届毕业生。
MS in pharmacokinetics, clinical pharmacology or related disciplines with 2-3 years training/working experience; 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，NLME等;
6. 具备良好的编程能力（如 R、Python 等）
Proficient in programming languages such as R, Python, etc.
7. 良好的英文读写能力。
Good skills in English literacy.