u 工作职责：

1. 设计并撰写早期临床试验提案、方案和报告，尤其是临床药理学和生物标志物相关章节。

2. 参与项目重大决策，参与临床项目的制定和实施，以及法规相关文件的编写。

3. 负责临床药理学相关数据分析，包括PK和PK-PD分析。

4. 通过设计临床试验，促进投标过程。为临床研究方案和其他核心研究提供输入。

5. 审查非临床数据和指南，以确定首次人体研究的起始剂量。提供第1阶段研究中剂量递增和剂量范围的基本原理。

u 任职资格：

1. 药理学或相关领域的博士、硕士或硕士学位，至少2年药物发现和开发相关研究经验。

2. 在DMPK、生物学、药理学和临床研究方面有较强的背景。有药品研发经验者优先。

3. 熟悉CFDA法规和CDE新药注册审评要求。

4. 必须具备流利的英语口语和书面表达能力。擅长撰写临床试验方案和总结报告。

5. 强烈的动机、对细节的关注、独立思考的能力，以及充分融入高绩效团队环境的能力。

岗位职责:

1.Design and write early clinical trial proposal, protocol, and report, especially clinical pharmacology and biomarker related sections.

2.Participate in project major decision making, involve in clinical program development and implementation, as well as regulatory related document writing.

3.Responsible for clinical pharmacology related data analysis, including PK and PK-PD analysis.

4.Review and provide input into departmental SOPs.

5.Facilitate the bidding process with designing the clinical trial.

6.Provide input into clinical study protocols, and other core study.

7.Review nonclinical data and guidelines to determine the starting dose for first in human studies. Provides a rationale for dose escalation and dose range in phase 1 studies.

任职要求:

PhD, MD, or Master Degree in pharmacology or related field, with minimum of 2 years relevant research experience in drug discovery and development, preferably in a pharmaceutical setting.

Strong background in DMPK, biology, pharmacology and clinical research. Experience in Class I drug R&D is a plus.

Familiar with the CFDA regulations and CDE new drug evaluation requirements for registration.

Fluent in English, both oral and written, is a must. Good at writing clinical trial proposal and summary report.

Must be able to multi-task and participate effectively in teams.

Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment.

Read, write, and speak fluent English and Mandarin is required.