工作职责:
主要职能：
Key Objectives/Deliverables：
1. 参与Pre-IND以及IND递交资料中临床相关部分的撰写与审核；
Participate in the development and review of clinical contents in pre-IND and IND submission materials.
2. 参与临床研究方案的专家研讨会议或其他形式的咨询活动，与研究者保持紧密沟通和联系；
Participate in the advisor board meeting or other means of activities for clinical study protocol consultation and keep close communication with investigators.
3. 调研相关治疗领域的研究文献，跟踪并总结所分配项目的竞争信息；
Perform literature research in relevant therapeutic area, follow up and summarize the competitive intelligence of assigned projects.
4. 协调、解决临床试验过程中的医学相关问题；
Coordinate and resolve medical related issues during the execution of clinical trials.
5. 在临床试验进行的过程中，提供持续的医学监查与审核，确保临床试验数据质量；
Provide continuous medical monitoring and review during the execution of clinical trials, and ensure the quality of clinical data.
6. 对研究相关人员进行研究方案、治疗领域等医学培训；
Provide medical training to project team members on clinical study protocol and therapeutic area knowledge.
7. 参与或支持文章发表、会议摘要、会议海报或其他公开发表刊物的医学撰写
Contribute to or support the medical writing of clinical trial relevant papers, conference abstracts, conference posters or other publications.
8. 与其他项目成员合作，推动项目关键交付成果。
Work with project team members to drive project key deliverables.
任职资格:
岗位要求：
Basic Requirements:
1. 临床医学、生命科学等相关专业，硕士以上学历；
Master’s degree or above in clinical medicine, life science or related majors.
2. 至少2年以上相关工作经验，熟悉并掌握ICH-GCP指导原则，熟悉药物研发流程；
At least 2 years related working experience, familiar with ICH-GCP guidelines, familiar with drug development process.
3. 具有早期临床开发经验者优先，有肿瘤治疗领域经验或熟悉肿瘤生物学更佳；
Experience in early clinical development is preferred, experience in oncology therapeutic area or good understanding of cancer biology is preferred.
4. 英语良好，能够熟练阅读英文文献，熟练操作办公软件；
Good Command of English, proficient in reading English literature, proficient in office software.
5. 有优秀的团队合作精神和沟通能力，有责任心，踏实认真。
Excellent teamwork spirit and communication skills, strong sense of responsibilities, and work in earnest
其他要求：
Additional Preferences:
自我激励，积极主动，愿意并能够在快节奏的环境中快速学习
Self-motivated, willing and able to learn quickly in a fast-paced environment