职责范围Scope of responsibility

负责临床研发阶段与医学相关的研究方案设计、执行、监查、分析和报告，并且负责研发策略制定.

To be responsible for the medical related work in different stages of clinical trials, include study design, protocol writing, execution, medical monitoring, study report. Be responsible to develop the clinical development plan

工作职责Responsibility

1. 确保医学相关工作的执行，包括但不限于如下任务：

Ensure the deliveries of medical related jobs, include but not limited to:

2. 制定产品开发策略。

Develop the clinical develop plan.

3. 设计及撰写研究方案及其他IND/NDA需要递交的医学相关的文件等。

Study design, prepare study protocol and other IND/NDA medical related documents

4. 在研究过程中担任研究医师并履行相应的职责，包括对研究方案进行培训，撰写医学监察计划，SMC charter,审核ICF, CRF, SAP等研究相关文件，进行医学监察，撰写审核及批准研究报告，审核SAR等。

To work as the clinical physician in the study include deliver protocol training, develop medical monitoring plan, SMC charter, review ICF, CRF, SAP etc. study related documents, do the medical monitoring, prepare the study report, review and approve SAR etc.

5. 保证良好的沟通，负责对申办方及药物监管部门针对医学研究提出的问题做出及时准确回应。支持CDE答辩会等。

Keep the good communication with different stakeholders; be responsible to reply the questions from the sponsor and authority. To support the CDE meeting if needed.

6. 保证良好的与研究者的沟通，必要时召开医学咨询会，确保方案设计的科学性及研究数据解读，研究报告的科学性。

Keep good communication with the investigators; organize the consultation meeting, to ensure the scientific of study design, data interpretation and report etc.

7. 支持医学相关的稽查和视察活动。

Support medical related audit and inspection activities.

8. 建立及完善医学相应的SOP及流程，以保证政策和法规的依从性。

Set up and perfect the medical related SOP to ensure the regulation compliance.

9. 参加及支持业务开发活动（BD activity），提供医学相关的支持， 在外部会议进行医学相关的发言等。

Join and support BD activities, to give the medical related support, to give the medical related presentations in the external meetings.

10 维护良好的跨部门合作及外部客户(包括申办方，研究者及CFDA官员等)关系。

Maintain good cross function and external customer relationship. (include but not limit to the sponsor, investigators and CFDA officers)etc.

任职资格 Qualification

• 临床医学专业本科/硕士/博士 (博士，有临床经验者优先)和2 以上年制药公司或CRO 相关的临床试验医学支持经验。

Bachelor and above, clinical medicine (PHD, clinical doctor experience are priorities), >=2 years pharma or CRO experience.

2. 具有良好的GCP, 临床试验法规相关知识, 具有临床方案设计及药物开发计划设计的经验。

Good GCP knowledge, good clinical trial related knowledge, experience of study design and drug development plan.

3. 良好的临床试验试验方案撰写，临床研究报告撰写，医学监察计划设计及执行经验。

Good experience of writing study protocol, report, medical monitoring plan etc. Good execution experience.

4. 良好的相关疾病治疗邻域的经验。

Good therapeutic area knowledge.

5. 英语和普通话流利，书面和口头。

Fluent English and Chinese, both written and oral.

6. 良好的人际能力，能和各级组织进行专业的沟通。

Good interpersonal skill can have professional communication with all levels of the organizations.

7. 独立工作的能力，并且具有团队精神。

Can work independently as well as a good team player.

8. 具有在跨部门的工作中的领导力, 适应快节奏的工作。

Demonstrate the leadership in the cross function work and can adjust to the fast speed work

9. 能够同时处理多项任务，高效按时完成工作。

Can be multitasked and can complete the work efficiently.

10. 良好的解决问题的能力。

Good problem solving capability.

上班地址：黄陂南路（地址1号线新天地站，9、10、13号线马当路站）