Medical Director 面议
  • 工作地点:南京
  • 工作经验:8年及以上
  • 招聘人数:1人
  • 学历:硕士及以上
  • 发布时间:2020-12-03
  • 有效时间:2021-04-30

职位描述:

岗位职责:

This position provides medical and scientific knowledge to guide and support the strategy and execution of the clinical development plan, works collaboratively with multi-functional team members responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted, including:

1. Work with the team to design, plan, and implement the clinical studies including development of study specific documents such as protocols and informed consents, regulatory documents as well as performing data review and analyzes and assisting with site visits and training activities;

2. Work closely with CRO and sites to ensure proper training and adherence to the protocol and study timelines;

3. Establish long term relationship with the KOLs and investigators;

4. Review enrolment package to ensure the patients meet study inclusion/exclusion criteria;

5. Work with PV team member to review and track emerging safety data, and take actions as appropriate;

6. Support PV team of regular review of individual subject safety data and review of cumulative safety data with the PV;

7. Write protocol amendments, as necessary, to address safety, efficacy, or operational issues in collaboration with Clinical Operations and regulatory team members;

8. Perform clinical database review, cleaning, query generation and analysis of study results;

9. Review protocol deviations (PD) and other study specific documents as needed;

10. Assist in preparation of clinical content of regulatory submissions / documents / meetings;

11. Assist with preparation of abstracts, posters, presentations, and publications;

12. Present clinical trial results internally and to the clinical sites;

13. Other duties assigned by the Company.


任职要求:

【Qualifications & Key Attributes】

1. Patient-focused, with deep commitment to understanding needs and improving the lives of patients and a passion for developing novel therapeutics;

2. Motivated to work in a fast-paced, high accountability, small company environment;

3. A "can do" and collegial professional who leads through influence and interpersonal skills;

4. Capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to details;

5. Strong Chinese-English bilingual written and oral communication skills, including presentation skills;

6. Ability to analyze and interpret data and develop written reports and presentations of those data;

7. Strong critical, strategic, and analytical thinking skills.

【Education & Experience Requirements】

1. Medical degree (Medical oncologist is a plus) with experience in clinical practice and 2-5 years of experience in the conduct of clinical trials in an industry setting (Pharma or CRO);

2. Experience in aspects of study conduct, including medical monitoring, data review and cleaning, protocol writing, start-up, study execution, analysis and reporting;

3. Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.

福利待遇:

1.足额缴纳五险一金;

2.周末双休、带薪年假、福利个假、法定节假日;

3.年终奖金、节日福利、高温福利、员工关怀福利;

4.交通补贴、午餐补贴、通讯补贴等;

5.年度体检、定期团建、年度旅游;

6.股权期权激励。


投递邮箱: hr@leadsbiolabs.com(标题格式:姓名+岗位名称)