北京招聘

Key Responsibilities

1. As the Medical Lead for China-focused clinical trials, provides clinical leadership, medical and scientific strategic input, and contributes to the development of trial related documents (e.g., Clinical Trial Protocol, informed consent form, case report forms, data monitoring committee charters, data analysis plan, clinical study reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for local medical organization

2. In collaboration with integrated Clinical Trial Team (iCTT) members

· Ensures direct medical support of trials as needed and may act as medical monitor

· Conducts ongoing medical and scientific review of clinical trial data

· Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT)

· Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external

presentations

3. Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post- marketing surveillance

4. Provides medical and scientific input and contributes to clinical sections of program level regulatory documents (e.g. Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)

5. Supports CDD or CD VP with contributing to peer-review of IDPs, CTPs, and other clinical documents, as needed

6. Supports development of the disease area strategy for China

7. Leads or serves on China work streams to improve clinical development process, acts as Subject Matter Experts for standard operating procedures or trainings, and/or contribute to other cross-functional or Clinical Development line function initiatives

8. Responsible of medical/scientific training for relevant LG stakeholders on the disease area and compound/molecule

9. Contributes to talent and career development of China CD associates through on- boarding, coaching, and/or mentoring support; and may contribute to the performance evaluation of China clinical trial team members

10. Contributes to China initiatives (e.g. process improvement, training, local SOP development, other development unit line function initiatives)

11. Acts as Clinical Development Physician (CDP) in China when required

12. Takes on special task assigned by the line manager

Qualifications:

1. Medical Degree required, >3 years Clinical experience preferred
2. Excellent verbal and written communication skill in Chinese and English
3. >5 years drug development experience
4. Advanced disease knowledge is preferred with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
5. Strategic thinking by actively seeking information to develop optimal clinical development strategy for registration
6. Demonstrated ability to establish effective working relationship with key investigators
7. Working knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, and regulatory and clinical development processes
8. Strong interest/experience in coaching less- experienced associates and/or be able to function effectively as a medical leader in a cross functional team
9. Strong learning agility，Strong interpersonal skills，Strong negotiation and conflict resolution skills
10. Proven ability to work independently in a cross functional team setting

金斯瑞生物科技股份有限公司（股票代码HK01548）是全球化的生物科技集团公司。集团植根于领先的基因合成技术，核心业务范围已涵盖生物药开发与生产CDMO业务、细胞与基因治疗、生命科学服务及产品、生物酶及合成生物学产品四大领域。

金斯瑞成立于2002年，并于2015年在港交所主板挂牌上市。集团总部位于中国南京，运营实体遍布大中华区、北美区、欧洲区及亚太区，并以此为依托，为全球160多个国家和地区的10多万客户提供优质、便捷、可靠的服务与产品。

目前，金斯瑞在全球拥有超过3000名员工，其中34%以上的员工拥有硕士或博士学位。金斯瑞拥有多项知识产权及技术机密，其中包含100多项授权专利及270多项专利申请。截至2019年6月30日，有超过40,300篇经国际同业审阅的学术期刊文献引述了金斯瑞的服务及产品。

秉承“用生物技术使人和自然更健康”的企业使命，金斯瑞将一如既往地致力于成为最受信赖的生物科技公司。