南京招聘

Key Responsibilities

1. Responsible for the clinical safety monitoring and management plan, continued safety assessment, evaluation and risk management of Legend products in various stages of clinical development

2. Takes on activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimization; proposals for mitigation minimization measure; safety go-no go criteria for the clinical programme; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment

3. Provides medical input to ensure that risk-minimisation strategies are implemented appropriately in relevant documents such as ICF, IB, study protocol

4. Provides consistent communication of safety topics across all regulatory safety documents

5. Proactively evaluates the clinical implications of safety data from clinical studies, literature and other information sources in order to predict/ establish the safety profile of compounds in clinical development, including employing expert groups and methodologies, modelling and simulation to manage the risk to patients

 

Qualifications

1. Clinical Medical degree, professional designations/certifications/licenses

2. At least 3 years of clinical experience is required

3. Drug development experience and TA, drug safety knowledge is required

4. 2+ years industry experience relevant to PV or drug safety knowledge is preferred

5. Proactive and organized with solid habit of follow-up

6. Able to anticipate/ identify problems and takes appropriate action to correct and improve

7. High degree of accuracy with attention to details

8. Willing and able to learn quickly in a fast-paced environment

9. Excellent team player; express different viewpoints with colleagues in a proper and constructive manner

10.Excellent written and oral language skills in both Chinese Mandarin and English

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。