北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京生物工程/生物制药招聘

Clinical Pharmacologist Director(J10804)

南京金斯瑞生物科技有限公司

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2019-01-21
  • 工作地点:南京-江宁区
  • 招聘人数:1人
  • 工作经验:10年以上经验
  • 学历要求:硕士
  • 职位月薪:2-4万/月
  • 职位类别:生物工程/生物制药

职位描述

工作职责:

1. Contributes expert pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines

2. Develops PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection

3. Leads clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.

4. Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.

5. Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.

6. Serve on Global Clinical and Pre-Clinical Development Teams as Pharmacology representative and provides a source of Pharmacology expertise and advice to other functions across the Company

7. Coordinate with clinical and translational medicine teams on strategic priorities and study support

8. Performs other responsibilities as requested by management

9. Provide pharmacology expertise to due diligence activities as needed

任职资格

1. A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 3 years of experience in Clinical Pharmacology and/or pre-clinical PK is required

2. Experience with PK/PD, allometric scaling, analysis and translational modeling of preclinical PK/PD data, and mechanism-based PK/PD systems using preclinical and/ or clinical data with biologics therapeutics is also required

3. Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required

4. Proficiency of the application of a broad range of quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, R and other PK/PD analysis software.

5. Extensive experience and strong understanding of oncology drug development is preferred

o Flexible, with positive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company

6. Excellent written, verbal and interpersonal communication skills

7. Domestic and international travel will be required

公司介绍

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。

联系方式

  • 公司地址:科学园雍熙路28号
  • 电话:18075268323