临床前药代总监/副总监Bio-analytical Science Director with focus on PK and Immunogenicity

面议

杭州市

刷新时间：2021-04-01

职位描述

JD of Bio-analytical Science Director with
focus on PK and Immunogenicity
Responsibilities:
1. Be an integral part of development team, drive projects forward with innovative bioanalytical approaches (PK modeling and ADA) that meet team goals.
2. Contribute to projects by conducting or interesting PK, PK analysis and
immunogenicity, so that studies are conducted at the correct dose range in China and
other countries. Interpret and communicate data to teams with an assessment of
impact on strategy, including proposals for issue resolution.
3. Work closely with project team to provide appropriate, effective and timely
responses to queries from NMPA and other Has.
4. Work with outsourcing team to provide expertise for large molecule PK and
immunogenicity evaluations interface with central lab and CROs, as required for
assigned projects.
5. Provide support for CRO selection, audits, monitor studies and review projects in the
context of bio-analytical related activities.
6. Support in-license due diligence effects and help identify opportunities derived from
these evaluations.
Qualifications:
1. Master and PhD degree in a relevant scientific field including PK, drug metabolism or
analytical sciences.
2. At least 5 years’ work experience in the pharmaceutical industry with focus on large
molecule PK, ADA related project support.
3. A clear understanding of large molecule metabolism, distribution, PK and
immunogenicity.
4. Must be able to conduct PK and ADA evaluations. The ability to use PK/PD modeling
will be a plus.
5. A good understanding of regulatory guidance relevant to PK and immunogenicity.
These include NMPA, FDA and EMA guidance.
6. Demonstrated experience and ability to work successfully as part of cross functional
teams in a highly dynamic, matrixed, project team environment
7. Excellent oral and written communication skills

其他要求

招聘人数：1人
职能类别：药物代谢

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。