(ID60707)IND-Enabling Director (职位编号：60707)
上海任仕达人才服务有限公司
- 公司性质：合资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2017-08-02
- 工作地点：上海
- 招聘人数：1人
- 工作经验：2年经验
- 学历要求：博士
- 职位月薪：5-7万/月
- 职位类别：生物工程/生物制药
职位描述
职位描述：
Job Description:
? Work in a high motivated team and very dynamic environment, you will extend your potential to limitless. Position level will base on the individual experience and education background.
? Work with clients for preliminary studies selection and preliminary detailed study designs based on compound’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit.
? Scientific monitoring process of projects: RTPM will scientifically monitor all the process starting from lead optimization, pharmacology, DMPK (drug metabolism and pharmacokinetics), CMC, safety assessment (toxicology, pathology, analytical/bioanalytical), all the way through IND/CTA submission.
? Coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issues and input the constructive suggestions.
? With or without supervision, prepare the regulatory submission documents and dossier writing for analytical/bioanalytical, pharmacology, DMPK, or/and safety assessment parts. Search and prepare scientific references for project needs.
? Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development. Directly communicate (visiting host, holding TC and auditing, etc.) with national and international sponsors.
? Dynamic study results discussion and consultation: Based on the collected updating data/results, RTPM will continually tune up the studies and process during the progress of project for the best outcome.
Qualifications:
? Ph.D with 5 years and up or Master with 8 years and up relevant experience in in vitro /in vivo, CMC, or pharmacology, or DMPK, or safety pharmacology, or toxicology, or bioanalytical, experience on biologics will be plus
? Project manager experience (manage the preclinical program) must
? Biological science education background
? Experience in vitro or in vivo studies in research and drug discovery
? Regulatory background
? Regulatory writing experience will be a plus
? Excellent English and Chinese in verbal and writing
? Good interpersonal skill and teamwork spirit
? Accountability
? Capability to research and search information
? Potential for personal development within a short timeframe.
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Job Description:
? Work in a high motivated team and very dynamic environment, you will extend your potential to limitless. Position level will base on the individual experience and education background.
? Work with clients for preliminary studies selection and preliminary detailed study designs based on compound’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit.
? Scientific monitoring process of projects: RTPM will scientifically monitor all the process starting from lead optimization, pharmacology, DMPK (drug metabolism and pharmacokinetics), CMC, safety assessment (toxicology, pathology, analytical/bioanalytical), all the way through IND/CTA submission.
? Coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issues and input the constructive suggestions.
? With or without supervision, prepare the regulatory submission documents and dossier writing for analytical/bioanalytical, pharmacology, DMPK, or/and safety assessment parts. Search and prepare scientific references for project needs.
? Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development. Directly communicate (visiting host, holding TC and auditing, etc.) with national and international sponsors.
? Dynamic study results discussion and consultation: Based on the collected updating data/results, RTPM will continually tune up the studies and process during the progress of project for the best outcome.
Qualifications:
? Ph.D with 5 years and up or Master with 8 years and up relevant experience in in vitro /in vivo, CMC, or pharmacology, or DMPK, or safety pharmacology, or toxicology, or bioanalytical, experience on biologics will be plus
? Project manager experience (manage the preclinical program) must
? Biological science education background
? Experience in vitro or in vivo studies in research and drug discovery
? Regulatory background
? Regulatory writing experience will be a plus
? Excellent English and Chinese in verbal and writing
? Good interpersonal skill and teamwork spirit
? Accountability
? Capability to research and search information
? Potential for personal development within a short timeframe.
职能类别： 生物工程/生物制药
公司介绍
上海任仕达人才服务有限公司诚聘
联系方式
- Email：recruitmentsh@cn.randstad.com