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毒理 manager
30-35K/月上海市-上海/硕士及以上/5-10年
符先生一周前来过
上海陛麟人力资源有限公司
职位详情
岗位职责
Ph.D in toxicology, pharmacology, or other related disciplines.
Diplomat of certified toxicologist by Chinese Society of Toxicology (中国毒理学会毒理学资格认证, or DCST), and diplomate American Board of Toxicology (DABT) preferrable
Familiarity with toxicology related guidance of major health authorities (CDE, FDA and EMA) and ICH
Knowledge of cell therapy, pharmacology, and DMPK
Working knowledge and experience with GLP studies including nonclinical safety toxicology, particularly in cell therapy
Responsibilities
Work with cell therapy project teams and clinical pharmacologist to design development strategies, covering toxicological aspects to enable clinical studies, which includes
Providing toxicology study strategy for investigator-initiated trials in China and for international Ph1 trials;
Supporting and/or instructing safety scientists on toxicology studies, providing oversights to toxicology studies by CROs; and
Sharing with pharmacologists/pharmacometricians and other team members mechanistic understanding of toxicology and clinical safety findings to support PK-PD data analysis work
Work with project teams to author the toxicology parts of regulatory submission dossiers (IND/NDA, etc.)
Share relevant external scientific papers with colleagues
Diplomat of certified toxicologist by Chinese Society of Toxicology (中国毒理学会毒理学资格认证, or DCST), and diplomate American Board of Toxicology (DABT) preferrable
Familiarity with toxicology related guidance of major health authorities (CDE, FDA and EMA) and ICH
Knowledge of cell therapy, pharmacology, and DMPK
Working knowledge and experience with GLP studies including nonclinical safety toxicology, particularly in cell therapy
Responsibilities
Work with cell therapy project teams and clinical pharmacologist to design development strategies, covering toxicological aspects to enable clinical studies, which includes
Providing toxicology study strategy for investigator-initiated trials in China and for international Ph1 trials;
Supporting and/or instructing safety scientists on toxicology studies, providing oversights to toxicology studies by CROs; and
Sharing with pharmacologists/pharmacometricians and other team members mechanistic understanding of toxicology and clinical safety findings to support PK-PD data analysis work
Work with project teams to author the toxicology parts of regulatory submission dossiers (IND/NDA, etc.)
Share relevant external scientific papers with colleagues
任职要求
无
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公司信息
上海陛麟人力资源有限公司
- 上海
- 100-499人
- 生物制药
- 民营
- 种子/天使轮
上海陛麟人力资源有限公司由招聘行业资深专家组成，致力于做精专行业中国领先的人力资源伙伴。陛麟的核心团队成员均拥有国际知名招聘顾问公司十年以上的人才甄选和招聘经验，在中高级别管理职位招聘实践中积累大量成功经验，是招聘市场上知名的行业专家。作为行业中坚力量，近年来陛麟为各类市场领导者和客户提供专业招聘服务。公司在医疗、消费品、零售等领域深耕多年，资源丰富；并在各关键职能部门，包括综合管理、销售和市场、供应链和人力资源等相关职能的招聘中得到客户的一致认可。
