Clinical Pharmacology and ADME
上海爱科百发生物医药技术有限公司
- 公司规模:50-150人
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-09-06
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:硕士
- 职位月薪:2.5-4万/月
- 职位类别:其他
职位描述
- Work closely with the clinical and the preclinical teams to create clinical pharmacology and preclinical ADME development programs providing a clear strategy towards the right dose to patients.
- Design, conduct, analyze, and interpret results from clinical Pharmacology and preclinical ADME studies to support decisions at study and project level.
- Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology and ADME results at the study level to support project at project team and governance level.
- Manage outsourced clinical pharmacology/ADME studies.
- Jointly accountable with the clinical and preclinical teams for providing a scientific justification for the dose selection for clinical and nonclinical studies.
- Participation in and accountable for peer review of ongoing activities, reports, and presentations of study results to internal and external forums.
- Contribute to regulatory documents and interactions (written and oral).
- Contribute to internal initiatives to develop the clinical pharmacology/ADME discipline including its processes
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s
- Master/Ph.D. in life sciences. Demonstrated broad translational development expertise and experience exemplified by at least 5-10 years of drug development experience, with emphasis on Clinical Pharmacology and/or ADMESkills/Abilities:
- Expert knowledge of pharmacokinetics
- Demonstrated ability to identify, develop, and execute clinical pharmacology/ADME activities at a project level
- Good oral and written communication skills
- Good knowledge of regulatory, compliance, processes, standards, and issues specific to clinical pharmacology/ADME
- Training and experience with PK software (Phoenix, WinNonlin)
职能类别:其他
公司介绍
爱科百发生物医药是一家专注于抗病毒创新药研究及开发的生物技术公司,致力于成为全球性的抗病毒创新药及儿科药研发生物技术公司,成立6年多以来已成立核心研发和管理团队,运营良好。公司总部坐落于中国药谷上海张江高科技园区,此外还在中国苏州、澳大利亚设立分公司。公司目前主要研发产品抗呼吸道合胞病毒(RSV)的新型药物已经完成临床II期试验阶段,并有望成为全球***个专门用于抗RSV病毒感染的临床药品,另有3个应用于流感病毒和乙肝治疗的产品处于研发阶段。
联系方式
- 公司地址:地址:span北京市丰台区新村街道航丰路时代财富天地