上海招聘

• To propose safety and non-clinical strategies to support non-clinical development of drug candidates successfully IND/NDA filing.
• Define study requirements and coordinate appropriate non-GLP and GLP Tox in non-clinical project development in accordance with the Health Authorities requirement; contribute to the design of non-clinical study; identify potential project hurdles and suggest solutions.
• Contribute expert input into regulatory documents including investigator brochures, clinical study protocols and Development Safety Update Report within agreed timelines; Prepare, compile, and review appropriate sections of registration documents; represent Non-clinical in interactions with health authorities and external partners.
• To coordinate cross-functional effort in planning budgets, timelines and resource allocations.
• To monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams.
• To participate in and contribute to the feasibility assessment of proposed new projects and ventures during the project evaluation process. Performs other related duties as assigned.

• Master of pharmacology degree or above in biochemistry, biology, DMPK preferably pharmacology and toxicology, 5 years+ of experience in pharmaceutical industry
• Previous experience in new drug development
• In-depth knowledge of non-clinical toxicology (in vitro and in vivo), SOP, guidelines and GLP principles is must
• Fluent in oral English and effective communication
• Strategic thinking and good planning skills
• Performance driven
• Self-motivated and able to motivate the team

    江苏晨泰医药科技有限公司成立与2017年1月，是一家专注于研发创新疗法以满足医疗急需的临床研究阶段的公司。公司的管理团队在肿瘤治疗、临床运营、注册事务、医药营销等医学研究方面有几十年经验。目前在上海、北京设有办事处。
    2018年6月19日，晨泰医药科技有限公司（“晨泰医药”）宣布其成功完成A轮6,500万美元融资的首次交割，共计3,700万美元。这次融资由国内知名风险投资机构启明创投领投。其他几家知名的投资公司也参与了这一轮融资，其中包括泰福资本和醴泽健康产业投资基金。A轮募资将用于开展公司主要在研产品AZD3759的国际多中心II期临床试验，和进一步丰富公司的产品管线。
   为致力于全球化创新药物的临床开发。公司与国际大型制药公司合作, 确保产品的前期研发工作扎实可靠。利用公司强大的科学顾问和管理团队，制定最优化的创新药物开发策略，注重研发/市场/知识产权保护的多维布局。具体试验操作和业务开展方面与国际/国内顶尖的CRO/CMO/医院/研究院所合作，使用公司完善的项目管理体系来协调、监督项目合理有序开展。