北京招聘

职位描述：
毒理和药理临床前研究经理
岗位职责：负责公司的药物的药理、毒理和药效的临床前研究。Responsible for the oversight of the development of pre-clinical strategies of pharmacology & toxicology – from lead optimization to product approval of molecules in the development pipeline in a multi-disciplinary team environment. 具体的职责包括但不限于：
(1) Design and management of nonclinical studies and overall IND enabling program;
(2) Initiate and manage contracts, coordinate activities, and manage selected CROs for preclinical development in the areas of toxicology and pharmacokinetics;
(3) Provides preclinical expertise, strategy and work closely with other functional areas, particularly in DMPK, pharmacology and animal models;
(4) Critically review and edit CRO study reports, analyze and interpret data and coordinate report finalization;
(5) Communicate toxicology study findings to project teams;
(6) Prepare and edit non-clinical documents for regulatory submission (e.g. INDs, IB’s, and regulatory briefing documents);
(7) Maintain a current understanding of and ensure compliance with GLP, GMP, GCP and regulatory guidelines.
任职资格：
(1) Ph.D in pathology, pharmacology, physiology or related discipline; DABT preferred;
(2) Minimum of 5 years hands-on expertise in pharmaceutical toxicology/safety assessment and drug development;
(3) Experience with small molecules, participation on drug development and IND submissions;
(4) Experience in designing, monitoring and interpreting non-clinical safety studies;
(5) Excellent communication, collaboration and multi-tasking skills;
(6) Demonstrated proficiency in nonclinical study design and management;
(7) Mastery of preclinical drug development, strategy, practice and FDA regulations absolutely essential;
(8) Knowledge of CFDA regulations is a plus; 能够计划、组织实施和撰写相关申报材料 to CFDA;
(9) 具有出色的英文写作能力暨撰写英文科研总结报告的能力；良好的中文的听说读写能力;
(10) 具有出色的管理和协调能力;
(11) 具有高度的责任感、职业道德、敬业精神和契而不舍的工作精神。 举报 分享

   公司简介：
        安泰吉（北京）生物技术有限公司（简称“安泰吉公司”）是一家由曾在美国著名研究机构和生物制药公司从事生物新药研发的数位制药专家, 结合国内资本而创建的中外合作生物技术企业，位于北京市大兴新区亦庄开发区。安泰吉公司是集科研和开发为一体的现代生物技术企业，拥有国际前沿的生物医药技术、杰出的创新能力和意识。公司的营运目标是：（1）通过研发创新型高端生物制品（体外诊断试剂产品、单克隆抗体药物和肿瘤免疫治疗技术产品），供应国内外市场，缩短中国与美欧国家在制药领域的差距；（2）与其它公司合作，生产和销售生物制品。
公司的理念：
        通过卓越的生物医药技术研究开发，为消费者提供持久满意的创新型生物技术产品和服务；竭尽全力找出并满足消费者的需求；改善人类和动物的健康和生活质量；努力发展和保持企业在本领域的领先和主导地位，为股东和投资者提供优厚的回报；秉持最高的道德和诚信标准，为我们的消费者、员工及其家庭、投资者、我们所生存的环境、以及我们所服务的社会履行企业的责任；积极创造一种相互尊重、鼓励和团队合作的环境，使企业的杰出执行能力坚实地建筑在诚信、知识、想象力、技术、多样性和团队精神的基础之上。