毒理总监
60-100万元/年
佛山市
刷新时间:2小时前
职位描述
Primary Responsibilities
• Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials
• Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals
• Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)
• Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables
• Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards
• Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities • Serve as a subject matter expert to provide input for due diligence of potential external partnership programs
Qualifications
• 15+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting
• Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting
• Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred
• Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies
• Excellent communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts
Education
• Ph.D. or equivalent in Toxicology or closely related field
• Toxicology board certification is a plus
其他要求
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1人
- 药理/毒理/药效
公司介绍
诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。