Toxicology Head

面议

佛山市

刷新时间：2024-04-09

职位描述

Toxicology Hea*******>Primary Responsibilities

• Provide preclinical safety expertise and strategy for pre-clinical and clinical development program***rom 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

• Ens**e 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; ens**e they are using systems and processes in compliance with all relevant regulatory standards

• Write and review document***or 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 d******** of potential external partnership programs

Qualifications

• 10+ 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 preferre********>• Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external expert***or the conduct of toxicology studies

• Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientif****xperts

其他要求

招聘人数：1人
职能类别：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。