临床前研究总监/副总监（毒理/PK）

面议

广州市

刷新时间：2024-01-25

职位描述

Summary
This position is to be in charge of preclinical toxicology/safety studies and representation for preclinical team from PCC confirmation and IND submission to NDA application. The position will report to the R&D Head.
该职位负责临床前毒理学/安全研究，并代表临床前团队全程参与从PCC确认、IND提交直至NDA 申请。该职位将直接向研发负责人进行汇报。


Job Description 岗位职责：
•Serve as Preclinical Safety Representative for multiple programs of innovative drugs (mainly large molecules), contribute to the program’s goals and deliverables, and move the programs forward.
负责公司创新药物(主要为大分子药物)管线的临床前安全性研究，推动项目进展。
•Design all types of toxicology studies required to confirm PCC and prepare IND filing in China and other countries/areas and support clinical development of large molecules; review and approve study reports.
设计在中国和其他国家/地区进行PCC确认和IND申请所需的各类毒理学研究方案，为大分子药物 的临床开发提供支持; 审核和批准临床前研究报告。
•Ensure that the preclinical safety plan is aligned with the clinical development plan, and in compliance of GLP regulations and study guidelines (e.g. NMPA, FDA, OECD, ICH etc.)
确保临床前安全计划与临床开发计划协同，且符合GLP法规和指南(如NMPA、FDA、OECD、ICH 等)。
•Be able to supervise PK tasks performed at CROs. 有能力监管由CRO执行的PK任务。
•Serve as tox/safety expert to provide input on other programs/studies and evaluate the projects from potential external partners to identify in-license opportunities.
作为毒理/安全专家，为其他项目/研究提供意见，评估潜在的外部合作项目，以确定获得许可的 机会。
•Collaborate with other function groups internally or externally (project management, clinical, regulatory, pharmacology, translational medicine, CMC, etc.) on program/project tasks and

objectives.
与内部或外部其他职能部门(项目管理、临床、法规、药理学、转化医学、CMC等)协作达成项目 目标。
•Ensure the preparation of regulatory documents for IND and NDA in high quality and support regulatory submissions and clinical development.
制备高质量的IND和NDA申报文件，支持申报注册文件的提交和临床开发工作。

Qualifications 任职资格
•In-depth theoretical knowledge in toxicology/safety, and strong problem-solving skills in tox field. 深刻的毒理学/安全专业知识和解决问题的能力。
•Ph.D. with 5+ years or M.S. with 8+years working experiences in tox/safety area in biotech, big pharma or CRO.
博士学历5年以上或硕士学历8年以上在生物制药企业、大型药企或CRO的毒理/安全领域工作经 验。
•Rich experience in both GLP and non-GLP compliant in vitro and in vivo toxicology study conduct and reporting.
丰富的GLP合规和non-GLP体外和体内毒理学研究和报告撰写经验。
•Be familiar with applicable GLP regulations and study guidelines (e.g. NMPA, FDA, OECD, ICH etc.) and the interaction with regulatory agency.
熟悉GLP法规和研究指南(如NMPA, FDA, OECD, ICH等)以及与监管机构的互动。
•Project management skills with the ability to interact effectively with CRO and internal/external experts for the design, execution of safety studies.
具备项目管理技能，能够高效地与CRO和内部/外部专家共同设计、执行安全性实验。
•Good communication and technical writing skills in both Chinese and English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
优秀的中英文沟通和写作能力，能与科学家团体、高级管理人员和外部科学专家自如交流。

其他要求

招聘人数：1人
所属部门：临床部门
职能类别：临床总监

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。