PreclinicalResearchDirector

面议

浙江省

刷新时间：2022-11-22

职位描述

诚招一名具有临床前丰富研发经验的副总裁，全面负责异种器官移植的临床研究和合作协调
工作。该岗位直接向 CEO 汇报工作。
岗位职责
岗位要求
1. 全面负责临床前实验工作。
（1） 负责设计临床前实验方案，确保实验方案的科学有效性，并负责临床前开发标准、规
程和指南的撰写；
（2） 根据公司整体战略计划，制定合理的临床前工作计划；
（3） 管理实施过程，确保实验过程严格按照要求在时间节点内有效进行；
（4） 督导执行实验记录，保证实验有迹可循；
（5） 总结数据，审阅并撰写研究报告。
2. 在公司内部及其相关部门中**、提出、讨论并带领解决出现的问题。
3. **与合作单位进行的临床前研究的科学性和技术性问题，与外部合作单位建立和发展合作
关系。
4. 负责公司 IND enabling study 的推行；
5. 协助就异种移植问题与 CFDA and FDA 监管机构沟通；
6. 协助跨组织、跨职能工作，包括监管部门、研究团队及其他团队。
7. 出席并参加学术会议，协助撰写相关文章。
1. 生物、医学、动物相关领域博士;
2. 有 IND enabling study 和 细胞和基因治疗经验的经验；
3. 具有较高的科研素养，有独立发现问题，解决问题的能力，能独立设计实验、协调和组织
临床前实验。
4. 具有综合、组织和分析多学科数据的能力以及优秀的科学写作和编辑能力以及书面/口头沟
通能力，能协调、组织、分析和撰写相关报告和文章。
5. 具有科研团队管理经验，在目标导向的环境中与多学科团队，外部合作伙伴推进合作。
6. 有全流程药物研发经验，有药理学/毒理学或临床前相关科学博士后经验者优先。
7. 有 NHP、猪等大动物学科知识或经验者优先。
8. 具有临床前开发相关法律、法规知识和经验者优先。
9. 具有免疫学相关经验优先。
10. 了解 FDA 和 CFDA 对异种移植临床转化的要求优先。
11. 良好的英语沟通能力。

 ROLE OVERVIEW:
This is a unique opportunity to be a major contributor to the success of a well-positioned growth stage company, which requires he/she to architect the scientific and development strategy and oversee execution for all of its programs. This position reports to CEO.
KEY RESPONSIBILITIES: 

·Construct and execute a robust, resource-efficient scientific program strategy with strategic mindset. 

·Make specific implementation plans, organize, supervise and evaluate projects
·Efficiently and professionally respond to inquiries on Early Research and lead to solve problems 

·Responsible for organizing various business and technical meetings with advisors, collaborators and regulatory authorities 

·Lead Early Research management and team building, be responsible for staff training, performance assessment, lab management, budget and cost control 

·Establish and expand cooperation with external advisors 

·Support IND declaration and intellectual property declaration 

·Hire and lead teams, ensure they are properly mentored, trained and motivated 

·Provide feasible solutions to the problems and challenges encountered in the projects, and guide team members to write project reports, patents, fund applications and scientific research papers.

 MINIMUM QUALIFICATIONS OR EXPERIENCE NEEDED: 

·Ph.D. with 5+ years’ experience required with strong record of scientific accomplishment, visibility and involvement in biology/medical community 

·Rich industry R&D management and biopharma experience is required, experience in large pharmaceutical enterprises or foreign companies will be given preference 

·Proven track record of delivery of key milestones from inception to clinical studies and the ability to contribute at a technical level to multiple programs simultaneously 

·Rich experimental basis in molecular and cell biology, experience in editing animal cell lines or experimental animal genes 

·Familiar with whole process and national policies/regulations of drug R&D, understand the contents and procedures of pre-clinical application 

·Creative scientist who can work closely at the interface of biology with preclinical development to facilitate the development of new products that can benefit a broad range of health conditions with strong executive capability and strong desire for knowledge
·Organizational aptitude to build, lead and develop an outstanding team 

·Strong interpersonal skills, a collaborative working style, a strong track record of mentorship of research staff, and an enthusiasm for building partnerships among key collaborators 

·Extraordinary insight into new technologies and products in the industry, provide reasonable suggestions to the management on R&D 

·Adaptability, flexibility, independence and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment Strong career pursuit and career ideal, seek long-term development and common growth 

·Strong operational mindset, decisive, "get it done" mentality. Ability to work in a fast-paced, high growth environment where handling pressure and achieving deadlines are normal 

·Excellent communication skills (verbal, written and presentation) with the ability to synthesize and explain complex technology terms.

其他要求

招聘人数：1人
职能类别：研发科学家/领军人才

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。