医学总监

80-110万元/年

市辖区

刷新时间：2024-04-19

职位描述

  Responsibilities:
1. Manages the design and implementation of global clinical development programs (must include United States and China) in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements. Oversees project-related education of investigators, study site personnel, and study staff.
2. Has overall responsibility for oversight of clinical studies, medical monitoring, pharmacovigilance, overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
3. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
4. May oversee the work of Associate Medical and/or Clinical/Medical Scientists working on the same or related programs.
5. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
6. May serve on Clinical Strategy, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to asset development.
7. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with stakeholders in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
8. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
9. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
10. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.  

其他要求

招聘人数：1人
职能类别：医学总监

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。