国际临床VP/Vice President of International Clinical Dep.

面议

海外国家博士及以上

刷新时间：2021-04-27

职位描述

工作职责
• Responsible for Strategy development, create a strategic map of relevant clinical study evidence by products;
• Responsible for development of clinical protocols to support the company’s product drug candidates, strategy, data collection and management and final reports development in compliance with appropriate standard operating procedures, regulatory and good clinical practice standards
• Responsible for clinical trial execution including, data analysis and reporting to prepare documentation required for regulatory and legislative drug approvals
• Ensure adherence to industry standards of Good Clinical Practice
• Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Engage thought leaders, investigators, cooperative groups and other experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
• Manage the preparation and/or review of data listings, summary tables, study results, study reports, and regulatory documents, IND annual reports, IND safety reports, investigator brochures, and clinical development plans
• Coordinate the collection and analysis of clinical data, develop manuscripts for publication in peer-reviewed journals and prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert clinical advisory meetings
• Work collaboratively to evaluate business development opportunities
• Ability to travel domestically and internationally to company, scientific, investigator, and other meetings

工作要求
• An MD with board experience in CNS, Oncology, Cardiovascular or mentalism;
• Minimum of 10 years of relevant experience in drug development of small molecules, antibodies, cancer vaccines in pharmaceutical or biotechnology company
• A proven success record in oncology and CNS clinical research studies and trial design as well as the successful submission of IND’s.
• Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines
• Strong scientific background in oncology and immunology
• Experience in translational medicine, clinical pharmacology, and biostatistics

其他要求

招聘人数：1人
职能类别：临床项目经理PM

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。