Clinical VP

面议

成都市

刷新时间：2021-04-27

职位描述

Position Summary:
The primary role of the VP will be to provide leadership and direction for pipeline of clinical development programs in both cancer and metabolic disorders. The VP will be responsible for the strategy, direction and execution of the company’s clinical development plans. The VP will be a key member of the senior management team which determines and oversees research and drug development and sets the overall strategic direction of the company.
职位摘要：
VP的主要作用是在癌症和代谢紊乱中的临床开发项目提供领导和指导。VP将负责公司临床发展计划的战略、方向和执行。VP将是管理和监督研究和药物开发的高级管理团队的关键成员，并为公司制定总体战略方向。
Essential Duties and Responsibilities:
Direct the development of clinical strategies;
Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities;
Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results;
Lead interactions with KOL, investigators, cooperative groups, and other clinical stakeholders;
Represent the company and its programs to external audiences,including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners;
Has responsibility for the clinical operations, patient advocacy, medical affairs, and biostatistics;
Gradually build up a functional clinical research team within the company.
基本职责：
指导临床策略的发展；
协调和管理与卫生当局相关的监管策略和互动的临床方面；
监督临床试验数据的分析和解释和临床试验结果的报告；
领导与KOL、调查员、合作小组和其他临床利益相关者的互动；
代表公司和它的节目给外部观众，包括投资、医疗和监管社区，以及制药或生物技术产业的合作者/合作伙伴；
负责临床操作、病人宣传、医疗事务和生物统计；
③逐步在公司内建立一个功能性的临床研究团队。
Qualifications:
Education/Experience:
MD with oncology training preferred;
10-year minimum experience in clinical practice treating patients and pharmaceutical industry experience as a sponsor working on investigational new drugs;
Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations;
A proven success record in Phase I-III clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings.
Knowledge, Skills and Abilities:
Knowledge of relevant China FDA, US FDA, and Australia TGA regulations; experience in interactions with China FDA and US personnel is essential; experience in interactions with other health authorities a plus;
Experience with, or strong knowledge of oncology drug development;
Experience or knowledge of anti-hyperuricemia/gout drug development a plus;
Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines;
Must have excellent leadership and interpersonal skills, a results- oriented work ethic, a team builder management style, and must be willing and able to be “hands on”;
Must have the highest personal values and ethical standards.

任职资格：
教育/经验：
md以及肿瘤培训优先；
10年临床治疗经验的患者最低和制药工业的经验有赞助商working on investigational New Drugs；
multiple年管理经验领导集团包括临床/临床医学系及临床操作；
a交流成功记录在第一阶段III临床研究研究与试验设计as well as the successful submission of实业和营销专业的审批备案。
知识，技能和能力：
knowledge of属于中国FDA，FDA和澳大利亚TGA规例；experience in互动以及中国和美国FDA的工作人员是必要的；相互作用以及其他卫生当局的经验更加；
experience with，金强knowledge of肿瘤药物开发；
experience or knowledge of抗高尿酸血症药物开发了/味道；
must have a thorough knowledge of Clinical Research and practices，概念，和ICH GCP指导方针；
有优秀的领导能力和人际技能must，结果导向的工作准则，有团队管理者的风格，and must be able to be”愿意与我们的手”；
must have the highest个人价值和道德标准。
Work Environment:
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required.
工作环境：
这是一个高成长、快节奏的小组织。在一个紧张的工作环境中生产和成功的能力是至关重要的。愿意和有能力在国内和国际出差。

其他要求

招聘人数：1人
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。