高级临床医学经理/临床副总监 上海

月薪： 2.5-3万/月

该公司所有职位
  • 无工作经验
  • 招2人
  • 英语熟练
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 餐饮补贴
  • 专业培训
  • 通讯补贴
  • 绩效奖金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： GENERAL SUMMARYProvides medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices. Also may assist Business Development group in tasks related to marketing and selling PRA services.ACCOUNTABILITIES?Supports Business Development by providing medical expertise to identify, acquire, and win new businessoBuilds relationships with new customers, maintains client relationships to obtain repeat business, identifies new business opportunities through contacts, literature, and conferencesoPromotes WuXiPRA through active i***olvement in scientific meeting, and speaking engagementsoContributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational executionoAttends bid defense meetings including generating presentations and, takes active role in RFP discussions with clientsoSupports BD in client contacts to discuss portfolio and development strategiesoTake leadership of medical monitoring tasks as a medical lead of clinical trials?Provides medical expertise on drug development and, benefit/risk evaluations throughout life- cycle of compoundoSupports study design, generation of study protocol, I***estigators Drug Brochure, and other study material, selection, and recruitment of i***estigational sitesoLeads and/or contributes to discussions with regulators and/or i***estigators, opinionleaders, internal and external clients, and project team supportoSupports the feasibility group in developing feasibility plan and questionnaire, in determining type of i***estigational sites and in selecting countries and sites. Reviews feasibility results and report.?Takes leadership of medical monitoring tasks of clinical trialsoProvides medical/scientific expertise to project teams including site questions on inclusion/exclusion criteriaoDevelops, reviews and revises protocols, case report forms, training materials, project specific tools, analysis plans design, and clinical trial reportsoLeads the review of laboratory values, adverse events, coding dictionaries and data tables, listings and figures as neededoAssists in the preparation of materials for i***estigator meetings and participate in i***estigator meetingsoAssumes responsibility for medical and safety monitoring on assigned projectsoProvides support for DMC and CEC management?Supports generation of publications and expert reportsoReviews and interprets study results and reportsoGenerates expert reports and supports IAS/IAEs , NDAs/PLAs, and other regulatorysubmissions as well as generates and/or reviews publications, posters, and scientificpresentations oEvaluates spontaneous reports and literature cases, provides individual and cumulative benefit/risk assessments, communicates with reporting health care professionals, experts and consumers, reviews and authorizes Periodic Safety Update Reports, evaluates safety issues, designs and/or leads i***estigations, recommends interventions to clients, and contributes to hearings at regulatory agencies and/or court?Develops and provides trainingoProvides therapeutic training relevant to specific study to project team, attends and/or presents at I***estigator, internal and external project team meetingsoDevelops and implements training for PMs, CRAs, CSAs, CDCs, STATS, AP, DP, medical monitoring monitors, medical writers; serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employeesQUALIFICATIONS?Licensed physician with post graduate degree?Physician specialty in CNS/Oncology is preferred?At least 5 years clinical practice experience and clinical research experience required?Pharma or CRO experience preferred?Knowledge of regulatory requirements preferred?Good communications skills required?Project leadership/management skills preferred?Experience using computerized systems (PC-Windows and MS Office)?Read, write, and speak fluent English 职能类别： 医药技术研发人员

联系方式

上海市黄浦区马当路388号SOHO复兴广场A座19层

公司信息

上海康德弘翼医学临床研究公司是药名康德全资子公司，药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 十多年来，药明康德成功打造了全方位一体化的研发服务技术平台。创建之初，药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来，我们又新增了一系列一体化服务，包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。 从 2000 年 12 月创立至今，药明康德的员工数从4 人增长至 10000 人，实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时，药明康德还在不断增强服务能力，拓宽服务领域，以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司，药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务，帮助研发出更多造福患者的新药及产品。 回望昔年，药明康德已经走过了15年的历程。15年走来，我们见证了新药研发的飞速发展，见证了众多科学家在新药研发中实现梦想，见证了全球2000多家企业攻克越来越多的疾病，见证了越来越多患者脸上渐渐浮现的微笑，同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。 未来我们的发展方向：一是继续将一体化、开放式的研发生产技术能力平台做大做强，继续延揽建立全球最尖端的医药研发技术，包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业，通过我们的平台连接“人与健康”，让国际尖端医药技术能为广大国内患者和老百姓所用。 面对2016年，回归成为私营公司的药明康德将更加专注，专注于公司创业之初变革新药研发的梦想。不忘初心，方得始终。药明康德人将继续坚守我们的初心与梦想，在新的征程中，实实在在地推动人类健康。欢迎加入药明康德大家庭，与我们携手一起开启未来，创造未来，享受未来！ 如需了解更多，欢迎访问公司网站 http://www.wuxiapptec.com.cn

上海相关职位
猎才二维码