Clinical Lead临床项目负责人
萌蒂(中国)制药有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2018-04-18
- 工作地点:北京
- 工作经验:3-4年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:2-2.5万/月
- 职位类别:临床研究员
职位描述
l Lead clinical development team to provide scientific and clinical expertise for Go or NOGO decisions. Design clinical development programs in accordance with targeted product profile by collaborating with relevant functions.
l Lead Clinical Development Plans and be responsible for detailed study designs; initiate and support study protocol development to meet scientific and regulatory requirements for product registration in China.
l Provide scientific and clinical expertise to the clinical section of regulatory documentations and submissions.
l Act as a speaker at internal and external meetings to provide state-of-the-art medical knowledge of R&D projects as required.
l Be accountable for timely medical monitoring of the clinical trials and ensure study protocols be implemented with good medical quality.
l Lead scientific interpretation on clinical trial data and ensure clinical study report reflect scientific value with regulatory required content.
l Be accountable for scientific and clinical advice and training to other functions within the R&D organisation.
l Build, maintain and leverage networks internally and externally in order to ensure continuous medical quality and performance.
l Contribute to publications produced via clinical trials and present data at medical conferences on behalf of MCPC.
l Involve in the process optimization for clinical development projects.
任职资格:
· Broad scientific and clinical education/experience with an excellent network and connections to experts/KOLs in wide range therapeutic areas.
· Extensive knowledge of trial design, statistical methods, data analysis and medical writing.
· Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of GCP and applicable guidelines of clinical development guidelines.
· Ability to effectively manage interactions with both academic thought leaders as well as other partners ensuring optimal cooperation for achieving program and department goals.
· Understanding of market access needs and implementation of appropriate measures for health care purposes.
· Strong interpersonal skills and ability to interface effectively with company local relevant functions and global clinical development team.
· Ability to anticipate and facilitate issue resolution to meet local registration requirements.
· High leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.
· Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering high quality results and strives for continuous improvement.
· A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.
· Consistently demonstrates and encourages team members to demonstrate the Core Values of clinical development function.
· Adheres to the Company’s Compliance and Code of Business Ethics guidelines.
职能类别: 临床研究员
公司介绍
萌蒂中国制药目前在华拥有1300多位员工,业务遍布300多个城市。在北京拥有设备先进、专业生产麻醉和精神类药品的工厂。
通过20多年的不懈努力,萌蒂中国制药已成为中国癌痛领域的领导者,并引领镇痛领域。
多年来,我们一直坚持为提高人类的生活质量和健康水平而奋斗,“健康生活,品质人生”是我们的企业愿景;关爱生命,回馈社会是我们的社会责任;创新的天赋,以患者为核心的理念以及企业家精神是我们血液中的 DNA。
2018年3月,由国家卫生健康委员会扶贫办指导,《健康报》社、中国人口福利基金会健康报公益基金主办,萌蒂中国制药支持的“康萌大病救助计划”公益项目在北京正式启动,成为社会力量参与健康扶贫、大病救助的典范。
未来,萌蒂中国制药将继续深耕疼痛管理领域,同时将业务进一步拓展至抗呕吐、移植与免疫治疗、肿瘤、呼吸系统、健康消费品等全新领域,不断提供创新的产品,积极履行企业社会责任,为实现“健康生活,品质人生”的企业愿景而不懈努力。
联系方式
- 公司地址:北京市朝阳区东三环中路1号环球金融中心西楼18层 (邮编:100022)
- 电话:13811131800