1. 根据中心总体规划目标,组建方案开发与方法学平台,并组织开展业务工作; 2. 负责组织制定中心方案开发与生物统计业务工作制度、规章、操作标准等规范,并监督实施; 3. 组织对部门人员进行专业培训、指导与考核,参与部门人员招聘; 4. 负责组织部门开展与临床试验项目方案开发、统计分析工作,并在计划时间内高质量地完成; 5. 负责组织建立、维护与相关专业领域专家的良好关系,就方案开发与统计分析中遇到的专业问题与专家进行沟通咨询; 6. 负责就部门业务与中心其他相关部门进行沟通和协调,组织部门对中心其他部门提供及时、高效的技术支持; 7. 完成上级交办的其他工作。 1. Establish and manage the program development and methodology platform. 2. Develop and implement regulatory and operational standards for program development and bio-statistics. 3. Lead training, recruitment, and assessment of departmental personnel. 4. Oversee clinical trial protocol development and statistical analysis. 5. Maintain relationships with industry experts to address complex project issues.
任职要求
1. 专业经验:具有在生物医药或CRO行业10年项目开发或方法学平台工作经验,3年部门管理的工作经验,精通临床试验设计; 2. 领导能力:具有出色的领导和执行力,以及优秀的沟通、培训和演讲技能; 3. 教育背景:医学或药学博士学历; 4. 政策法规:熟悉国内国际药械监管的法律法规和产业政策; 5. 行业视野:熟悉国内外药物研究发展和现状; 6. 语言能力:具备在英语环境下胜任岗位职责的能力; 7. 特别优秀者,可适当放宽任职条件。 1. 10+ years of experience in project development or methodology within the bio-pharmaceutical or CRO industry. 2. Strong leadership and execution skills, with excellent communication and presentation abilities. 3. PhD in Medicine or Pharmacy. 4. Familiar with domestic and international regulations governing drug and device development. 5. Fluent in English with the ability to perform duties in an English-speaking environment. 6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.