岗位职责: 1. 作为产品研发核心团队(GPT)的成员,组织并推动团队对所负责的创新药产品制定临床研发战略与临床试验计划,通过制定综合性、跨职能的近期、中长期研发计划,推动和指导研发策略的实施,对产品研发进行全过程、全方位的管理。 Be responsible for elaboration of clinical development program strategy and planning as Global Program Core Team member, drive and guide the implementation of clinical development strategy, manage and control all the phases of clinical trials with all dimensions by establishing integrated, cross-functional, short-term and long-term program plans. 2. 担任负责产品的研发计划和相关信息收集与沟通的关键联系人,建立并维护产品核心研发团队内外部顺畅的沟通渠道,确保产品开发信息的充分、及时、全面沟通,推进问题的发现和解决。 Serve as key contact for Clinical Development Program and related information, establish and maintain appropriate communications channels within and outside the Clinical Development Program (CDP) Core Team, ensure sufficient and timely flow of information and communication, promote the identification and solution of problems. 3. 负责跟踪在研产品多项临床试验的进度与状态,同时确保不同报告系统中,产品研发信息的一致性、准确性和完整性,负责产品研发信息对内和对外沟通,负责向管理层定期报告研发进展。 Document program progress and status of clinical trials and ensure consistency, correctness and completeness of information of the clinical trial in the different reporting systems, serving as the source of valid project information for internal and external communications; be responsible for routine progress reporting to the senior management. 4. 负责定期组织和协调产品研发关键会议(包括并不限于研发策略制定会议、风险管理会议,经验教训讨论或研发预算会议),确定产品研发的关键成功因素,并协调产品组合分析、风险管理和决策,负责会议议程的制定与会议纪要的撰写,及时传达行动日志,推进产品研发核心团队(GPT)的高效工作。 Conduct or contribute to periodic key program review meetings (including, but not limited to Program Strategy meetings, Program Risk Management meetings, Lessons Learned or Program Budget reviews) in order to strive for earlier identification of critical success factors and to facilitate portfolio analysis, risk-management and decision-making; prepare meeting agendas and minutes and communicate action logs to improve the efficiency of GTP. 5. 负责建立产品研发整体预算、研发进度时间表的计划、执行与追踪,负责跟进项目的预算执行与相关临床试验的进度,并负责调整优化,保持与关键职能部门密切互动与合作。并通过整合、优化临床研发资源配置,提出临床运营解决方案,***化产品研发核心团队价值。 Establish the implementation and tracking plans for project timeline and budget; accountable for ensuring the implementation of program/projects budget and progress; be responsible of optimized budget scenarios, maintain interaction partnership with key functions; propose the optimal clinical operations solutions and promote and maximize team work value through the integration and optimization of clinical development resource allocation. 6. 负责准备、更新和调整整体产品研发计划的风险/机遇和解决方案,前瞻性识别和预测可能的临床试验进度延迟或影响临床试验质量的潜在问题,协调团队成员及时,主动地采取相应措施,及时调整运营计划。 Be responsible for preparing, updating and adjusting the holistic program risk/opportunity profile and mitigation plans; and ensure proactively identify and anticipate potential problems that may delay progress or affect project quality, and accountable for coordinating team members to take timely and active measures and adapt operation plans. 7. 规划和推动产品研发核心团队(GPT)工作流程的建立,寻求GPT团队工作流程的持续优化与改进,主动获得GPT成员的反馈。 Plan and drive establishment of workflow of GPT and seek continuous optimization and improvement, actively obtain feedback from GPT members. 8. 推动制定GPT年度目标,团队管理目标,预算执行目标,并监督实施。 Drive development of annual GPT goals, management goals at the team level and budget goals and supervise the implementation. 教育背景: 1,临床医学或药学、生物学等相关专业硕士以上学历 Education: At least Master degree in relevant scientific and/or medical, pharmacy, biology. 2,相关经验: 熟悉新药临床研究的运作模式和流程、ICH-GCP等相关法律法规;熟悉国际多中心临床研究运营模式;具有5年以上行业经验,具有3年以上全球临床研发项目管理的经验者优先; Related Experience: Rich experience in operation mode, workflow, ICH-GCP and other relevant regulations; Rich experience in global clinical operation mode; 3+ years of relevant industry experience and 1+ year experience of global project management preferred; 3,语言要求: 优秀的中英文口头和书面沟通能力,能够撰写中英文项目进展报告,能够独立主持中英文会议,能够用流利的中/英文与海外临床研发团队进行沟通与交流 Language: Fluent in both oral and written English and Mandarin, Independent writer of project progress reports and independent host of meetings in Chinese and English, Good communication with overseas teams. 4,其他技能: 熟悉中英文办公操作软件环境; Other Special: Familiarity with computer software;