Associate Director/ Director, GCO Clinical Program Lead

General Description: Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCO Program Lead is accountable for the strategic operational planning and clinical operational performance, of designated programs and acts as a point of escalation for the resolution of issues of the studies within responsible program(s). Lead the gCSMs in designated programs, provide inspirational leadership, facilitate proactive risk and issue management, and deliver feedback-oriented mentorship to the gCSM line reports, fostering talent development. Partner with other program leads/functional representatives in BeiGene R&D to drive disease/asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at the program level. Essential Functions of the job: Strategic leadership and management Accountable and responsible for building, developing and retaining the global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management. Oversee the delivery and goal achievement of projects within the designated program(s), serving as the point of escalation for resolving issues that gCSM cannot resolve. Collaborate with the other GCPLs to define and implement strategies and key priorities across-programs, and establish global standards for goals, performance measures, and capability development for the gCSM roles. GCO Representative for the designated program(s) In coordination with Franchise Head, Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the program strategy and ensure excellence in execution. Lead/participate in the KOL engagement activities in the designated programs and may act as function spokesperson if needed. Program Management Evaluate and develop strategic feasibility and budget estimates during Early Planning for new CDPs and upon strategy change during the conduct of a study, where needed. Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from early planning to the gCSM. Create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant DCT goals for the program. Create, review, and provide input to and maintain compound-level documents such as IB, DSUR, and protocol. Oversee timely, quality, and efficient study planning and execution of associated studies within the allocated program. Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to the DCT/DRC-approved budget and timeline. Report on study status, goals, and operational KPIs, and enforce quality KPIs with support from the Compliance team. Collaborate with other GCPLs to evaluate and designate preferred global vendors and participate in vendor governance meetings. Create or review performance and development plans for direct reports, facilitate and support delivery of performance and development goals. Provide line management and mentorship to gCSMs working within the designated program(s). Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function. Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization. Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements. Point of escalation for all compound-related issues. Identify and drive process improvement initiatives in collaboration with Franchise Head and/or other GCPLs within program. Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals. Supervisory Responsibilities: Line managing direct reports Computer Skills: Microsoft Office Other Qualifications: Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment. Experience in both people management and program management preferred. Travel: Travel might be required as per business need. Education Required: Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ experience in clinical trial industry. Technical Skill Transferrable Skills across GCO Continuous Improvement: Data Analysis, Issue Resolution, Quality Management, Regulatory Compliance, Root Cause Analysis, Schedule Management, Training Technical Skills for program and study management Clinical Documentation and Records Management Clinical Operations Management Contract Management Data Management Feasibility Studies Project / Program Design Project / Program Management Risk Management Technical Reporting Resource Management 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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