Director, Global Clinical Process Management Lead

also ensures alignment with ICH-GCP and applicable regulatory

. Responsibilities: Execute global clinical process management activities within GCO to promote efficiency, consistency, sustainability, and compliance with applicable regulatory requirements across GCO processes and standards. Serve as the primary GCOE point of contact for one or more GCO processes, including SOPs, Work Instructions, and related standards. Contribute to content development and collaborate with GCO Global Process Owners and Subject Matter Experts, or act as the Global Process Owner as appropriate, in the technical writing of GCO procedural documents, including SOPs, Work Instructions, templates, and tools. Lead GCO process management initiatives in collaboration with GCPC, including assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and implementation activities. Identify, support, and help advance innovative ideas that improve GCO processes, enabling effective evaluation, stakeholder alignment, and follow-through from concept through implementation. Lead document review and approval workflows. Advise on and review processes owned by other functions that impact GCO processes and related standards. Establish and maintain effective partnerships with relevant GCO and cross-functional groups, including GCP Compliance, Learning and Development, and other stakeholders as needed. Contribute to the development and strategic direction of training materials related to GCO processes. Supervisory Responsibilities: Matrix supervisory Education Required: Bachelor’s degree required, Master’s or other relevant post graduate qualification preferred. Computer Skills: Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project) Other Qualifications: Fluent English (Oral; Written) Relevant Bachelor’s degree minimum – preferred science/healthcare discipline Minimum of 8 years of experience in pharmaceutical and/or biotechnology sector Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s Experience in clinical trial process design, harmonization/optimization and implementation. Experience working in matrix environment and in global teams Excellent interpersonal, problem-solving, negotiation and conflict resolution skills Excellent organizational skills and a pre-disposition to quality management and process improvement Effective communicator (oral and written) Strong presentation skills 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. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.