Medical Monitor

with more independence, including participating in health authority (HA) interactions with little to no supervision from their managers. This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions. Essential Functions of the Job: Cross-Functional Team Membership Participates in and/or leads the relevant Therapeutic Team (TT) and/or represents CD in Study Team relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution. May also, as appropriate, support relevant Study Team in training new team members. As appropriate, participates in ongoing enhancements/development of core and study team processes, structures, systems, tools and other resources. Clinical Development Planning Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s). As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects. Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups. May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs together with CST and other relevant teams. Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of BeOne and patients. Clinical Development Plan Implementation Provides clinical oversight across all relevant studies and programs; leads and/or otherwise participates in ongoing TT and relevant study team meetings, other interactions and communications. Designs and develops clinical studies; collaborates with others in the development of the product safety profile and clinical sections of investigator brochures, presentations and other materials. May participate in the identification and selection of appropriate external investigators and sites. Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study. Acts as a medical monitor for assigned studies. Conducts ongoing reviews of medical/safety data. Collaborates with relevant teams and other groups to measure and monitor study progress against objectives, proactively communicate any issues, challenges and potential strategies to resolve such. Collaborates with other groups to ensure timely and appropriate completion of interim and final study reporting; accountable to ensure correct medical/scientific data interpretation for interim and final study reporting. Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies, including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials. Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment. Completes and/or leads other special projects, as and when assigned, or otherwise requested. Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, BeOne Standard Operating Procedures (SOPs) and other guidelines. Supervisory Responsibilities: N/A (CST-level role; no people-management responsibilities). Education Required: M.D. with relevant medical experience in Oncology required. Academic/teaching background a plus. >5 years pharma/biotech industry experience OR recognized expert in the field; >5 years experience with clinical trials, oncology trials

. Computer Skills: Skilled in Microsoft Office Suite Other Qualifications: M.D. with relevant medical experience in Oncology area required. Academic/teaching background is a plus. Can effectively contribute to development of disease strategies. >5 years pharma/biotech industry experience OR is a recognized expert in the field. >5 years experience with clinical trials, Oncology trials preferred. Strong orientation to teamwork. Clinical leadership: is regarded as an expert in his/her field, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results. Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such. Outstanding communication skills, both written and verbal. Travel: Up to 20%. Ability to travel domestically and internationally. 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.