首席医疗官

一、岗位基本信息 Basic Job Information岗位名称 Job Title：首席医学官 / Chief Medical Officer (CMO)所属部门 Department：医学中心 / Medical Center汇报对象 Reporting To：CEO / General Manager管理下属 Subordinates：医学事务部、临床开发部、药物警戒部、MSL团队 / Medical Affairs, Clinical Development, Pharmacovigilance, MSL Team岗位级别 Job Level：公司核心高管 / C-Level Executive岗位定位 Job Positioning中文：作为公司最高医学负责人，全面统筹公司医学战略、临床研发、医学事务、药政沟通与医学合规管理。主导产品全生命周期医学决策，平衡临床科学价值、研发风险与商业化目标，为公司管线研发、项目合作、产品上市及学术品牌建设提供核心医学支撑。English：As the top medical leader of the company, the CMO is fully responsible for corporate medical strategy, clinical R&D, medical affairs, regulatory medical communication and medical compliance management. Lead full-lifecycle medical decision-making for product pipelines, balance clinical scientific value, R&D risks and commercial goals, and provide core medical support for pipeline development, project cooperation, product launch and academic brand building.二、核心岗位职责 Core Job Responsibilities1. 医学战略与管线规划 Medical Strategy & Pipeline Planning中文：参与公司高层战略决策，结合行业临床需求、政策法规及市场趋势，制定公司中长期医学发展战略与临床管线整体规划；负责新药立项、BD引进、合作授权项目的医学尽调，输出专业医学评估报告，支撑投资与管线布局决策；统筹旗下所有产品全生命周期医学管理，涵盖早期研发、临床试验、适应症拓展、真实世界研究、上市后学术证据建设及产品标签优化。English：Participate in senior corporate strategic decision-making. Formulate medium and long-term medical development strategies and overall clinical pipeline plans based on unmet clinical needs, industry policies and market trends. Conduct medical due diligence for new drug projects, BD in-licensing and collaboration programs, and deliver professional medical evaluation reports to support investment and pipeline layout. Oversee full-lifecycle medical management of all products, including early R&D, clinical trials, indication expansion, real-world research, post-marketing academic evidence development and labeling optimization.2. 临床研发全流程把控 Clinical Development Management中文：全面负责公司创新药/医疗器械临床研发工作，审定临床试验方案、研究者手册、知情同意书、临床总结报告等核心医学文件，保障临床试验的科学性、合规性与严谨性；统筹管理CRO、研究者、研究中心等合作资源，把控临床项目进度、质量与成本；主导临床数据解读与医学研判，及时识别、处置临床试验不良事件及重大医学风险，输出关键决策建议，支撑IND、NDA等注册申报工作。English：Take full charge of clinical development for innovative drugs and medical devices. Review and approve key medical documents including clinical trial protocols, investigator brochures, informed consent forms and clinical study reports to ensure scientific rigor and compliance. Manage CROs, investigators and study sites to control clinical progress, quality and cost. Lead clinical data interpretation and medical judgment, identify and resolve adverse events and major medical risks, and provide key decision suggestions to support IND, NDA and other regulatory applications.3. 药政沟通与医学合规 Regulatory Communication & Medical Compliance中文：作为公司医学负责人，主导对接NMPA、CDE及海外FDA/EMA等监管机构，组织开展Pre-IND、IND、NDA等各类药监沟通会，负责申报资料医学板块的审核把关；搭建并完善药物警戒体系，规范SAE上报、风险评估与管控流程；建立医学事务标准化SOP体系，严格落实GCP及国内外行业法规要求，杜绝重大医学合规风险，保障研发及上市后医学活动合法合规。English：Serve as the company’s primary medical contact for NMPA, CDE, FDA, EMA and other global regulatory authorities. Organize Pre-IND, IND, NDA and other regulatory meetings, and review medical sections of registration dossiers. Establish and optimize the pharmacovigilance system, standardize SAE reporting, risk assessment and control procedures. Build standardized SOPs for medical affairs, strictly implement GCP and domestic & international regulatory requirements, eliminate major medical compliance risks, and ensure legal and compliant operation of R&D and post-marketing medical activities.4. KOL学术合作与医学事务 KOL Collaboration & Medical Affairs中文：搭建并维护国内外核心领域KOL专家资源网络，组织专家顾问会、研究者研讨会、学术论坛等各类学术活动；统筹MSL团队建设与管理，为研发、注册、市场、商业化团队提供专业医学赋能；主导IIT研究、学术共识、论文发表、临床科普等学术项目，持续构建产品学术价值体系，提升公司行业学术影响力。English：Build and maintain domestic and international KOL networks in core therapeutic areas. Organize expert advisory meetings, investigator seminars and academic forums. Oversee MSL team building and management, and provide professional medical empowerment for R&D, registration, marketing and commercial teams. Lead IIT research, academic consensus development, paper publication and clinical popularization projects, continuously build product academic value system, and enhance the company’s academic influence in the industry.5. 团队管理与跨部门协同 Team Management & Cross-functional Collaboration中文：搭建完善的医学中心组织架构，负责医学团队的招聘、培养、绩效考核与梯队建设，打造专业、合规、高效的医学人才团队；深度协同研发、生产、注册、BD、市场准入、销售等部门，打通从早期研发到产品商业化的全链条医学支撑；定期向高管层及投资人汇报临床管线进展、核心医学成果、潜在风险及未来规划。English：Establish a sound organizational structure for the Medical Center, responsible for team recruitment, training, performance management and talent echelon construction, building a professional, compliant and efficient medical team. Collaborate closely with R&D, production, registration, BD, market access and sales teams to realize full-chain medical support from early research to commercialization. Regularly report clinical pipeline progress, core medical achievements, potential risks and future plans to senior management and investors.三、任职资格要求 Job Qualifications1. 学历与资质 Education & Certifications中文：临床医学博士（MD）优先，具备执业医师资格证；药学、基础医学博士需具备丰富的临床研发高管经验。English：MD degree in Clinical Medicine is preferred with practicing physician certificate. PhD in Pharmacy or Basic Medicine with senior clinical R&D management experience is also acceptable.2. 工作经验 Work Experience中文：12年及以上生物医药、创新药行业临床研发、医学事务相关经验，5年以上企业CMO/医学副总裁/医学中心负责人高管管理经验；完整主导过创新药I-III期临床研发及NDA上市申报全流程，拥有成功获批案例者优先；具备海外临床研发、国际药监沟通经验者优先。English：More than 12 years of working experience in biomedical and innovative drug industry focusing on clinical development and medical affairs; more than 5 years of senior management experience as CMO, VP of Medical Affairs or Medical Center Director. Proven full-cycle experience in leading Phase I-III clinical development and NDA registration of innovative drugs with approved products is preferred. Overseas clinical R&D and international regulatory communication experience is a plus.3. 专业能力 Professional Competencies中文：精通NMPA、GCP及CDE审评规则，熟悉FDA、EMA等海外药监法规；熟练掌握临床试验方案设计、医学文件撰写审核、临床风险管控、药物警戒全流程；具备优秀的项目医学尽调、CRO管理、KOL资源运营能力；英文流利，可熟练读写专业医学英文资料、独立开展海外学术及监管沟通。English：Proficient in NMPA, GCP and CDE review guidelines, familiar with FDA, EMA and other international regulatory requirements. Skilled in clinical trial protocol design, medical document drafting and review, clinical risk management and full-process pharmacovigilance. Excellent capabilities in medical due diligence, CRO management and KOL resource operation. Fluent in English, capable of reading and writing professional medical documents and conducting independent overseas academic and regulatory communication.4. 综合素质 Comprehensive Competencies中文：具备高管战略思维与全局视野，可平衡科学严谨性与商业发展目标；拥有极强的跨部门沟通、统筹协调、危机处置与决策能力；恪守医学伦理与职业操守，具备极高的合规意识与责任心。English：Possess senior executive strategic thinking and global vision, able to balance scientific rigor and commercial development goals. Strong cross-departmental communication, overall coordination, crisis response and decision-making capabilities. Strictly abide by medical ethics and professional integrity with high compliance awareness and sense of responsibility.5. 优先条件 Preferred Qualifications中文：跨国药企、头部创新药企业CMO任职经历；肿瘤、自身免疫、罕见病、抗感染等核心治疗领域深耕经验；参与过企业IPO、管线并购、重大BD合作项目者优先。English：Working experience as CMO in multinational pharmaceutical companies or leading innovative drug enterprises; in-depth experience in core therapeutic areas such as oncology, autoimmune diseases, rare diseases and anti-infection; experience in corporate IPO, pipeline M&A and major BD cooperation projects is preferred.四、核心考核指标 KPI中文：1. 临床管线项目按节点高效推进，临床试验质量合规、无重大医学事故；2. IND/NDA等注册申报医学板块顺利通过审评，药监沟通高效落地；3. 搭建完善的医学合规与药物警戒体系，全年无重大合规风险事件；4. 完成KOL学术网络搭建与学术品牌建设；5. 医学团队梯队完善、能力持续提升。English：1. Efficient progress of clinical pipeline projects as scheduled with qualified clinical trial quality and no major medical incidents; 2. Smooth review of medical sections for IND/NDA applications and effective regulatory communication; 3. Establish complete medical compliance and pharmacovigilance system with zero major compliance incidents; 4. Complete KOL academic network construction and enhance corporate academic brand influence; 5. Build a sound medical talent echelon with continuous team capability improvement.五、薪酬与福利 Compensation & Benefits中文：极具竞争力年薪、年终绩效奖金、股权激励；完善的高管福利体系、带薪年假、高端体检、专项培训资源等，具体面议。English：Competitive annual salary, year-end performance bonus and equity incentive plan; complete senior executive welfare system including paid annual leave, high-end physical examination and special training resources. Package negotiable based on candidate’s background.