化学药研发项目副总监| Project Associate Director, Small Molecule Drugs Development & Governance

岗位职责| Key Responsibilities 1. 项目规划与治理管理| Project Planning & Governance 负责小分子研发项目全生命周期项目管理工作，覆盖项目立项、规划、执行、监控、阶段门评审及项目结项。 Lead end-to-end project management activities across the small molecule development lifecycle, including project initiation, planning, execution, monitoring, stage-gate reviews, and project closure. 协助项目负责人（Project Leader）制定项目章程、项目管理计划、主计划、关键里程碑、关键路径、工作分解结构、职责矩阵及关键交付物。 Support Project Leaders in developing Project Charters, Project Management Plans, integrated timelines, key milestones, critical paths, Work Breakdown Structures (WBS), RACI matrices, and key deliverables. 建立并维护项目范围、进度、预算和资源基线，确保项目目标和执行路径清晰可控。 Establish and maintain project scope, schedule, budget, and resource baselines to ensure project execution remains aligned with approved objectives. 建立项目治理机制、沟通机制及管理汇报体系，确保项目符合公司项目治理要求。 Establish governance processes, communication mechanisms, and reporting structures to ensure compliance with corporate project governance standards. 2. 项目执行与跨部门协同| Project Execution & Cross-functional Coordination 推动早期研究、CMC开发、IND申报支持、技术转移、工艺验证、生产放大及商业化准备等项目活动按计划推进。 Drive project execution across early research, CMC development, IND/BLA submission support, technology transfer, process validation, scale-up, and commercialization readiness activities. 协调研发、工艺开发、分析开发、制剂开发、质量、法规、临床、生产、供应链、采购及财务等跨职能团队协作。 Coordinate activities across Research, Process Development, Analytical Development, Formulation Development, Quality, Regulatory Affairs, Clinical Development, Manufacturing, Supply Chain, Procurement, and Finance functions. 跟踪关键里程碑、关键路径及核心交付物状态，及时识别项目偏差并推动解决方案落地。 Track critical milestones, critical path activities, and key deliverables; identify deviations and drive resolution plans to maintain project objectives. 管理外部合作伙伴（CRO、CDMO及供应商），确保项目高质量交付。 Manage external partners, including CROs, CDMOs, and suppliers, to ensure quality, timeline, and delivery expectations are achieved. 3. 风险、问题与变更管理| Risk, Issue & Change Management 建立并维护项目风险登记册、问题台账、行动项清单及决策记录。 Develop and maintain project Risk Registers, Issue Logs, Action Trackers, and Decision Logs. 组织风险识别、风险评估及风险缓解活动，推动风险预防和控制措施落地。 Facilitate risk identification, assessment, mitigation planning, and implementation of risk control measures. 推动跨部门问题分析与闭环管理，确保关键问题及时解决。 Drive cross-functional issue resolution and ensure timely issue closure. 组织项目范围、时间、预算及资源变更评估和审批流程，确保项目变更受控。 Lead project change control processes covering scope, timeline, budget, and resource changes. 对重大风险、重大偏差及关键决策事项及时预警，并推动升级管理。 Escalate major risks, project deviations, and critical decisions to governance bodies and leadership teams when necessary. 4. 项目预算与资源管理| Budget & Resource Management 协助项目预算编制、预算基线建立及资源需求规划。 Support budget planning, baseline establishment, and resource forecasting activities. 跟踪预算执行情况，开展预算偏差分析、Forecast/LE管理及预算风险预警。 Monitor budget performance, perform variance analysis, support forecasting/Latest Estimate (LE) processes, and identify financial risks. 协调财务、采购及供应链团队，确保项目预算和资源投入与项目计划保持一致。 Collaborate with Finance, Procurement, and Supply Chain teams to align project investments with approved plans. 5. 项目治理与管理层汇报| Governance & Executive Reporting 组织项目例会、专项协调会、风险评审会、预算回顾会及阶段门评审。 Organize project governance meetings, risk reviews, budget reviews, cross-functional workshops, and stage-gate reviews. 编制项目周报、月报、项目健康度报告（Dashboard）及管理层汇报材料。 Prepare weekly reports, monthly reports, project dashboards, and executive presentations. 支持项目治理委员会及管理层对项目关键节点、资源需求、重大风险和战略事项进行决策。 Support governance committees and leadership teams in decision-making related to project milestones, resource allocation, strategic priorities, and critical risks. 确保项目符合质量体系、法规要求及项目治理体系要求。 Ensure projects comply with quality systems, regulatory requirements, and internal governance standards. 6. 项目复盘与持续改进| Project Close-out & Continuous Improvement 组织项目结项、经验教训总结及知识管理活动。 Lead project closure activities, lessons learned reviews, and knowledge management initiatives. 推动项目管理流程、方法、工具和模板持续优化。 Continuously improve project management processes, methodologies, tools, and templates. 支持组织项目管理能力建设和项目治理成熟度提升。 Support organizational capability building and project governance maturity improvements. 任职要求| Qualifications 教育背景| Education 有机化学、药学，制药工程等相关专业硕士及以上学历，博士优先。 Master's degree or above in Organic Chemistry, Biochemistry, Pharmaceutical Engineering, or related disciplines. PhD preferred. 工作经验| Professional Experience 5年以上化药行业相关工作经验。 Minimum 5 years of experience in the small molecule industry. 其中3年以上化药研发、CMC开发、技术转移、注册申报支持或项目管理经验。 At least 3 years of experience in small molecule development, CMC development, technology transfer, regulatory submission support, or project management. 具有药物发现项目的经验者优先。 Experience with discovery, late phase development is preferred. 具有IND申报、工艺放大、技术转移、GMP生产支持或商业化准备经验者优先。 IND submission support, process scale-up, technology transfer, GMP manufacturing support, or commercialization experience is highly desirable. 专业能力| Technical & Project Management Competencies 熟悉化药研发全生命周期管理。 Strong understanding of the chemistry development lifecycle. 熟悉项目规划、关键路径管理、里程碑管理、预算管理、风险管理、问题管理及变更管理。 Solid knowledge of project planning, critical path management, milestone management, budget control, risk management, issue management, and change management. 具备项目治理、阶段门管理、项目状态报告及管理决策支持经验。 Experience in project governance, stage-gate management, project reporting, and executive decision support. 熟悉GMP、药品注册法规及质量管理体系要求。 Familiarity with GMP requirements, regulatory frameworks, and quality management systems. 通用能力| Core Competencies 优秀的沟通协调能力和项目推动能力。 Excellent communication, stakeholder management, and project execution skills. 良好的逻辑分析能力、风险识别能力和问题解决能力。 Strong analytical thinking, risk identification, and problem-solving capabilities. 具备复杂矩阵组织环境下的跨部门协同经验。 Proven ability to work effectively within complex matrix organizations. 具备较强责任心、结果导向意识及抗压能力。 Strong sense of accountability, results orientation, and ability to work under pressure. 良好的中英文书面及口头沟通能力。 Strong verbal and written communication skills in both Chinese and English. 优先条件| Preferred Qualifications PMP认证或同类项目管理认证。 PMP certification or equivalent project management qualifications. 熟悉Microsoft Project、Planisware、Smartsheet、Jira、Veeva等项目管理系统。 Experience with project management systems such as Microsoft Project, Planisware, Smartsheet, Jira, or Veeva. 具有CRO/CDMO管理经验。 Experience managing CROs, CDMOs, and external strategic partners. 具有大型制药企业、跨国药企或创新药企业项目管理经验。 Experience in multinational pharmaceutical companies or innovative biotech organizations is preferred.