liyuan wang

Strategic Leadership & Portfolio Delivery Led the strategic planning and operational execution for the company’s entire clinical portfolio, with a focus on cutting-edge cell therapies including TIL, CAR-T, and CAR-NKT. Successfully implemented clinical strategies for "industry-ceiling" difficulty trials, mastering the complex "Vein-to-Vein" logistics and enrollment requirements. Program Turnaround & Risk Mitigation Expertly diagnosed and rescued high-priority programs with severe delays. By implementing proactive risk mitigation plans and optimizing resource allocation, I successfully accelerated project timelines and ensured critical milestones were achieved ahead of schedule despite intense market competition. Organizational Design & Team Scaling Built and led a high-performing clinical operations department of 20+ professionals from the ground up. Established a standardized operational infrastructure and core SOPs, transforming the department into a highly efficient organization capable of supporting multiple simultaneous global-standard trials. Vendor Strategy & Cost Optimization Developed and institutionalized a rigorous framework for vendor (CRO/SMO/Central Lab) selection and oversight. Leveraged deep industry insights to lead high-stakes business negotiations, achieving multi-million RMB cost savings while elevating service quality and compliance standards. Cross-functional Synergy Served as the primary operational liaison between R&D, Regulatory Affairs, Medical, and CMC/Manufacturing to ensure seamless cross-functional alignment and resource integration, driving overall corporate strategic goals.

Organizational Design & Capability Building Spearheaded the ground-up establishment of the Clinical Operations department in alignment with corporate strategic objectives. Architected the department's foundational infrastructure, including the design and implementation of comprehensive SOPs, Clinical Quality Management Systems (CQMS), and operational governance frameworks. Led talent acquisition and capability-building initiatives to form a robust clinical team. Portfolio Strategy & Execution (e.g., CLDN18.2 mAb) Orchestrated the clinical execution strategies for the company's oncology pipeline, notably driving the CLDN18.2 monoclonal antibody program. Strategically allocated resources across distinct clinical trials and fostered deep cross-functional synergy (Medical, Regulatory, Data Management) to ensure seamless program delivery. Strategic Vendor Sourcing & Alliance Management Defined and executed the global vendor strategy. Directed the end-to-end sourcing process for CROs, SMOs, and central labs, leading high-stakes contract negotiations and establishing alliance management frameworks to ensure external partners met rigorous quality, timeline, and budgetary standards. Executive Leadership & Performance Management Defined key performance indicators (KPIs) to measure and optimize clinical operational success. Acted as a key strategic partner to the C-suite, preparing high-level business summaries and driving data-driven executive decision-making.

Full Lifecycle Clinical Program Management Led the end-to-end operational strategy and execution of high-priority clinical trials. Developed and maintained comprehensive project management plans, meticulously defining scope, resource allocation, and rigorous financial stewardship to ensure global-standard clinical delivery. Strategic Cross-functional Synergy Acted as the core operational nexus between Clinical Medical, Biometrics, and Regulatory affairs. Facilitated deep cross-functional alignment to ensure all clinical milestones consistently met stringent quality benchmarks and institutional timelines. Crisis Management & Landmark Achievement (BsAb Project) Demonstrated exceptional turnaround capabilities by taking over a critical Bispecific Antibody (BsAb) program in Gynecological Oncology that was severely delayed by over 6 months. Through radical optimization of enrollment strategies and proactive risk mitigation, successfully erased the deficit and delivered the project ahead of the original global schedule. Proactive Risk Management & Budgetary Oversight Established a robust framework for identifying, monitoring, and mitigating operational risks. Continuously optimized project workflows to ensure strict alignment with complex timelines and budgetary constraints, achieving a high degree of operational efficiency.