Jiao G.

• Managing cross-functional teams and oversee oncology clinical trials (Phase I/II/III) across global sites (China, AUS and US), ensuring compliance and efficient execution of study timelines. • Coordinate the clinical trial lifecycle, including planning, protocol development, risk management, and regulatory submissions. • Lead weekly cross-functional team meetings (including CO, MM, DM, PV, TM, STA, and etc.) to track progress, resolve issues, and ensure timely recruitment and data reporting. • Facilitate communication among internal teams, investigators, site staff, and external stakeholders. • Hold and present in bi-weekly safety review meeting among sponsor -CRO-PIs /site study team to discuss DLT, patient’s safety data, dose escalation (if applicable), and RP2D (if applicable) for phase I studies. • Collaborate with procurement teams to select and manage CROs and external vendors, ensuring timely deliverables and cost management. • Monitor CRO performance to ensure deliverables meet quality, timeline, and budget expectations. • Support the preparation and submission of regulatory documents, including INDs, DSURs, and clinical study reports (CSRs).

• Lead clinical trial activities for multiple global studies, including CRO/vendor/site selection and setup for Phase I-III trials. • Managed multidisciplinary teams, ensuring quality and data integrity across all clinical trial (phase I and III) activities. • Developed detailed project schedules, tracked resources, and ensured alignment with study timelines and budgets. • Oversee multiple clinical projects. Activities include (but are not necessarily limited to) managing a multidisciplinary team for designated projects to ensure quality and integrity of data, compliance with Sponsor’s SOPs, ICH GCP, relevant SOPs, and regulatory requirements. • Have a thorough understanding of how Data Management, Programming and Statistics support the clinical trial submission process. Conducted operational and scientific aspects of multiple sponsored global clinical trials by collaborating with the CRO. • Developed and maintained project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). • Attended clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. • Acted as a liaison between other departments within the company to ensure project related tasks and/or issues are addressed.

• Led site selection, study initiation, and on-site monitoring activities for global clinical trials (phase I and III). • Ensured compliance with GCP and FDA regulations through regular monitoring visits and data verification. • Collaborated with sites to resolve data queries and ensure protocol adherence. • Acted as the primary point of contact between sponsors, investigators, and site staff. • Reviews the quality and integrity of the clinical data through in house review of electronic CRF data and on-site source verification. Works with sites to resolve data queries. • Serves as mentor for junior CRAs and those new to the company and/or study.

• Specialized in oncology phase I to phase II clinical trials with a focus on immunotherapy, antibody drug conjugates, targeted therapy. • Coordinated trial activities from start-up to close-out, including enrollment, data collection, and regulatory submissions. • Provided leadership and support to clinical research teams, ensuring adherence to ICH/GCP and institutional guidelines. • Managed team performance, resolving technical and operational issues, and ensuring timely delivery of study milestones. • Build, develop, and maintain relationships with internal and external partners (coordinators, CRAs, MSLs, physicians, sponsors). • Participate in the management of departmental clinical research activities in cross-functional teams (clinical medical director, clinical administrator director, nurse manager, pharmacists)

• Provide overall coordination and facilitation of clinical research activities and protocol patient care. • Coordinated study activities across 15+ sites for immunotherapy and oncology trials. • Present on multi-functional monthly teleconferences including oncologists, autoimmune disease physicians, biomarker scientists, medical monitor, research nurses, study coordinators, data coordinators for ongoing discussion of the clinical trial progress, safety and data review. • Developed and maintained strong relationships with external partners, including CRAs, sponsors, and medical monitors. • Participate in the design, collection, shipping, and storage of protocol related blood and tissue collection.

• Conducted clinical research and biomarker analysis related to aortic diseases. • Led laboratory experiments, data collection, and manuscript preparation for grant submissions and publications. • Collaborated with clinical teams to collect tissue samples and perform protein analysis for disease-related studies.

• Clinical urine/blood/tissue samples’ and patients’ data collection of cancer patients with solid tumors from multiple hospitals. • Hands on experience of urine/blood/tissue sample collection and further labs experiments and protimocs analysis with these samples. • Work with research team together to get data analysis and cancer biomarker exploration & publication. • Support the study teams in project planning, including timelines, budget, and resource management, development of team agenda and minutes with action items. • Support the study teams, facilitates sub-team meetings, and organizes ad hoc working groups as needed to move research activities forward.