Lisha Ye

MD-trained neurologist and PhD clinical scientist with 6+ years of hands-on GCP-compliant clinical investigation experience across Phase III RCTs and translational research. Proven expertise in study protocol design, Ethics Committee submissions, ICF development, regulatory documentation, biomarker analysis, and scientific reporting. Experienced in cross-functional collaboration with KOLs, international consortia, and multidisciplinary teams.

Eager to apply rigorous clinical science in a fast-moving MedTech/digital health environment. Based in Belgium; available for European and US travel.

Doctoral Researcher — Clinical Investigation & Data Science at VIB (2019-01 – 2025-01)

• Designed end-to-end clinical research protocols, defining endpoints, sample sizes, data management strategy, and biomarker collection pipelines in compliance with GCP and ethical standards
• Authored study documentation including protocols, EC submission packages, informed consent frameworks, and scientific reports for multi-site translational studies
• Managed data quality: designed collection instruments, performed data cleaning, led statistical analysis and interpretation of complex biological and clinical datasets
• Collaborated with neurologists, international consortia, and cross-functional teams to translate scientific findings into clinical development strategy
• Published peer-reviewed research (Neurobiology of Disease, 2025; Frontiers in Neurology, 2020); presented at ALS/MND Symposium and Gordon Research Conferences

Clinical Trial Assistant – Phase III RCT at Shanghai Sixth Hospital (2018-01 – 2019-01)

• Supported full lifecycle of a multicenter Phase III RCT: eligibility screening, source data verification, protocol compliance, AE documentation, and site monitoring under ICH-GCP
• Contributed to regulatory documentation, CSR preparation, and investigator site management
• Coordinated with site teams and investigators to ensure milestone and compliance adherence

Registered Physician – MD Specialist Training at Shanghai Sixth Hospital (2016-01 – 2019-01)

• Diagnosed and managed complex neurological conditions
• Conducted patient-level medical data review and contributed to hospital-based clinical research and multidisciplinary case conferences

PhD in Biomedical Sciences – KU Leuven (2019-01 – 2025-01)

MSc in Clinical Neurology – Shanghai Jiao Tong University (2016-01 – 2019-01)

BSc in Clinical Medicine – Zhejiang University (2011-01 – 2016-01)