Lily Wong
Clinical Research and Development
Lily has over 19 years of experience across clinical research, regulatory affairs and quality management in the medical technology and healthcare sectors. Her expertise spans the planning, development and implementation of research programs, with particular emphasis on early-phase clinical development.
Lily has worked extensively with investigators, clinicians, site research teams and industry partners to develop and implement complex clinical trials. She has nearly a decade of experience in paediatric oncology research at Sydney Children’s Hospitals Network, contributing to international research collaborations to advance the development of novel treatments for children with high-risk cancers. Her work includes Phase I/II trials incorporating precision medicine approaches, molecularly targeted drug combinations and immunotherapies, including CAR-T cell therapy.
Her experience covers the clinical research lifecycle, from protocol development, regulatory and ethics submissions, through to study start-up, site activation, trial operations, safety oversight and data management. She has managed international multi-centre studies with participating sites across Australia, Canada and Europe.
Lily holds a Bachelor of Engineering (Mechanical (Biomedical)) Honours Class I, Bachelor of Commerce (Finance and Accounting), and Master of Public Health. Her multi-disciplinary qualifications provide a strong foundation in biomedical science, research methodology, business management and healthcare systems.
At DevDx, Lily provides specialist clinical research expertise to support medical device, diagnostic, and biotechnology companies in translating innovative products to clinical application, generating the evidence needed to support regulatory approval and commercialisation.
Key Service Areas:
- Clinical research strategy and clinical investigation planning
- Early-phase and first-in-human clinical trials
- International multi-centre clinical trials
- Study design, protocol and Investigator’s Brochure development
- Site feasibility and selection
- Research ethics and regulatory submissions
- Study start-up, site initiation and activation
- Clinical trial project management
- Site monitoring, trial oversight and study close-out
- Case report form and EDC design
- Data management and quality control
- Safety reporting, pharmacovigilance and DSMC coordination
- GCP compliance and quality management
- Investigator, site and industry stakeholder engagement