Jose Gabriel Hilario Email & Phone Number

Melbourne, Victoria, Australia

• Secondment• Lead and manage the ongoing operational functions of the Ethics and Regulatory (E&R) Team• Lead and manage Ethics and Regulatory quality process improvements including the development and review of SOPs• Provide oversight of all project Ethics and Regulatory activities carried out by E&R team

Melbourne, Victoria, Australia

• Developed and implemented onboarding and training programs for Ethics and Regulatory specialists• Lead process improvement initiatives and development of SOPs• Acted as a representative of the Ethics and Regulatory team for internal and external audits• Actively participated in QE and CAPA activities, as well as investigations involving the Ethics and Regulatory team

Melbourne, Victoria, Australia

• Coordinated 30+ initial ethics submissions and 200+ amendments for the company’s portfolio of First-in-human and Phase I clinical trials• Acted as the single point of contact for local and international sponsors (small biotech to big pharma) during the start-up process for all ethics and regulatory-related matters• Drafted ethics application forms, participant-facing documents including informed consent forms, and other HREC requirements• Regularly corresponded with project managers, service providers, and Human Research Ethics Committees (HRECs) to address key requirements in a timely manner• Held detailed knowledge and understanding of local regulatory requirements and processes of multiple Australian HRECs • Contributed to process improvement by creating new standard operating procedures and guidance documentation

Melbourne, Victoria, Australia

• Rigorously screened 5000+ participants for Phase I clinical trials using standards underpinned by Good Clinical Practice (ICH-GCP) • Assessed participants based on study inclusion/exclusion criteria, explained clinical trial documents (schedules, Informed Consent Forms (ICFs), and other study-related material), and scheduled medical screening appointments• Liased with internal stakeholders such as clinical research coordinators, medical officers, and marketing to maximize recruitment capacity while prioritising participant safety and clinical research integrity

Brisbane, Queensland, Australia

•Designed and executed a research project in the field of synthetic biology under the Vickers Group•Utilised molecular biology and metabolic engineering laboratory techniques to generate multiple yeast strains designed to produce potentially therapeutic, commercially valuable compounds•Coordinated regular meetings with my supervisor to report weekly progress, meet project deadlines, and satisfy project objectives through quality output

Manila

•Designed and executed experiments to elucidate neurodegenerative disease mechanisms•Communicated the scientific and medical relevance of the project through oral and poster presentations in domestic and international conferences to promote stakeholder engagement•Frequently coordinated with suppliers, regulators, and stakeholders to fulfill project requirements and objectives•Created a database and kept track of project reagents, materials, and equipment•Ensured compliance of the project with local regulations and safety standards•Guided and provided training for three thesis students on proper experimental design, and routine molecular biology laboratory and cell culture techniques

Master'S Degree, Biotechnology

Activities and Societies: AusBiotech, FilOz UQMember, AusBiotech Events and Logistics Head, FilOz UQ 2019-2020

Bachelor Of Science - Bs, Molecular Biology And Biotechnology, Magna Cum Laude

Thesis student, Disease Molecular Biology and Epigenetics Laboratory Externals Chairperson, UP Molecular Biology and Biotechnology Society.