Bio

Clinical Manager, Clinical & Business Development • Strong clinical development and regulatory affairs knowledge for CAR-T and TCR-T cell therapies for oncology • Led company’s cross-functional departments to complete a Phase II IND submission to U.S. FDA • Liaises with CRO to coordinate clinical operational activities at sites, including logistical and regulatory considerations for cell-therapy products • Serves as regulatory and clinical support for various departments for CMC and clinical trial development and operations to establish company’s SOPs • Works closely with CMO and various Principal investigators (PI) for the development of clinical designs • Medical writing of regulatory documents including FDA Fast Track, Orphan Drug Designation (ODD), clinical protocols, Investigator Brochures (IB) for IND submissions • Liaises with patent agents to develop IP strategies to align R&D and clinical development to meet business objectives and to drive commercialization of company’s technologies • Provides technical analysis from clinical development perspective to evaluate new business opportunities in collaborative research efforts and in/out licensing agreements • Conduct systemic literature review for clinical development and competitive market analysis of oncology immuno-therapeutic areas (including immune checkpoint inhibitors, CAR-T, TCR-T, NK- cell therapies) for sharing with external stakeholders Certification: • Regulatory Affairs Training Program, offered by Duke University • Project Management Principles and Practices Specialization, offered by University of California, Irvine Extension • Good Manufacturing Practice (GMP), offered by Nanyang Polytechnic • Good Clinical Practice (GCP), offered by SingHealth Academy