Introduction
An oncologist, a physician‑scientist, and a drug developer, Hariz brings a unique mix of skills to the table, drawing from his industry insight and solid clinical practice background, particularly in oncology while working both as medical lead and Chief Medical Officer (CMO). He has over 12 years of experience in clinical development, focusing on early phase programs but his expertise also extends to designing pivotal late‑phase trials and engaging directly with FDA, EMA, health technology assessment bodies and other European regulatory agencies. He has worked with multiple innovative technology platforms, advancing numerous new drugs into clinical trials, including complex CAR T‑cell therapy. Hariz implements both classical and adaptive trial designs tailored to program objectives. He has formulated and executed several clinical development plans (CDPs), target product profiles (TPPs), and authored numerous clinical study reports (CSRs), regulatory submissions, designation applications, orphan drug initiatives, briefing books, and responses to regulatory/institutional review board inquiries.
Hariz adopts a hands‑on approach to clinical development, heavily involved in protocol writing, electronic case report form (eCRF) development, medical monitoring, review, analysis, and reporting. Hariz, an experienced safety physician, is adept at identifying safety signals, formulating risk evaluation and management plans (REMPs), and contributing significantly to pharmacovigilance efforts. He also regularly assesses, manages and files serious adverse events (SAEs) as well as other key safety events, including conducting safety and dose decision meetings. He collaborates seamlessly within cross‑functional teams to implement and execute clinical studies/programs. Additionally, he has cultivated a robust network of key opinion leaders (KOLs), principal investigators (PIs), and trial sites across the USA, Europe, and Asia. Hariz frequently leads advisory boards and oversees data monitoring committees (DMCs) and steering committees. He is also actively engaged in due diligence and market access endeavors. Lastly, Hariz is deeply committed to drug development. To further his expertise, he will enroll in the MSc in Experimental and Translational Therapeutics at the University of Oxford, starting in October 2024.
Member of:
American Society of Clinical Oncology (ASCO)
European Society of Medical Oncology (ESMO)