Senior Director, Project Management
Hazel Gorham, PhD, is Senior Director of Project Management for Biosimilars at Worldwide Clinical Trials. Her experience spans more than two decades and includes the development and implementation of clinical development strategies for biosimilars and complex generics. Her work at Worldwide encompasses all aspects of biosimilar development, including design and execution of clinical trials, as well as engaging with regulatory agencies. Her efforts extend globally, as well, educating potential investigators and addressing regional expectations for biosimilar licensing.
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Dr. Gorham has 20+ years of clinical research experience in the pharmaceutical and CRO industries across a wide range of roles, including CRA and project manager, all focusing on developing and implementing clinical development strategies for biosimilars and complex generics. More recently, Dr. Gorham gained in-depth experience in clinical pharmacology, working closely with Phase I units. She has experience in all aspects of biosimilar development, including study design and study execution and interactions with regulatory agencies. In the last few years, she has worked in the developing regions to better understand their expectations for licensing biosimilars and educate potential investigators in the region. She has worked on over 10 biosimilar molecules across a range of products and indications, including monoclonals and insulins, in various capacities, including contributing toward regulatory and clinical strategies, feasibility, and supporting study delivery across all phases of development (Phase I-IV).
Dr. Gorham holds a PhD in microbiology from Northfield School.