Kush Dhody utilizes his 15 years of experience in clinical research and pharmaceutical product development to provide strategic direction for the implementation and execution of clinical trials and to oversee the operational delivery of clinical study programs.
As a clinician, he has managed Phase I-IV studies in a CRO environment and for mid-to-large pharmaceutical and biotechnology companies. He has also served as a study site investigator.
Dr. Dhody has held several leadership positions in clinical operations and drug development, while executing clinical development programs from IND through NDA. Serving as Clinical Program Director for several NCE development projects, he has a highly successful track record of managing diverse cross-functional teams from data management, biometrics, regulatory affairs, clinical compliance and pharmacovigilance, and of serving as liaison for investigators and clinical site staff to achieve overall project delivery.
Additionally, Dr. Dhody has written/developed 20-plus protocols and prepared several individual and integrated study reports and co-lead teams in preparation of ISEs and ISSs.
His areas of expertise include:
- Good Clinical Practice (GCP)
- Clinical project management
- Clinical monitoring
- Trial design and execution strategy
- Clinical development consulting