Background
Mr. Giokas is a leader in the Spine Clinical Affairs & Safety team at MCRA. In his Spine experience, Mr. Giokas has led projects from IDE construction through PMA, including being the primary MCRA clinical lead for the fastest PMA approval in spine history for a cervical artificial disc. In addition to his disc replacement experience Mr. Giokas has led projects in the lumbar spine including both fusion and motion sparring devices. Mr. Giokas has designed multiple spine protocols including those with unique study designs (historically controlled, propensity matched, concurrent control and investigational studies, etc.) and consults frequently with Sponsors and the MCRA Regulatory team on a unified approach to trial design.
As the Safety Lead at MCRA, Mr. Giokas has led construction and execution of Clinical Events Committees, Data Safety Monitoring Board, and Protocol Advisory Committees across multiple indications (Spine, Neurology, Orthopedics, Wound Care, etc.). Mr. Giokas was the chief strategist in the design of the MCRA processes for safety committee management and leads recruiting efforts for safety committee physicians. Mr. Giokas has supported safety committees in all stages of product pipelines including during Early Feasability (EFS), IDE/IND, and through the post-approval process.
Education
Mr. Giokas holds Dual-Bachelor of Science degrees in Biochemistry and Microbiology from Virginia Tech University.
Experience
Prior to joining MCRA in May 2018, Mr. Giokas worked with a mid-sized sponsor on the clinical operations team. The Sponsor’s pipeline included multiple global phase III pharmaceutical IND studies. The studies included both adult and pediatric patient populations and spanned across the US, Canada, and EU.
Overview
At MCRA, Mr. Giokas leads the Spine CRO operations and provides oversight and management of all aspects of design and execution of clinical trials. Mr. Giokas manages Principal Investigators, site staff, CRO team members and third-party vendors to coordinate project deliverables and meet study timelines. As the Safety Lead at MCRA, Mr. Giokas is responsible for the oversight, design, and execution of all Safety Committees (Clinical Events Committees, Data Safety Monitoring Board, and Protocol Advisory Committees). He oversees the Safety Management Team in meeting Safety Committee deliverables to support FDA & Notified Body submissions and requests.