Yira Bermudez Ph D MBA PMP RAC

•DS7300 (oncology) and DS2325 (rare disease) Operations Program Lead responsible for delivering high quality clinical operations plans by enabling efficient execution, proactively managing risk and identifying opportunities to accelerate clinical development •Accountable for the clinical operational strategy and overall delivery of clinical studies within the assigned programs •Ensure robust oversight plans, operational plan, and communication plans are in in place across studies within the assigned programs •Responsible for resolving ongoing challenges and creating strategies to prevent challenges from happening again as clinical operations representative at governance and committees •Preceptor of PharmD Fellowship in COP •Developed an optimized process framework for Clinical Pharmacology studies as Operations Program Lead •Pexidartinib (oncology) Operations Program Lead responsible for leading global and local Phase I to IV clinical studies, in adherence to GCPs, appropriate SOPs, FDA regulations, EU Directive, and ICH guidelines •Lead the study teams to develop a cross-functional, integrated study plan to study start up and created initial study budget •Reviewed study feasibility assessments provided by the CRO, select the CRO and provide input into AROs and clinical sites selection •Lead site selection and site qualification discussions with study team and CRO •Incorporated the operational delivery aspects and logistics into the protocol and lead document writing and review for the protocol and amendments •Interacted with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study Team •Validated the study implementation plan provided by the CRO through to study start up to study close out •Guided the study teams for inspection readiness at the study and program levels •Resolved issues that have been escalated or if warranted, take issues to the appropriate governance committee