John Staton Email & Phone Number

Santa Clara, Ca, Us

San Diego, Ca, Us

Orchestrated as Clinical Affairs' Program Lead the global execution of analytical (reproducibility) and clinical validation testing for company’s next generation sequencing companion diagnostic programs with pharmaceutical partners.Served as Clinical Affairs representative in Core Team structure and Joint Development Committees with external partners and vendors for multiple programs.Presided over clinical strategy development and execution of end-to-end clinical activities spanning study design, development and execution of study timelines, resource forecasting and allocation, vendor (CRO, procurement, orthogonal testing, etc.) management, cross-functional collaboration, and contract and budget management.Piloted cross-functional teams during multi-year companion diagnostic programs supporting product launch and regulatory submission under CE-IVDD, IVDR and PMA.Consulted as subject matter expert for clinical activities during internal audits and preparation efforts for BIMO inspection.

San Diego, Ca, Us

Clinical Affairs’ Program Lead overseeing validation programs for company’s next generation sequencing companion diagnostic programs with pharmaceutical partners. Clinical Affairs' representative in Core Team structure and Joint Development Committees. Line manager to Clinical Study Managers and Clinical Research Associates.

Bethesda, Md, Us

Primary point of contact for client and cross functional teams to ensure timely execution of clinical trials. Global Clinical Lead for Phase 2/3 US and international studies (Americas, Europe and Asia/Pacific regions) in rare disease and reproductive health. Worked closely with KOLs and patient advocacy organizations to generate awareness for rare disease clinical trials. Developed and executed social media campaign for rare disease awareness and recruitment.Presented at numerous client meetings and Investigator meetings.Line manager to junior Clinical Research Associates.Performed on-site monitoring (SQV, SIV, IMV, COV) per study guidelines, WIs and SOPs.

Morrisville, North Carolina, Us

Clinical Lead and Clinical Research Associate for Phase 1/2 US and internationalstudies in hematologic and solid tumor malignancies.Performed on-site monitoring (SQV, SIV, IMV, COV) per study guidelines, WIs and SOPsTherapeutic experience: Oncology studies - Multiple Myeloma, Waldenstrom Macroglobulinemia, Solid TumorPulmonary: Chronic Obstructive Pulmonary Disease, asthma exacerbation, and cosmetic Injection

Performs and coordinates the clinical monitoring activities in accordance with GCPs and Cato's SOPs. Ensures compliance of clinical trials with federal and local regulatory requirements.Conducts site evaluation, initiation, periodic and termination monitoring visits to determine protocol and regulatory compliance, and prepares required documentation.Drafts and maintains clinical visit reports, regulatory document trackers, and study visit/subject trackers according to SOPs.Presented on protocol-specific procedures at Principal Investigator/Study Coordinator meetings.Experienced reviewing eCRFs within multiple electronic data capture systems.Clinical trial experience includes for the following protocols: Phase I immunology trial Phase I/II oncology trial Phase II diabetic peripheral neuropathy trial Phase III chronic pain management trial Phase III acute pain management trial Phase III cardiovascular device trial

Coordinated and tracked project team activities, coordinated and attended project team and sponsor meetings.Managed and coordinated clinical trial activities; advised project leader on the status of outstanding issues.Prepared meeting minutes and action items; prepared and tracked project schedules, project budgets, and team personnel responsibilities.Scheduled and attended client meetings and attended project strategy meetings; prepared work orders, Gantt charts/timelines, and meeting agendas; and filed regulatory documents.Assisted in the planning and overall coordination of an Investigators Meeting for over 125 attendees.Coordinated the development and final submission of an Investigational New Drug Application and assisted on the final submission of a New Drug Application.

Laboratory Manager:Oversaw administrative responsibilities of 12-member immunology laboratory.Managed laboratory finances, ordered/inventoried supplies and reagents, established and maintained vendor/supplier relations, maintained laboratory license and regulatory documents, and conducted annual safety reviews.Supervised radioactive and hazardous material usage in compliance with federal, state and university regulations.Research Technician III:Produced Glutamic Acid Decarboxylase protein and maintained sufficient protein quantities to investigate autoimmune regulation of Type I Diabetes.Successfully developed experimental plan to develop recombinant receptor proteins to explore vaccine therapies for Francisella tularensis. Developed, in collaboration with others, novel expression, purification and folding conditions of promiscuous T cell receptors.