John Staton Email and Phone Number
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I am a seasoned Clinical Affairs leader with over 18 years of biotechnology experience in the health care sector. Recognized for demonstrating a natural aptitude for biotechnology research, as well as for solution-driven project management. Professional focal points include molecular in vitro diagnostic, companion diagnostics, and pharmaceutical development; comprehensive experience in managing complex global clinical trials across oncology, rare disease, reproductive health, and others; leadership and line management; product lifecycle management; cross-functional collaboration; and high productivity and visibility in long-term remote positions. Delivering superior administration on the latter areas of expertise requires utilization of effective interpersonal and communication skills, team mentoring and leadership, as well as business acumen, project management and contract and budget management to support efficiency and maximum returns. Currently, I am an Associate Director, Clinical Affairs with Illumina. Under my leadership, I orchestrate cross-functional teams during multi-year validation programs supporting IVD launch. I co-founded and steered a process improvement initiative to optimize departmental procedures and work instructions. In addition, I liaise with senior leadership to ensure the company’s technological and research support structure is driving the business forward with minimal expenditures.Feel free to contact me through this profile if you wish to connect.
Agilent Technologies
View- Website:
- agilent.com
- Employees:
- 10
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Senior Manager Clinical OperationsAgilent Technologies Jan 2024 - PresentSanta Clara, Ca, Us
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Associate DirectorIllumina Apr 2023 - Jan 2024San Diego, Ca, UsOrchestrated 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. -
Manager/Sr Manager, Clinical AffairsIllumina Apr 2019 - Apr 2023San Diego, Ca, UsClinical 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.
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Manager, Clinical OperationsPrecision For Medicine Feb 2013 - Apr 2019Bethesda, Md, UsPrimary 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. -
Senior Clinical Research AssociateSynteract, Inc. Feb 2009 - Feb 2013Morrisville, North Carolina, UsClinical 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 -
Clinical Research AssociateCato Research Oct 2006 - Feb 2009Performs 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
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Project Coordinator I/IiCato Research Jun 2005 - Oct 2006Coordinated 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.
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Laboratory Manager / Research Technician IiiUnc-Ch, Department Of Immunology And Microbiology Jan 2003 - Jun 2005Laboratory 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.
John Staton Skills
John Staton Education Details
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North Carolina State UniversityBiology
Frequently Asked Questions about John Staton
What company does John Staton work for?
John Staton works for Agilent Technologies
What is John Staton's role at the current company?
John Staton's current role is Leader in IVD/CDx Clinical Operations, GCP Expert.
What is John Staton's email address?
John Staton's email address is js****@****cal.com
What is John Staton's direct phone number?
John Staton's direct phone number is +191970*****
What schools did John Staton attend?
John Staton attended North Carolina State University.
What skills is John Staton known for?
John Staton has skills like Clinical Monitoring, Oncology, Clinical Trials, Edc, Immunology, Clinical Research.
Who are John Staton's colleagues?
John Staton's colleagues are Andrija Marinkovic, Ayman Mohammed, Skidmore Mallary, John Ham, Leyla Akgün, Haha Ahhh, Aun Raza.
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