Mignon Keaton Email and Phone Number
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I am a scientist turned clinical research professional with over 16 years of experience in clinical operations, project management, and data analysis, with a PhD in Molecular Cancer Biology and a PMP certification. I also have multiple publications in peer-reviewed journals on topics such as cancer, metabolism, epigenetics, and genomics.In my most recent role, I provided study/program oversight for global Phase III cell therapy clinical trials in chronic kidney disease, managing a clinical operations team, overseeing vendors, and collaborating with cross-functional teams. I create strategic plans to meet the goals set by the executive team while also managing risks and ensuring quality. My mission is to improve lives by bringing new therapeutics to market, using my unique ability to understand the scientific, financial, and operational interdependencies that are key to a successful drug development program. I enjoy taking on leadership roles and organizational responsibilities, and I thrive in collaborative settings that require critical thinking and communication.
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Director, Clinical Science And OperationsHgi ClinicalRaleigh, Nc, Us -
ConsultantDunlin Group, Llc May 2024 - Present
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Associate Director Clinical OperationsProkidney Corp. Jul 2023 - Apr 2024Winston-Salem, North Carolina, UsProvided program oversight for global (NA, LatAm, EU, Asia regions) two Phase III cell therapy clinical trials in chronic kidney disease. Created a strategic plan to meet goals set by the executive team while collaborating with cross-functional departments. Responsibilities included:• Primary point of escalation for vendor and ProKidney cross functional teams, including including Clinical Development, Regulatory, Biometrics, Logistics, and Supply Management• Develops and manages study/program timelines and budgets• Identifies and manages risks, opportunities, and issues while also escalating them when necessary• Drives clinical vendor selection process, engaging in both the development of vendor specifications and the subsequent stages of vendor selection and contracting • Provides oversight of CROs and participates in CRO governance activities• Supervises negotiation of investigator agreements, reviews and approves budget escalations• Drives protocol development and amendments• Contributes to clinical documents including IB, DSUR, Diversity Plan, etc. and ensures integrity of clinical data• Prepares responses to regulatory agency and ethic committees comments and queries• Functions as first and second line manager for Clinical Operations team• Participates in department activities including executive reporting, project reviews, budgeting, hiring and promotions, and development of SOPs and working practices -
Senior Clinical Project ManagerProkidney Corp. Apr 2022 - Jul 2023Winston-Salem, North Carolina, UsClinical Operations lead for Phase III Global Cell Therapy trial in Chronic Kidney Disease. Responsible for CRO and vendor oversight, vendor selection, contracting, and financial oversight, site selection, and responding to regulatory (EC/IRB/RA) queries. Participates in protocol development and works cross functionally to integrate/support Regulatory Affairs, Biometrics, Clinical Development, and Pharmacovigilance with Clinical Operations. -
Sr. Project ManagerSyneos Health Feb 2021 - Mar 2022Morrisville, Nc, UsReturned to Syneos after a brief break to better support my family during COVID as Project Lead for Phase II movement disorder trial. -
Sr. Project ManagerSyneos Health (Previously Inc Research/Inventiv Health) Jan 2019 - Jul 2020Morrisville, Nc, UsProject Lead for Phase II and Phase III clinical trials in CNS (psychiatry, pain) including a large, global program in NA, EU, Asia Pacific regionsOversaw all areas of project delivery and managed cross-functional teamsImplemented Risk Based MonitoringAccountable for the financial performance of assigned projectsManaged site paymentsFunctioned as a first and second line manager for Project Managers, Project Specialists, and Clinical team members (including CRAs) -
Project ManagerPra Health Sciences Jul 2015 - Jan 2019Raleigh, North Carolina, UsProject Lead for full-service Phase II and III global clinical trials in infectious disease, addiction, and liver disease (NASH)Supported three programs and two pharma partnershipsLed transition of 15 rescue studies from three different CROs for a Sponsor portfolio. Supported partnership initiatives, established portfolio level processes and working models, and lead implementation of new systems (eTMF)Completed the Prosci Change Management Practitioner Program -
Director Of CommunicationsNcpmi Apr 2016 - Apr 2017Durham, Nc, UsOversee email communication and social media teams for NC chapter of PMI -
Team Lead - Email CommunicationsNcpmi Jun 2015 - Mar 2016Durham, Nc, UsResponsible for monthly newsletter and email communications to NCPMI members -
Program ManagerCenter For Human Genome Variation At Duke University Oct 2013 - Apr 2015The Center for Human Genome Variation (CHGV) at Duke University was led by Dr. David Goldstein until recently when Dr. Goldstein relocated to Columbia University. The Center utilized next-generation sequencing to perform genetic studies in neurodevelopmental and neuropsychiatric diseases such as epilepsy, schizophrenia, and OCD as well as studies in diagnosed diseases and precision medicine. As the program manager for CHGV, I was involved in all aspects of the administration of the Center. In this position, I was responsible for: -Financial oversight for 12 research projects totaling 12M in revenue. -Submission of new grants and contracts, including formulation of budgets, compilation of required documents, and providing scientific input on the research plan.-Management of grants and contracts including submission of progress reports and updates to project sponsors and collaborators.-Directing the daily operations of the scientific management staff including five direct reports. -Implementing process improvements and SOPs. -Prepare presentations and written communications on behalf of the Director.
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Sr. Study DirectorMetabolon Jan 2013 - Oct 2013Morrisville, Nc, UsMetabolon's mass spectrometry-based global metabolic profiling technology is used by academic and pharma-biotech investigators in diverse applications including identifying disease biomarkers, elucidating drug mechanisms of action and generating new hypotheses. As a Senior Study Director, I was involved at all stages of a metabolomics project starting with study design, project management, statistical analysis, biochemical interpretation, and generation of client deliverables. I worked closely with Sales and Marketing, IT and R&D, Laboratory Operations, and Management. In addition to my Study Director responsibilities, I managed and designed multiple aspects of several IT projects involving development of client facing tools, development of data analysis software, and generation and improvement of database features. -
Study DirectorMetabolon Nov 2011 - Dec 2012Morrisville, Nc, UsAnalysis and interpretation of metabolomic data sets generated by Metabolon's untargeted, global biochemical profiling technology. -
Postdoctoral FellowUniversity Of Virginia Health System Feb 2008 - Nov 2011Charlottesville, Virginia, UsNRSA Postdoctoral Fellowship, 1F32GM087843, NIH 2009 "Identifying Determinants of Chromosomal Domains as Defined by Time of Replication"Fields of Study: DNA replication, Cell cycle, chromosome structure, genomics
Mignon Keaton Skills
Mignon Keaton Education Details
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Duke UniversityMolecular Cancer Biology -
The University Of Southern MississippiBiochemistry
Frequently Asked Questions about Mignon Keaton
What company does Mignon Keaton work for?
Mignon Keaton works for Hgi Clinical
What is Mignon Keaton's role at the current company?
Mignon Keaton's current role is Director, Clinical Science and Operations.
What is Mignon Keaton's email address?
Mignon Keaton's email address is mk****@****lon.com
What is Mignon Keaton's direct phone number?
Mignon Keaton's direct phone number is +143424*****
What schools did Mignon Keaton attend?
Mignon Keaton attended Duke University, The University Of Southern Mississippi.
What skills is Mignon Keaton known for?
Mignon Keaton has skills like Biochemistry, Molecular Biology, Genomics, Cell Biology, Genetics, Life Sciences, Data Analysis, Project Management, Chemistry, Metabolomics, Biomarkers, Biotechnology.
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