As an accomplished Vice President of Clinical Operations, I bring years of clinical research experience specializing at building high functional teams and directing domestic and global clinical trials activities to successfully oversee therapeutic products in oncology, wound care, and gastrointestinal disease. I am adept in overseeing strategic and operational planning of multiple clinical programs simultaneously, ensuring projects meet established timelines and budget.My experience has allowed me to collaborate with the FDA and Ex-US regulatory agencies to navigate complex compliance requirements, such as INDs, clinical holds, orphan drug designations, and expedited programs for serious conditions. I have a proven track record implementing technologies and strategies to de-risk programs from first-in-human through registration trials, with a focus on maintaining high data quality and operational efficiency.My passion and focus is working with a collaborative team, advancing products that have the potential to positively transform patient outcomes.Key areas of expertise: Drug Development | Strategic Clinical Leadership | Clinical Operations | Clinical Trial Design & Execution | Patient Recruitment Strategy & Enrolment Optimization | Cross-functional Team Leadership | Team Building & Mentorship | Good Clinical Practice | Process Development & Improvement
Mccoy Clinical Consulting, Llc
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President And Principal ConsultantMccoy Clinical Consulting, LlcTexas, United States
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President / Principal ConsultantMccoy Clinical Consulting, Llc Nov 2023 - PresentGrapevine, Texas, United StatesProvide development strategies, leadership solutions and expertise in clinical operations for life science companies advancing products through early to late phase clinical trial settings.• Provide key team leadership stability and structure on an interim to permanent basis.• Oversee technologies and strategies to de-risk clinical programs.• Advance products that can positively transform patient outcomes.
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Vice President Clinical OperationsPalisade Bio Oct 2021 - Nov 2023Provided high-level strategic direction, management, and leadership for clinical operations for an oral therapeutic treating post-operative ileus and preventing intra-abdominal adhesions following colorectal surgery. • Responsible for building out an internal clinical team, creating a network of consultants and vendors, and standardizing operating processes and procedures for the clinical department to successfully manage and oversee multiple clinical trials within North America and China. -
Vice President Clinical OperationsTissuetech, Inc Dec 2020 - Oct 2021Hired as second clinical operations employee to provide leadership to build an internal team, develop internal processes and procedures, implement technologies to de-risk clinical programs, and oversee multiple clinical programs and clinical trials, including indications in venous leg ulcers, diabetic foot ulcers, knee and facet osteoarthritis, and ocular diseases, utilizing placental birth tissue. -
Associate Vice President Clinical OperationsTissuetech, Inc May 2019 - Dec 2020Dallas/Fort Worth Area
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Senior Director Clinical OperationsTissuetech, Inc Feb 2016 - May 2019Dallas/Fort Worth Area -
Director Clinical OperationsSmith & Nephew Dec 2015 - Feb 2016Dallas/Fort Worth AreaProvided oversight of multiple global clinical programs, including a cellular therapy program and multiple device studies, managing a US and UK clinical team, in addition to managing external consultants, vendors and CROs. -
Senior Manager Clinical OperationsSmith & Nephew Apr 2015 - Dec 2015Dallas/Fort Worth Area -
Manager Of Clinical OperationsSmith & Nephew (Formerly Healthpoint) Jul 2013 - Apr 2015Dallas/Fort Worth Area -
Principal CraHealthpoint Dec 2010 - Jul 2013Dallas/Fort Worth Area -
Site ManagerRps - Wyeth/Pfizer Nov 2006 - Dec 2010Dallas/Fort Worth Area -
Clinical Regional Site ManagerKforce - Pfizer Aug 2005 - Nov 2006Dallas/Fort Worth Area -
CraIlex Oncology Oct 2004 - Aug 2005San Antonio, Texas Area
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Data ManagementUs Oncology 2002 - 2004Dallas/Fort Worth Area
Nick Mccoy Education Details
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Biology/Chemistry -
Clinical Research Administration
Frequently Asked Questions about Nick Mccoy
What company does Nick Mccoy work for?
Nick Mccoy works for Mccoy Clinical Consulting, Llc
What is Nick Mccoy's role at the current company?
Nick Mccoy's current role is President and Principal Consultant.
What schools did Nick Mccoy attend?
Nick Mccoy attended Southern Nazarene University, The George Washington University School Of Medicine And Health Sciences.
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Nick McCoy
Finance & Accountancy Student At The University Of Illinois Urbana-ChampaignAlgonquin, Il -
Nick McCoy
Washington, Dc4akingump.com, gmail.com, akingump.com, kirkland.com3 +181769XXXXX
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Nick McCoy
Sussex, Wi -
Nick McCoy
San Francisco Bay Area
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