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Lisette Gonzalez is a clinical research professional with over 25 years of experience in small start-up and large domestic and international corporations. Her background integrates scientific training with clinical trials, business management, monitoring, quality assurance and client support responsibilities. As President of Phase 2 Phase Consulting, Inc., Ms. Gonzalez enables organizations to achieve regulatory goals and requirements while maintaining compliance in all phases of clinical trials.Prior to starting her firm, Ms. Gonzalez managed Macugen® trials for OSI (Eyetech) Pharmaceuticals, a public company focused on developing and commercializing high-quality and novel pharmaceutical products for patients. Earlier, she managed and monitored all phases of clinical trials in the U.S. for Daiichi-Sankyo, Inc., the second largest drug company in Japan. Her expertise allowed for the timely submissions of New Drug Applications that resulted in FDA approval for three drugs for Daiichi Sankyo and OSI. Ms. Gonzalez also previously worked for United Biomedical, Inc., an entrepreneurial vaccine, therapeutics and diagnostics company. There she managed and monitored clinical trials for infectious disease tests to be used in the blood bank, managed and monitored NIH and company-sponsored vaccine trials and prepared regulatory submissions to FDA. In addition, she spent 12 years at a medical diagnostic division of American Home Products (Wyeth now Pfizer), where she held several positions in the laboratory and marketing department.
Phase 2 Phase Consulting, Inc
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President, Clinical Research ConsultantPhase 2 Phase Consulting, Inc Jan 2007 - PresentBellerose, NyEstablished a consulting firm to assist Pharmaceutical and Biotech Corporations and Contract Research Organizations outsourcing Clinical Trial Management, Monitoring and Quality Assurance functions achieve regulatory goals and requirements while maintaining compliance in all phases of clinical trials
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Adjunct InstructorNyu College Of Dentistry, Graduate Program In Clinical Research Jan 2009 - May 2012 -
Senior Manager, Clinical DevelopmentOsi Eyetech May 2003 - Dec 2006Managed the North American clinical programs for three Phase 3 studies assuring adherence to protocol, timelines, and budget while interfacing with other departments to ensure successful implementation of studies. Two of these studies resulted in an NDA submission and regulatory agency approval.
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Manager, Clinical DevelopmentDaiichi Sankyo Mar 1997 - May 2003Managed and monitored two pivotal Phase 3 studies while concurrently managing four Phase 1 bio equivalence studies resulting in an NDA submission and regulatory agency approval. Responsible for Phase 1- 4 Protocol development (development, review and finalization) and case report form design in addition to management of Contract Research Organizations (CROs) used for the conduct of Phase 1- 4 studies. -
Coordinator, Clinical TrialsUnited Biomedical, Inc 1993 - 1997Managed Phase 1/2 domestic and international vaccine and immunotherapeutic trials and clinical trials for in vitro diagnostic ELISA products.
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Manager, Marketing SupportBiomérieux (Formerly Analytab Products Inc.) 1981 - 1993
Lisette Gonzalez Skills
Lisette Gonzalez Education Details
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Medical Laboratory Sciences -
The Mary Louis AcademyCollege/University Preparatory And Advanced High School/Secondary Diploma Program
Frequently Asked Questions about Lisette Gonzalez
What company does Lisette Gonzalez work for?
Lisette Gonzalez works for Phase 2 Phase Consulting, Inc
What is Lisette Gonzalez's role at the current company?
Lisette Gonzalez's current role is Owner, Phase 2 Phase Consulting, Inc.
What is Lisette Gonzalez's email address?
Lisette Gonzalez's email address is lg****@****ing.com
What is Lisette Gonzalez's direct phone number?
Lisette Gonzalez's direct phone number is +180136*****
What schools did Lisette Gonzalez attend?
Lisette Gonzalez attended Hunter College At The City University Of New York, The Mary Louis Academy.
What skills is Lisette Gonzalez known for?
Lisette Gonzalez has skills like Clinical Trials, Clinical Development, Clinical Research, Infectious Diseases, Gcp, Ctms, Pharmaceutical Industry, Regulatory Submissions, Clinical Monitoring, Ophthalmology, Regulatory Affairs, Quality Assurance.
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Lisette Gonzalez
Software Engineer | Laravel | Symfony | Asp.Net Mvc | Vue.Js | Nuxt | BootstrapUnited States -
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3elsol.ie, gmail.com, burlcobar.org
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Lisette Gonzalez
Hawthorne, Nj
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