Lisette Gonzalez

Lisette Gonzalez Email and Phone Number

Owner, Phase 2 Phase Consulting, Inc @
Lisette Gonzalez's Location
New York City Metropolitan Area, United States
Lisette Gonzalez's Contact Details

Lisette Gonzalez work email

Lisette Gonzalez personal email

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About Lisette Gonzalez

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.

Lisette Gonzalez's Current Company Details
Phase 2 Phase Consulting, Inc

Phase 2 Phase Consulting, Inc

Owner, Phase 2 Phase Consulting, Inc
Lisette Gonzalez Work Experience Details
  • Phase 2 Phase Consulting, Inc
    President, Clinical Research Consultant
    Phase 2 Phase Consulting, Inc Jan 2007 - Present
    Bellerose, Ny
    Established 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
  • Nyu College Of Dentistry, Graduate Program In Clinical Research
    Adjunct Instructor
    Nyu College Of Dentistry, Graduate Program In Clinical Research Jan 2009 - May 2012
  • Osi Eyetech
    Senior Manager, Clinical Development
    Osi Eyetech May 2003 - Dec 2006
    Managed 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.
  • Daiichi Sankyo
    Manager, Clinical Development
    Daiichi Sankyo Mar 1997 - May 2003
    Managed 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.
  • United Biomedical, Inc
    Coordinator, Clinical Trials
    United Biomedical, Inc 1993 - 1997
    Managed Phase 1/2 domestic and international vaccine and immunotherapeutic trials and clinical trials for in vitro diagnostic ELISA products.
  • Biomérieux (Formerly Analytab Products Inc.)
    Manager, Marketing Support
    Biomérieux (Formerly Analytab Products Inc.) 1981 - 1993

Lisette Gonzalez Skills

Clinical Trials Clinical Development Clinical Research Infectious Diseases Gcp Ctms Pharmaceutical Industry Regulatory Submissions Clinical Monitoring Ophthalmology Regulatory Affairs Quality Assurance Laboratory Clinical Microbiology System Monitoring Clinical Pharmacology Vaccines Phase 1 Phase 2 Through 4 Pharmaceuticals Monitoring Hiv Anti Infectives Cardiovascular Diagnostics Test Kits Trials Hepatitis C

Lisette Gonzalez Education Details

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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