Biopharmaceutical Clinical Operations Professional
San Antonio, Texas Area
Gary Gonzales, MS, MBA – Drug development professional with over 20 years of industry experience in academic, biotechnology, and CRO settings. Directly contributed to each stage of Lemtrada™ (alemtuzumab) development during 10-year tenure on program. Experienced in pre-phase II/III activities (eg, study feasibility, protocol design, interaction with regulatory authorities, collaboration with medical experts) and Phase II/III activities...
Gary Gonzales, MS, MBA – Drug development professional with over 20 years of industry experience in academic, biotechnology, and CRO settings. Directly contributed to each stage of Lemtrada™ (alemtuzumab) development during 10-year tenure on program. Experienced in pre-phase II/III activities (eg, study feasibility, protocol design, interaction with regulatory authorities, collaboration with medical experts) and Phase II/III activities (eg, pivotal trial management and database lock) and marketing application filing (eg, sBLA).Vice President, Clinical Operations @ From June 2014 to February 2015 (9 months) Senior Director, Clinical Development @ From April 2012 to June 2014 (2 years 3 months) San Antonio, Texas AreaAssociate Director, Clinical Research @ From 2006 to April 2012 (6 years) Clinical Project Manager @ From 2004 to 2006 (2 years) Associate Clinical Project Manager @ From 2002 to 2003 (1 year) Senior Clinical Research Associate @ From 2001 to 2002 (1 year) Clinical Research Associate @ From 2000 to 2000 (less than a year) Clinical Research Associate @ From 1998 to 2000 (2 years) Research Assistant II @ From 1997 to 1997 (less than a year) Associate Clinical Data Analyst @ From 1997 to 1997 (less than a year) Research Assistant @ From 1996 to 1996 (less than a year) Laboratory Technician @ From 1994 to 1996 (2 years) Master of Business Administration (MBA) @ University of the Incarnate WordGradudate Certification in Project Management @ University of the Incarnate WordMaster of Science (MS), Biology @ University of the Incarnate WordBachelor of Science (BS), Biology/Chemistry @ St. Mary's University Gary Gonzales, MS, MBA is skilled in: Clinical Development, CRO, Oncology, Clinical Trials, GCP, Medicine, Neurology, Clinical Research, Drug Development, Biotechnology, CTMS, Project Management, Psychiatry, Clinical Monitoring, Pharmaceutical Industry, FDA, ICH-GCP, Therapeutic Areas, EDC, Regulatory Submissions, Clinical Operations, IND, Protocol, Regulatory Affairs, Immunology, Global Program..., Multiple Sclerosis, Volunteer Management, Clinical Study Design, Pharmacovigilance, Vaccines, Medical Affairs, Endocrinology, Lifesciences, Infectious Diseases, Monoclonal Antibodies
XBiotech USA Inc.
Vice President, Clinical Operations
June 2014 to February 2015
INC Research
Senior Director, Clinical Development
April 2012 to June 2014
San Antonio, Texas Area
Genzyme
Associate Director, Clinical Research
2006 to April 2012
Genzyme
Clinical Project Manager
2004 to 2006
Genzyme
Associate Clinical Project Manager
2002 to 2003
Genzyme
Senior Clinical Research Associate
2001 to 2002
Genzyme
Clinical Research Associate
2000 to 2000
Quintiles
Clinical Research Associate
1998 to 2000
ILEX Oncology
Research Assistant II
1997 to 1997
ILEX Oncology
Associate Clinical Data Analyst
1997 to 1997
University of Texas Health Science Center at San Antonio
Research Assistant
1996 to 1996
University of Texas Health Science Center at San Antonio
Laboratory Technician
1994 to 1996
University of the Incarnate Word
Master of Business Administration (MBA)
University of the Incarnate Word
Gradudate Certification in Project Management
University of the Incarnate Word
Master of Science (MS) Biology
St. Mary's University
Bachelor of Science (BS) Biology/Chemistry
What company does Gary Gonzales, MS, MBA work for?
Gary Gonzales, MS, MBA works for XBiotech USA Inc.
What is Gary Gonzales, MS, MBA's role at XBiotech USA Inc.?
Gary Gonzales, MS, MBA is Vice President, Clinical Operations
What industry does Gary Gonzales, MS, MBA work in?
Gary Gonzales, MS, MBA works in the Biotechnology industry.
Who are Gary Gonzales, MS, MBA's colleagues?
Gary Gonzales, MS, MBA's colleagues are Prasant Mohanty, Ann-Marie Kiser, Queena CGA, Kevin Sunley, Awo, Kankam, and Kelly Thornburg
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