Gentiae Clinical Research
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Gentiae Clinical Research Employees
Precision For Medicine April 2013 - Present
Bracket June 2011 - February 2013
United BioSource Corporation April 2005 - June 2011
Dynarand March 2003 - April 2005
Gentiae Clinical Research March 2001 - April 2002
CompuMed April 1996 - February 2001
Mutual of Omaha September 1993 - April 1996
Healthways, formerly Diabetes Treatment Centers of America January 1991 - September 1993
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, Lifesciences, Medical Devices, Business Development, Clinical Development, Diabetes, CRO, Healthcare, EDC, Biotechnology, Negotiation, Awesomeness, Drug Development, Commercialization, Groovyness, Oncology, Data Management, Start-ups, CTMS, Endocrinology, Biopharmaceuticals, Infectious Diseases, Therapeutic Areas, GCP, Neurology, FDA, Vaccines, Hospitals, Medical Writing, Immunology, Pharmacovigilance, IVDs, LDTs, Companion Diagnostics, Life Sciences
Education
University of Nevada Las Vegas Lee Business School 1985 — 1989
BSBA, Marketing
University of Nevada-Las Vegas 1985 — 1989
Bachelor of Science (BSc), Specialized Sales, Merchandising and Marketing Operations
BioMarin Pharmaceutical Inc. March 2015 - Present
BioMarin Pharmaceutical Inc. July 2013 - March 2015
Amgen June 2012 - July 2013
Amgen June 2011 - August 2011
Alexza Pharmaceuticals July 2008 - May 2010
Alexza Pharmaceuticals August 2007 - June 2008
Gentiae Clinical Research June 2005 - May 2006
Gentiae Clinical Research April 2005 - May 2005
Clinimetrics September 2004 - April 2005
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Biopharmaceuticals, Project Management, FDA, Clinical Development, Process Improvement, Business Strategy, Clinical Trials, Commercialization, Drug Development, Leadership
Education
Carnegie Mellon University 2010 — 2012
Master of Business Administration (MBA), Track - Management of Innovation and Product Development, Concentrations - Marketing, Organizational Behavior
University of Southern California 2000 — 2004
BS, Kinesiology
Menlo School
Exelixis February 2012 - Present
DSP Clinical June 2011 - December 2011
BioMarin December 2010 - June 2011
Array BioPharma November 2008 - January 2010
Cell Genesys May 2008 - October 2008
Gentiae Clinical Research February 2007 - August 2007
Keryx Biopharmaceuticals June 2006 - February 2007
Skills
EDC, Clinical Trials, Data Management, Quality Assurance, Clinical, CRO, Clinical Data Management, Clinical Research, GCP, Medidata, Protocol, Validation, Drug Development, Sop, CRF design, Clinical Development, SOP
Education
San Francisco State University 2008 — 2010
B.A., Japanese
City College of San Francisco 2005 — 2008
A.A., Japanese and Asian Studies
Division of Pediatric Critical Care September 2007 - Present
PEGUS Research 2006 - 2007
Novacea 2005 - 2006
Gentiae Clinical Research January 2003 - October 2005
Clinimetrics 2003 - 2003
AAI Pharma 2001 - 2002
Skills
Data Validation, Protocol Development, Database Design, EDC, Data Management, Protocol, Clinical Data Management, Validation, Sop, Computer System..., Clinical Data, Clinical Trials, Clinical Development, ICH-GCP, Clinical Study Design, SOP, GCP, CTMS
Education
University of California Extension, Santa Cruz 1998 — 1999
Certificate, Clinical Trials Design and Management
University of California, Santa Cruz 1995 — 1997
BA, Biology
AHS
Genentech May 2012 - Present
Synarc Inc. September 2007 - May 2012
Gentiae Clinical Research May 2007 - July 2007
Gentiae Clinical Research January 2006 - April 2007
Mindjet 2005 - 2005
The Baxley Group 2004 - 2005
Democratic National Committee 2004 - 2004
Skills
Business Development, Negotiation, Marketing Communications, Clinical Trials, Pharmaceutical Industry, Biotechnology, Lifesciences, Clinical Research, Clinical Development, Oncology, New Business Development, CRO, Strategic Planning, EDC, Biopharmaceuticals, FDA, Competitive Analysis, Marketing, GCP, CTMS, Outsourcing, Contract Negotiation, Cross-functional Team..., Contract Management, Market Research, Salesforce.com, Medical Writing, Medical Devices, Regulatory Affairs, Cardiology, Pharmacovigilance, Life Sciences, Regulatory Submissions
Education
Uppsala University 2003 — 2004
MA
University of California, Berkeley 1999 — 2003
BA
San Francisco University High School 1995 — 1999
KDBS 1991 — 1995
Onyx Pharmaceuticals November 2014 - Present
Real Staffing April 2014 - September 2014
Aerotek September 2013 - April 2014
Genentech, Inc. June 2012 - August 2013
Kelly Services October 2011 - June 2012
Baxter BioScience December 2010 - November 2011
Atribord & Associés May 2010 - December 2010
Genentech February 2007 - June 2009
Almac Group November 2005 - December 2006
Gentiae Clinical Research 2003 - 2005
Skills
Oncology, Clinical Trials, Biotechnology, GCP, CTMS, Clinical Development, Project Management, Budgets, Clinical Research, CRO, FDA, Process Improvement, Drug Development, Sop, Biopharmaceuticals, Neurology, SOP, EDC
Education
International School of Management 2009 — 2012
MBA (In progress), International Business
San Francisco State University 1998 — 2002
BA, English/Creative Writing
Thomas Downey High School
Thomas Downey High School
Lauren Lake Consulting May 2015 - Present
Genentech 2013 - 2015
Genentech, Inc. 2009 - 2012
Genentech 2001 - 2008
Gentiae Clinical Research 1999 - 2000
Kaiser Permanente Center for Health Research 1994 - 1999
Portland Business Journal 1992 - 1994
Mathematica Policy Research 1988 - 1990
Skills
Pharmaceutical Industry, Leadership, Strategic Planning, Data Analysis, Business Intelligence, Design Thinking, Outsourcing, Clinical Trials, Writing, SAS, Drug Development, Strategy, Data Management, Statistical Programming, Biotechnology, Management, Statistics, Process Simplification, CRO, Analytics, Data Integration, Programming, CDISC, Analysis, Clinical Research, Workshop Facilitation, Innovation, 21 CFR Part 11, Validation, Data Warehousing, Project Management, Data Mining, GCP, Oncology, Forecasting, Clinical Data Management, FDA, Clinical Development, Life Sciences, Lean Startup, Cross-functional Team..., Process Improvement, SOP, Change Management, Biopharmaceuticals
Education
Syracuse University 2000 — 2001
MA
Carleton College 1984 — 1988
BA
The London School of Economics and Political Science (LSE) 1986 — 1987
General Course
Genentech April 2013 - Present
BioMarin December 2012 - February 2013
The Sports Club/LA 2011 - 2012
Amgen Inc. March 2006 - March 2010
Keryx Biopharmaceuticals August 2005 - March 2006
Gentiae Clinical Research July 2004 - August 2005
QUINTILES STRATEGIC RESEARCH SOLUTIONS June 2002 - June 2004
San Francisco Health Plan June 2000 - March 2002
Skills
Clinical Trials, CTMS, GCP, CRO, Oracle Clinical, Validation, EDC, Oncology, Data Management
Education
Laney College 1990 — 1992
Social Sciences
AMA
AMA
AMA
AMA
AMA
University of California, Davis
coursework taken towards a degree in Dietetics
Nektar Therapeutics March 2015 - Present
BioClinica March 2014 - February 2015
Synarc July 2010 - March 2014
ARYx Therapeutics May 2008 - August 2010
ARYx Therapeutics May 2007 - May 2008
Gentiae Clinical Research November 2006 - July 2007
Gentiae Clinical Research June 2005 - November 2006
Gentiae Clinical Research September 2003 - June 2005
Gentiae Clinical Research May 2001 - September 2003
Ischemia Research and Education Foundation March 1990 - May 2001
Skills
Clinical Trials, Protocol, CRO, Pharmaceutical Industry, CTMS, Sop, EDC, Drug Development, Medical Devices, Clinical Development, Therapeutic Areas, Cross-functional Team..., Biotechnology, Data Analysis, Clinical Research, Pharmacology, Clinical Operations, ICH-GCP, Lifesciences, Clinical Monitoring, Clinical Study Design, Pharmacovigilance, Neurology, Infectious Diseases, Biomarkers, Medicine, Endocrinology, Internal Medicine, Project Management, Vaccines, FDA, Oncology, Regulatory Affairs, Data Management, Cardiology, Pediatrics, Medical Writing, Clinical Data Management, 21 CFR Part 11, Regulatory Submissions, Informatics, Research, Diabetes, Gastroenterology, Immunology, GCP
Education
Jagiellonian University 1976 — 1982
MD, Medicine
L M Whitney & Associates July 2006 - Present
Ziegler Wealth Management 2005 - 2006
American Express Financial Advisors 2004 - 2005
Gentiae Clinical Research 2000 - 2004
Whitney Roberts Travel of San Francisco 1996 - 2000
Western College of Travel 1994 - 1996
Imported Creations 1969 - 1994
Department of State & Defense 1967 - 1969
Peace Corps 1964 - 1966
Skills
Small Business, Leadership, Strategic Planning, Cultural Sensitivity, Cosmopolitan, Insurance, Negotiation, Finance, Project Management, Process Improvement, Public Speaking, Innovation, Budgets, Financial Analysis, Investments, Creative, Innovative Thinker, Patient
Education
University of Chile 1970 — 1971
post grad, Political Science and International Relations
Drury University
B.A., Sociology, Psychology
Duke University
Psychology
Minnetonka High School
California Department of Public Health February 2015 - Present
United States Air Force May 2010 - December 2014
University of San Francisco School of Law February 2010 - May 2010
Office of the Attorney General, California January 2009 - April 2009
California Supreme Court September 2008 - December 2008
Thelen LLP June 2008 - July 2008
Gentiae Clinical Research July 2004 - May 2006
Skills
Legal Research, Legal Writing, Litigation, Criminal Law, Courts, Civil Litigation, Employment Law, Trials, Westlaw, Mediation, Appeals, Corporate Law, Intellectual Property, Legal Assistance, Commercial Litigation, Research, Criminal Defense
Education
University of San Francisco School of Law 2006 — 2009
Juris Doctor (J.D.), Cum laude, 3.5
University of Michigan 1999 — 2003
Bachelor's Degree, Economics, 3.6
Almac Clinical Technologies March 2015 - Present
Amgen September 2012 - March 2015
Almac Clinical Technologies October 2008 - September 2012
Almac Clinical Technologies May 2006 - September 2008
Gentiae Clinical Research August 2004 - May 2006
Nektar Therapeutics May 2004 - August 2004
Oregon Health & Sciences University February 1999 - February 2004
Skills
EDC, CRO, Clinical Data Management, Clinical Trials, Biotechnology, Sop, Validation, Oncology, Pharmaceutical Industry, Data Management, Clinical Research, Clinical Development, CTMS, 21 CFR Part 11, Computer System...
Education
Portland State University 1997 — 2002
B.S., Biochemistry
Puma Biotechnology, Inc September 2013 - Present
Covance April 2011 - June 2013
Genentech (through Integrated Project Management) August 2010 - February 2011
FibroGen, Inc. April 2008 - February 2010
CV Therapeutics (acquired by Gilead Sciences) May 2006 - April 2008
Actavis Pharma (formerly Watson Pharmaceuticals) January 2003 - April 2006
Gentiae Clinical Research February 2000 - December 2002
Hoechst, Bayer & Wyeth 1989 - 1998
District Department of Health 1988 - 1998
Skills
Clinical Development, Biotechnology, Clinical Trials, Pharmaceutical Industry, Drug Development, CRO, Project Management, Program Management, GCP, Cross-functional Team..., Clinical Research, Oncology, FDA, Validation, GMP, Technology Transfer, Regulatory Submissions, IND, GxP, V&V, Pharmaceutics, Clinical Monitoring, Protocol, Therapeutic Areas, 21 CFR Part 11, Biopharmaceuticals, Sop, EDC, Change Control, ICH-GCP, Regulatory Affairs, CTMS, Clinical Operations, Lifesciences, Drug Discovery, GLP, Pharmacovigilance, CAPA, Regulatory Requirements, Clinical Study Design, Biologics, Biomarkers, Cancer, SOP, Life Sciences
Education
Universidad del Rosario 1980 — 1986
Doctor of Medicine and Surgery
Colegio San Carlos 1974 — 1980
Bachelor
Premier Research October 2012 - Present
Parexel International April 2012 - October 2012
Impax Laboratories September 2008 - April 2012
DURECT Corporation February 2008 - September 2008
Alza March 2007 - February 2008
Gentiae Clinical Research November 2005 - December 2006
Skills
CDISC, SDTM, Clinical Trials, CRO, Clinical Data Management, Pharmaceutical Industry, SAS programming, SAS, GCP, Clinical Development, Data Management
Education
University of Mysore
Citibank / Citigroup May 2008 - Present
Gentiae Clinical Research October 2000 - May 2008
Gentiae Clinical Research 2002 - 2007
Ischemia Research 2000 - 2007
Skills
Data Management, Visio, Computer System..., 21 CFR Part 11, Windows Server, SharePoint, Pharmaceutical Industry, CRO, Biotechnology, Vendor Management, SDLC, Sop, Clinical Trials, Cross-functional Team..., Validation
Education
San Francisco State University 1994 — 1998
Productive Workplace Systems Inc. 2012 - Present
Myriad RBM, Inc. 2007 - 2012
Hesperion 2007 - 2007
Gentiae Clinical Research 2006 - 2007
MDS Pharma Services 2002 - 2005
Productive Workplace Systems Inc. 2000 - 2002
Kendle International Inc. 1999 - 2000
Covance 1998 - 1999
Covance 1996 - 1998
Productive Workplace Systems Inc. 1991 - 1996
Education
Ohio University
RE/MAX Diamond Realty August 2015 - Present
TDM Consulting Services, LLC February 2013 - Present
BioStorage Technologies, Inc. 2010 - 2012
Omnicare Inc. 2007 - 2010
Gentiae Clinical Research 2006 - 2007
ACM Global Central Laboratory 2004 - 2006
Covance 1992 - 2004
RTI International 1988 - 1992
Skills
Real Estate, Real Estate Transactions, Management, Business Development, Sales, Clinical Trials, CRO, Clinical Development, Oncology, New Business Development, Pharmaceutical Industry, Biotechnology, Strategic Planning, Coaching, Clinical Monitoring, Client Development, Pharmacogenomics, Biobanking, Clinical Laboratory..., Drug Development, Clinical Research, Lifesciences, Biopharmaceuticals, Medical Devices, CTMS, Life Sciences
Education
Central Michigan University 2003 — 2005
Master of Science (M.S.), Health Administration
University of North Carolina at Chapel Hill 1978 — 1983
Bachelor of Science (BS), Public Health
BioMarin Pharmaceutical Inc. January 2015 - Present
BioMarin April 2012 - January 2015
ClinTech 2014 - 2014
Genentech November 2010 - April 2012
Genentech June 2007 - December 2010
Almac Clinical Technologies 2006 - 2007
Gentiae Clinical Research 2002 - 2005
Skills
Validation, Project Management, Testing, Leadership, Pharmaceutics, EDC, Sop, Pharmaceutical Industry, Clinical Data Management, Clinical Trials, Biotechnology, 21 CFR Part 11, CRO, Clinical Development, Oncology, Cross-functional Team..., CTMS, Quality Assurance
Education
Academy of Art University 1994 — 1998
BA, Fine Arts
Genentech, A Member of the Roche Group June 2011 - Present
ThinkOne Biotechnologies May 2007 - September 2011
Genentech 2011 - 2011
ISIS, Inc. October 2007 - April 2010
Health 2.0 Conference October 2007 - October 2009
Sunesis Pharmaceuticals April 2008 - January 2009
CareSeek, Inc. October 2007 - January 2008
Gentiae Clinical Research February 2007 - April 2007
Kaiser Foundation Research Institute May 2005 - February 2007
University of California, San Francisco March 2002 - March 2004
Skills
Data Analysis, FDA, Clinical Data Management, Quality Assurance, Clinical Research, CRO, Data Management, Oncology, Informatics, Epidemiology, Sop, Clinical Study Design, Clinical Trials, CRF design, CTMS
Education
Tulane University 1993 — 2004
MPH, Population Studies
George Mason University 1989 — 1991
B.S. Ed, Community Health Education