PUMA BIOTECHNOLOGY LTD
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PUMA BIOTECHNOLOGY LTD Employees
PUMA BIOTECHNOLOGY LTD November 2014 - Present
Amgen March 2004 - October 2014
Amgen January 2003 - March 2004
Amgen March 2001 - January 2003
Allergan June 2000 - March 2001
Skills
NDA & BLA submissions, Clinical Study Design, Clinical Trials, SAS, Clinical Development, Oncology, CRO, CDISC, Clinical Data Management, Pharmaceutical Industry, Oracle Clinical, CTMS, Biostatistics, Data Management, Therapeutic Areas, Drug Development, Biopharmaceuticals
Education
University of California, Los Angeles
PUMA BIOTECHNOLOGY LTD June 2015 - Present
Puma Biotechnology December 2013 - June 2015
ACX Pacific Northwest, Inc October 2011 - December 2013
ACX Pacific Northwest, Inc May 2009 - October 2011
Process Instruments & Controls, LLC June 2007 - May 2009
Skills
Fixed Assets, General Ledger, Accruals, Journal Entries, Financial Statements, GAAP, Account Reconciliation, Variance Analysis, US GAAP, Bank Reconciliation, Cost Accounting, Financial Accounting, Balance Sheet, Accounts Payable, Accounts Receivable, Accounting, Auditing
Education
California State University-Bakersfield 2007 — 2013
Bachelor of Science (B.S.), Accounting
PUMA BIOTECHNOLOGY LTD September 2015 - Present
Baxalta US Inc. October 2013 - July 2015
Baxter Healthcare April 2011 - October 2013
Amgen January 2010 - December 2010
Valeant Pharmaceuticals June 2007 - December 2008
Omega Massage, Inc. March 2003 - May 2007
Cardiogenesis Corporation January 2002 - March 2006
Comfort Systems USA January 2000 - March 2001
Skills
Forecasting, Vendor Management, Budgets, Clinical Trials, Finance, Project Planning, Management, Process Improvement, Leadership, Strategic Planning, Analysis, Project Management, CTMS, Cross-functional Team..., Team Leadership, CRO, Problem Solving, Accounting, Biotechnology, Financial Analysis, Negotiation, Software Documentation, Clinical Development, GCP, Program Management, Training, Budgeting, Payroll, Planning, Contract Management, Excel, Auditing, Customer Relations, Microsoft Office, Word, Financial Reporting, Contract Negotiation, Customer Service, Strategy, Pharmaceutical Industry, Medical Devices, Sales, Quality Assurance, Sourcing, SOP, FDA, Drug Development, Life Sciences
Education
Boston University
Master's Degree, Project Management
University of Phoenix
Bachelor's Degree, Business Accounting
PUMA BIOTECHNOLOGY LTD April 2015 - Present
Education
University of Southern California
MPH, Biostatistics/Epidemiology
PUMA BIOTECHNOLOGY LTD July 2015 - Present
Puma Biotechnology, Inc. July 2014 - July 2015
Puma Biotechnology, Inc. March 2014 - July 2014
Writing Assistance, Inc March 2014 - June 2014
Jukka Hartikka Consulting September 2013 - June 2014
Vical Inc. January 2012 - August 2013
Vical Inc. January 2007 - December 2011
Vical January 2000 - December 2006
Vical January 1995 - December 2000
Vical May 1992 - December 1994
Skills
Biotechnology, Vaccines, Animal Models, Medical Writing, Research, Product Development, Technology Development, Gene Therapy, Oncology, Infectious Diseases, Pharmaceuticals, Drug Discovery, DNA, Cell Biology, Medical Devices, In Vivo, In Vitro, Neuroscience, Microsoft Office, Pharmaceutical Industry, Immunology, Clinical Development, Clinical Trials, Lifesciences, Biopharmaceuticals, Drug Development, Cancer, GCP, Clinical Research, Publication Planning, Medical Communications, Scientific..., Study Reports, AMA style, Review Articles, Social Media, Facebook, Social Networking, Social Networking Sites, Networking Sites, Googling, PowerPoint, Adobe Acrobat, Microsoft Word, Windows 7, Office 2010, Scientific Papers, Poster Presentations, Scientific Writing, Literature Reviews
Education
University of Miami 1985 — 1988
Ph.D.
1984 — 1988
Ph.D.
University of California San Diego Extension 2012 — 2013
Independent Coursework - Continued Education
American Medical Writers Association (AMWA) Workshops 2012 — 2013
Independent Coursework - Continued Education
Cerulean Pharma, Inc September 2015 - Present
PUMA BIOTECHNOLOGY LTD August 2015 - Present
IGNYTA, Inc. August 2014 - April 2015
Sanofi July 2013 - August 2014
Tokai Pharmaceuticals July 2012 - April 2013
Astra Zeneca July 2009 - July 2012
AstraZeneca July 2008 - July 2009
FDA January 2005 - July 2008
National Cancer Institute June 2006 - June 2008
National Institutes of Health April 2000 - December 2004
Skills
Oncology, Clinical Trials, Cancer, Molecular Biology, Therapeutics, Clinical Research, Regulatory Affairs, Clinical Development, Hematology, Regulatory Submissions, R&D, Diagnostics, FDA, Cancer Research, Biomarkers, Translational Medicine, Pharmaceutical Industry, Medicine, Medical Writing, Infectious Diseases, Neurology, Drug Development, Pharmacovigilance, Drug Discovery, Medical Devices, Medical Education, Therapists, Cardiology, CTMS, GCP, Pharmacology, Lifesciences, Biostatistics, Biotechnology, Immunology, Translational Research, Clinical Pharmacology, Medical Affairs, Informatics, Internal Medicine, CRO, Therapeutic Areas, Vaccines, Life Sciences
Education
Universidad de Buenos Aires / UBA 1982 — 1987
Medical Doctor
PUMA BIOTECHNOLOGY LTD August 2015 - Present
Genentech December 2014 - Present
ZOLL Circulation, Inc. May 2013 - November 2013
SRG Woolf Group for Axogen, Inc March 2013 - September 2013
Clinical Research Organization/Sachdev, Inc. January 2007 - May 2013
Good Samaritan Hospital November 2006 - December 2010
Skills
Clinical Research, Clinical Trials, Nursing, Healthcare, CTMS, Hospitals, Critical Care, CRO, Neurology, FDA, Healthcare Management, Stroke, Patient Safety, IRB, Cardiology, Medical Devices, Protocol, Patient Recruitment, Clinical Development, Pediatrics, Scientific Papers, Adult Education, Public Speaking, Performance Improvement, OHRP, NIHSS, ICH-GCP, HIPAA
Education
Evergreen Valley College 1979 — 1981
Associate of Science (A.S.), Registered Nursing/Registered Nurse
PUMA BIOTECHNOLOGY LTD August 2015 - Present
Amgen April 2013 - August 2015
Allergan 2012 - 2013
Pfizer October 2011 - 2012
Novartis July 2010 - June 2011
University at Buffalo July 2009 - June 2011
Pfizer Pharmaceuticals July 2006 - July 2010
Contemporary Health Care Medical Group 2004 - 2005
Prometheus 2003 - 2004
Skills
Molecular Biology, Breast Cancer, Solid Tumor, Pharmacodynamics, Pharmacokinetics, Oncology, Clinical Pharmacology, PK/PD, Clinical Development, Drug Development, Clinical Trials, Drug Metabolism, NONMEM, Translational Research, Biomarkers, Pharmacology, Drug Discovery, Translational Medicine, ADME, Biotechnology, Personalized Medicine, Clinical Study Design
Education
University at Buffalo 2009 — 2011
Postdoctoral Fellowship, Pharmacometrics
University Of California, San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences 2005 — 2009
Pharm D.
California State University-Northridge 1998 — 2003
B.S., Cellular and Molecular Biology
Veristat April 2015 - Present
PUMA BIOTECHNOLOGY LTD December 2014 - April 2015
Exelixis July 2013 - November 2014
Gilead Sciences April 2008 - July 2013
Medtronic Vascular August 2006 - March 2008
Bayer HealthCare March 2006 - August 2006
Skills
Clinical Trials, EDC, Clinical Data Management, Clinical Data, GCP, Medidata, Data Management, CTMS, Oncology, CRF design, Inform, CDISC, Clinical Development, 21 CFR Part 11, CRO
Education
Golden Gate University 2010 — 2012
Master of Business Administration (MBA)
University of California, Berkeley 1998 — 2002
Bachelor of Arts (B.A.), Art History, Criticism and Conservation
PUMA BIOTECHNOLOGY LTD October 2014 - Present
Amgen August 2005 - October 2014
Memorial Sloan-Kettering Cancer Center May 2003 - August 2005
Education
Columbia University in the City of New York 2001 — 2005
PUMA BIOTECHNOLOGY LTD August 2015 - Present
Ardea Biosciences February 2013 - August 2015
Baxter Healthcare August 2008 - February 2013
Baxter Healthcare July 2005 - February 2013
WellPoint April 2003 - July 2005
WellPoint April 2001 - April 2003
Health Net 1995 - 2000
Skills
Vendor Management, Regulatory Affairs, Medical Devices, FDA, Project Planning, Pharmaceutical Industry, Compliance, Cross-functional Team..., GMP, Management, Product Development, Regulatory Requirements, Regulatory Submissions, Sop, Training, Validation, Process Improvement, Quality Assurance, 21 CFR Part 11, Biotechnology
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2000 — 2002
Master of Business Administration (MBA), Business Administration and Management, General
PUMA BIOTECHNOLOGY LTD July 2015 - Present
BioMarin Pharmaceutical Inc. August 2014 - Present
BioMarin March 2013 - July 2014
BioMarin December 2010 - February 2013
Gilead Sciences March 2007 - November 2010
Gilead Sciences June 2004 - February 2007
DANR Analytical Lab 2002 - 2004
Dr. Kurth's Lab 2002 - 2004
Signature BioScience 2002 - 2003
Millenium Pharmaceuticals 2001 - 2002
Skills
Quality Assurance, Biotechnology, Manufacturing, GMP, Product Development, Validation, Supply Chain, Chemistry, FDA, Pharmaceutical Industry, Technology Transfer, Biopharmaceuticals, Contract Manufacturing
Education
Golden Gate University 2008 — 2010
MBA
University of California, Davis 1999 — 2004
B.S Chemistry and B.S. biotechnology
PUMA BIOTECHNOLOGY LTD March 2012 - Present
Gilead Sciences May 2011 - March 2012
Medtronic November 2007 - May 2011
UC Davis 2005 - 2005
National Taiwan University 2004 - 2004
Skills
Project Management, Data Management, Vendor Management, Database Design, CRF design, User Acceptance Testing, Hepatitis, Diabetes, Pharmaceuticals, Data Transfer, Data Validation, Medical Devices, CTMS, Inform, Pharmaceutical Industry, Oracle Clinical, Clinical Trials
Education
University of California, Davis
BS, Biological Systems Engineering
University of California, Davis
Minor, Communications
Puma Biotechnology December 2013 - Present
PUMA BIOTECHNOLOGY LTD November 2012 - December 2013
PwC January 2011 - October 2012
New Mexico State University June 2010 - December 2010
Crestline Building Corporation September 2005 - December 2010
Skills
Microsoft Office, German, Hard Worker, Microsoft Excel, PowerPoint, Microsoft Word, Research, Time Management, Leadership, Accounting, Financial Reporting, English, Financial Analysis
Education
New Mexico State University 2010 — 2011
Master of Accountancy, Accounting
New Mexico State University 2005 — 2011
Bachelor of Business Administration, International Business