Affymax, Inc.
Industry: Company
DescriptionHeadquarters: Cupertino, CA Founded: 2001
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Affymax, Inc. Employees
Fresenius Medical Care April 2013 - February 2014
Affymax Inc. April 2012 - March 2013
AMAG Pharmaceuticals, Inc August 2008 - April 2012
EMD Serono, Inc. January 2008 - August 2008
Ortho Biotech Products September 2002 - December 2007
Innovex Inc. June 2001 - September 2002
Fresenius Medical Care January 2001 - June 2001
DaVita September 1994 - January 2001
Skills
Hematology, Nephrology, Hospital Sales, Nursing, Injectables, Medical Devices, Injectable, Managed Care, Hospitals, Dialysis, Buy & Bill, Product Launch, Oncology, Clinical Research, Biotechnology, Rheumatology, Endocrinology, Pharmaceutical Sales, Biopharmaceuticals, Sales Operations, Diabetes, Cardiology, Urology, Primary Care, Neurology, Gastroenterology, Dermatology, OB/GYN, Pulmonology, Sales Effectiveness, Pharmaceutical Industry
Education
Wilmington College 1998 — 2000
Masters, Business Administration
HAHNEMANN UNIVERSITY 1991 — 1993
Associate, Nursing Program
Temple University 1987 — 1991
BS, Exercise Physiology
Bioorganic Chemistry Consulting June 2013 - October 2013
Pfizer January 2012 - May 2013
Pfizer January 2008 - December 2011
CovX July 2006 - December 2007
CovX February 2005 - June 2006
Gryphon Therapeutics July 2002 - November 2004
Affymax, Inc. July 2001 - July 2002
GlaxoSmithKline July 1996 - July 2001
Affymax Research Institute January 1993 - July 1996
Skills
Peptides, Peptide Synthesis, Medicinal Chemistry, Conjugation, Technology Transfer, Pharmaceutical Industry, CMC, CMO management, IND, Biotechnology, Drug Discovery, Oncology, Chemistry, Lead Change, Clinical Development, GMP, In Vitro, Small Molecules, Antibodies, R&D, Parallel Synthesis, Regulatory Submissions, Drug Development
Education
The University of Edinburgh 1989 — 1993
Ph.D., Organic Chemistry
Queen's University Belfast
BSc, Biochemistry
Allergan February 2014 - Present
Allergan March 2012 - February 2014
Allergan January 2012 - March 2012
Watson Pharmaceuticals, Inc. June 2011 - January 2012
Allergan, Inc March 2011 - June 2011
Gilead Sciences, Inc. September 2010 - December 2010
Affymax, Inc. November 2009 - May 2010
SciClone Pharmaceuticals, Inc. April 2006 - November 2009
Amylin Pharmaceuticals, Inc. September 2005 - December 2005
Integrium, LLC July 2004 - September 2005
Skills
GCP, Pharmacovigilance, Clinical Trials, Sop, FDA, CRO, MedDRA, EDC, Clinical Study Design, Protocol, Validation, System Administration, PowerPoint, 21 CFR Part 11, Outlook, Computer System..., Medical Devices, Infectious Diseases, Manuals, Mentoring, Scripting, Installations, Business Requirements, Excel, Word, Process Validation, Guides, Microsoft Office, Visio, Visual Basic, SQL, Windows, VBScript, Documentation, Business Objects, Salesforce.com, Oracle Argus, ClinTrace, ARISg, Liquent Regulatory..., MS Access (RDBMS), DSNavigator, Documentum, FirstDoc, SOP, Pharmaceutical Industry
Education
University of California, Los Angeles 1999 — 2002
BA, Psychology
Biola University
Bayer HealthCare July 2013 - Present
Affymax, Inc April 2012 - May 2013
Genentech August 2003 - April 2012
Bone Care International December 2000 - August 2003
Skills
Biotechnology..., Nephrology, Stroke, Neurology, Retina, Oncology, Product Launch, Buy and Bill Model
Education
Pennsylvania State University, University Park, PA 1976 — 1980
Bachelor of Science (BS), Psychology
SUNY Empire State College 1998 — 2000
Master's degree, Business Policy & Studies
NY College of Podiatric Medicine 1980 — 1984
Doctor of Podiatric Medicine, Podiatric Medicine and Surgery - 24 Residency Program
Alexza Pharmaceuticals January 2015 - Present
Gilead Sciences 2013 - November 2014
Infinity Pharmaceuticals 2011 - 2013
Affymax, Inc. 2002 - 2011
Affymax Research Institute, GlaxoSmithKline 2000 - 2002
AstraZeneca 1998 - 2000
Archer Daniels Midland Company 1995 - 1998
University of California, San Francisco 1994 - 1995
Skills
Peptides, Problem Solving, HPLC, GMP, Mass Spectrometry, Pharmaceutical..., Analytical Chemistry, LC-MS, Pharmaceuticals, Chemistry, Chromatography, Biotechnology, Validation, Drug Discovery, NMR, Formulation Development, Characterization, Regulatory Submissions, R&D, Protein Purification, Purification, IR, Product Development, Pharmaceutical Industry, Oncology, Formulation, Drug Development, FDA, Protein Chemistry, Pharmaceutics, IND, Technology Transfer, Biopharmaceuticals, CMC, Medicinal Chemistry, CRO, Clinical Development, NDA, Organic Chemistry, Sop, Lifesciences, Assay Development, Life Sciences
Education
University of Illinois at Urbana-Champaign
Doctor of Philosophy (Ph.D.), Chemistry
Protagonist Therapeutics April 2013 - June 2014
Affymax, Inc. 2012 - March 2013
Affymax, Inc. 2006 - 2011
Affymax, Inc. 2002 - 2005
Affymax Research Institute / GlaxoSmithKline 2000 - 2002
Purdue University 1996 - 2000
Skills
Pharmaceutical process..., Manufacturing, Small molecule drug..., API manufacturing, Medicinal Chemistry, PEGylation, Peptide drug discovery, Peptide drug dilivery, Drug substance, Organometallic Chemistry, Peptide Synthesis, Cross Coupling reactions, Palladium chemistry, HPLC, LC/MS, LC/MS/MS, NMR spectroscopy, GLP, cGMP, Process change control, Process validation
Education
Purdue University 1996 — 2001
Doctor of Philosophy (Ph.D.), Organic Chemistry, 4.0
Regeneron Pharmaceuticals, Inc. June 2014 - Present
Jazz Pharmaceuticals May 2013 - Present
Affymax Inc. May 2012 - May 2013
Novartis March 2009 - May 2012
Novartis US Medical August 2006 - March 2009
Texas Tech University June 2001 - August 2006
El Paso Times August 1999 - August 2006
TENET Healthcare: Sierra Medical Center, El Paso, TX June 1999 - August 2006
University of Texas at Austin/University of Texas at El Paso Cooperative Pharmacy Program July 1997 - July 1999
San Jacinto Methodist Hospital, Baytown, TX May 1991 - July 1996
Skills
Medical Affairs, Clinical Research, Clinical Development, Nephrology, Neurology, Pharmacovigilance, Healthcare, Endocrinology, Diabetes, Osteoporosis, Immunology, Health Economics, Infectious Diseases, Dermatology, CTMS, Pharmacology, Therapeutic Areas, Urology, Transplant, Pharmacists, Pharmaceutical Sales, Pharmaceutical Industry, Rheumatology, Oncology, Gastroenterology, Hypertension, Medical Writing, Regulatory Affairs, Biotechnology, Drug Development, Anemia
Education
Providence VA Medical Center/Univ of Rhode Island/Brown Univ.
Post-Doctoral Specialty Residency in Primary Care, Primary Care Pharmacotherapy
Texas Southern University 1992 — 1996
Doctorate, Pharmacy
Texas Southern University 1986 — 1990
BS, Pharmacy
The University of Texas at El Paso
Pre-Pharmacy
ACADIA Pharmaceuticals Inc. June 2015 - Present
Relypsa, Inc. October 2014 - June 2015
Halozyme Therapeutics, Inc. August 2013 - February 2014
Affymax, Inc. January 2012 - June 2013
Amylin Pharmaceuticals November 2002 - December 2011
Amira Medical 1998 - 2002
Safeskin 1996 - 1998
Skills
Pharmaceuticals, Marketing Communications, Event Management, Contract Negotiation, Budgeting, Brand Development, Corporate Communications, Pharmaceutical Industry, Project Management, Sales Operations, Pharmaceutical Sales, Strategic Planning, Product Launch, Biotechnology, Cross-functional Team..., Budgets, Marketing Strategy, Strategy, Managed Care, Endocrinology, Urology, Diabetes, Market Research, Rheumatology, Oncology, Lifesciences, Commercialization, Biopharmaceuticals, Hospital Sales, Cardiology, Gastroenterology, Life Sciences
Education
San Jose State University 2000 — 2002
Bachelor's Degree, Business Administration, Marketing
Dragados USA, Inc. September 2015 - Present
VMC March 2014 - September 2015
Medvice, Inc. March 2013 - August 2013
CYTOKINETICS, INC February 2011 - February 2013
AFFYMAX, INC May 2006 - December 2010
SUCCESSFACTORS, INC October 2005 - March 2006
Intel Corporation July 1999 - March 2005
Rosenbluth International August 1997 - July 1999
NOVELL, INC March 1997 - August 1997
Boole & Babbage June 1983 - November 1996
Skills
Conferences, Outlook, Excel, Scheduling, PowerPoint, Word, Microsoft Office, Event Management, Administration, Microsoft Excel, Microsoft Word, Administrative..., Process Scheduler, Event Planning, Research, System Administration, Budgets, Marketing Communications, Marketing, Project Management, Software Documentation, Management, Editing, Teamwork, Customer Service, Strategic Planning, Team Leadership, Biotechnology, GCP, Team Building, CRO, Healthcare, Databases, Sop, Access, Clinical Trials, Program Management, Project Planning, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, FDA, Oncology, CTMS, Lifesciences, Data Management, EDC, Data Analysis, Infectious Diseases, Medical Devices
Education
San Jose State University 1993 — 1995
Certificate, Marketing Communications
Dynavax Technologies July 2014 - Present
Dynavax Technologies February 2013 - June 2014
Affymax Inc. 2007 - 2011
National Institutes of Health 2004 - 2006
Drexel University 1999 - 2004
Skills
Biotechnology, HPLC, FDA, Technology Transfer, Chromatography, GLP, GMP, Cell Culture, Assay Development, Lifesciences, Clinical Development, Biopharmaceuticals, Drug Development, Purification, Validation
Education
Drexel University 1999 — 2004
Ph.D., Chemical & Biological Enginering
Osmania University 1995 — 1999
B.S., Chemical Engineering
Heron Therapeutics, Inc. May 2014 - Present
Heron Therapeutics, Inc. May 2014 - Present
Affymax, Inc August 2011 - December 2012
Cordis Corporation October 2007 - August 2011
Nektar Thearapeutics March 2005 - May 2007
ALZA Corporation June 2000 - March 2004
LifeScan April 1998 - May 2000
Skills
Analytical Chemistry, GMP, Drug Delivery, HPLC, GLP, Validation, Sop, LIMS, V&V, FDA, Change Control
Education
De Anza College 1996 — 1997
Certificate of Achievement, Biotechnology
Ramnarain Ruia College, Bombay, India 1992 — 1993
Diploma, Industrial Analytical Chemistry
Kanpur University
M.Sc., Physical Chemistry
Healthways 2015 - Present
FUSION BEATZ 2013 - Present
Quest life sciences Pvt. Ltd. December 2010 - 2012
Affymax, Inc. 2000 - 2003
Genome Therapeutics Corp. January 1999 - May 2000
St. Jude Children's Research Hospital March 1997 - December 1998
Skills
Oncology, Lifesciences, Clinical Trials, Pharmaceutical Industry, GCP, CRO
Education
UC Irvine Extension 2009 — 2010
Certificate, Regulatory Affairs
The University of Memphis 1996 — 1998
M.S., Biology
Bombay College of Pharmacy 1990 — 1994
B. Pharm, Pharmaceutical Sciences
Exelixis June 2011 - Present
Price Watkins Media Inc May 2011 - July 2013
Affymax, Inc. September 2009 - April 2011
Elan Pharmaceuticals, Inc. April 2007 - August 2009
Elan Pharma Ltd 2003 - April 2007
GlaxoSmithKline 1996 - 2002
CRC Technology Limited 1994 - 1995
Institute of Child Health 1993 - 1994
Charing Cross Hospital Medical School 1989 - 1992
Aston University 1986 - 1989
Skills
Medical Writing, Clinical Research, Leadership, Clinical Development, Biotechnology, Oncology, Pharmaceutical Industry, Clinical Trials, Drug Discovery, CRO, GCP, Lifesciences, Infectious Diseases, Drug Development, Research, Regulatory Submissions, Life Sciences, Sop, FDA
Education
University of Manchester - Institute of Science and Technology
Doctor of Philosophy (PhD)
University of Manchester - Institute of Science and Technology
Bachelor of Science (BSc)
Monsanto Company April 2014 - Present
Freelancer November 2013 - April 2014
Affymax, Inc. October 2000 - April 2013
Skills
HPLC, LC-MS, Drug Discovery, Organic Chemistry, Purification, Biotechnology, IND, NMR, Medicinal Chemistry, NDA, Peptide..., Reference material..., CMC knowledge, Peptide Synthesis, Patent searching and..., ELISA, Due Diligence, Patents, Chemistry, Formulation, Peptides
Education
Cornell University 1997 — 1999
Postdoctoral Research, Drug Designs
Rutgers University-New Brunswick 1992 — 1997
Ph.D., Synthetic organic chemistry
PLI
Fresenius Medical Care May 2014 - Present
Mar Cor Purification August 2013 - May 2014
Affymax, Inc. April 2012 - April 2013
AMAG Pharmaceuticals September 2010 - April 2012
Actavis September 2001 - September 2010
Skills
Sales, Product Launch, Sales Process, Salesforce.com, Pharmaceutical Sales, Biotechnology, Marketing Strategy, Product Marketing, Medical Devices, Buy & Bill, Nephrology, Urology, Hospitals, Endocrinology, Cardiology, Oncology, Hematology, Internal Medicine, Sales Operations, Selling Skills, Therapeutic Areas, Orthopedic, OB/GYN, Clinical Research, Pulmonology, Pain Management, Gastroenterology, Hospital Sales
Education
Ball State University - College of Business
Bachelor of Science (BS), Marketing
Indiana Wesleyan University
Master of Business Administration (MBA)
Gilead Sciences April 2013 - Present
Affymax, Inc. February 2010 - April 2013
Gilead Sciences 2009 - 2010
CV Therapeutics May 1999 - March 2009
Genentech 1984 - 1999
Skills
Statistical Programming, Biotechnology, Clinical Development, Clinical Trials, Drug Development, Pharmaceutical Industry, FDA, Lifesciences, CRO, 21 CFR Part 11, Validation
Education
University of California, Berkeley 1979 — 1981
B.S., Chemical Engineering
University of California, Berkeley 1972 — 1976
B.A., Music
Dart Neuroscience January 2011 - Present
AJE - American Journal Experts July 2010 - March 2013
Ligand Pharmaceuticals June 2007 - February 2011
Cropsolution 2004 - 2004
Affymax, Inc. 2002 - 2004
Skills
Medicinal Chemistry, Drug Discovery, HPLC, Organic Chemistry, NMR, Organic Synthesis, Drug Design, LC-MS, Purification, Chromatography, Parallel Synthesis
Education
University of California, San Diego 2005 — 2007
MS, Chemistry
University of California, Davis 2004 — 2005
Chemistry
San Jose State University 1997 — 2002
BS, Chemistry
UL EduNeering January 2015 - Present
UL EduNeering May 2013 - January 2015
Affymax, Inc October 2006 - March 2013
Gilead February 2004 - October 2006
Tercica September 2001 - February 2004
Genentech November 1996 - September 2001
Skills
Clinical Research, FDA, Regulatory Submissions, Biotechnology, IND, Cross-functional Team..., Project Management, Clinical Trials, GLP, Sop, Training, 21 CFR Part 11, CTMS, GMP, Clinical Development, Biopharmaceuticals, Validation, Drug Development, Pharmaceutical Industry, Oncology, Document Management, Lifesciences, CRO, eCTD, Quality System, GCP, Computer System..., GxP, Change Control, EDC, Clinical Data Management, Regulatory Requirements, Regulatory Affairs, Pharmacovigilance, Technology Transfer, Drug Discovery, CAPA, Pharmaceutics, V&V, Medical Devices, Quality Assurance, Commercialization, Data Management, Vaccines, R&D, GAMP, Quality Control, SOP, Life Sciences
Education
Skyline College
University of Phoenix
EpicentRx, Inc. December 2014 - Present
CFLS, LLC March 2009 - Present
Affymax, Inc. October 2007 - February 2009
Coderant, LLC March 2002 - October 2007
Coulter Pharmaceutical, Inc. January 2000 - March 2002
Genentech, Inc. September 1998 - January 2000
The Benham Group, Inc. April 1994 - July 1995
Skills
Legal Advice, Business Strategy, Legal Writing, Team Leadership, Corporate Law, Intellectual Property, Mergers, Management, Litigation, Negotiation, Mergers & Acquisitions, Licensing, Legal Research, Entrepreneurial Finance, Restructuring, Document Management, Corporate Governance, Entrepreneurship, Due Diligence, Legal Assistance, Commercial Litigation, Contract Negotiation, Privacy Law, Legal Compliance, Venture Capital, Private Equity, Employment Law, Employment-based..., Mediation, Arbitration, Strategic Partnerships, 21 CFR Part 11
Education
St. John's University School of Law 1995 — 1998
Juris Doctorate
UCLA 1989 — 1993
Bachelor of Arts, Political Science
Veracyte, Inc. May 2013 - Present
Army National Guard September 1987 - Present
Affymax, Inc. April 2012 - May 2013
Genzyme / Bone Care International July 2004 - April 2012
Johnson & Johnson July 1999 - July 2004
Skills
Biotechnology, Pharmaceutical Industry, Cross-functional Team..., National Account..., Territory Expansion, Business Planning, Business Analysis, Product Launch, Competitive Intelligence, Early-stage Startups, Budget Forecasts, Meeting Planning, International Relations, Team Building, Buy & Bill, Sales Management, Sales, Training
Education
The Citadel 1990 — 1994
Bachelor's degree, Business Administration and Management, General
Irmo High School
Meritech Capital Partners January 2015 - Present
Onyx Pharmaceuticals, (Acquired by Amgen) September 2012 - January 2015
Genomic Health May 2012 - September 2012
SuccessFactors (Acquired by SAP) February 2011 - May 2012
Affymax, Inc. 2010 - 2011
Genentech 2006 - 2010
Connetics Corporation 2003 - 2006
Skills
Outlook, PowerPoint, Microsoft Office, Event Planning, Word, Excel, Member of Toastmasters
Education
College of San Mateo
AA, Liberal Studies
SDL Capital / SDL Ventures November 2013 - April 2014
Venrock February 2007 - June 2013
Apax Partners 2001 - 2006
Affymax, Inc. 2001 - 2001
Telegis Networks 2000 - 2001
Aerial Communications (now T-Mobile) 1995 - 2000
U.S. Cellular 1992 - 1995
Skills
Venture Capital, Heavy Calendaring, Administrative..., Expense Management, High Level Of..., Investor Relations, Coordinating Events, Private Equity, Travel Planning, Start-ups, Event Planning, Outstanding..., PowerPoint, Salesforce.com, Microsoft Office, QuickBooks, Concur
Education
Southern Illinois University, Carbondale
Bachelor of Arts (B.A.)
NxStage Medical June 2013 - Present
Affymax, Inc. April 2012 - March 2013
Amgen October 2009 - December 2011
Roche/Genentech May 2008 - September 2009
North Shore University Health Systems July 2006 - July 2008
North Shore University Health Systems July 2005 - July 2006
Fresenius Medical Care July 2003 - July 2005
Fresenius Medical Care July 2002 - July 2005
Michelle Interiors 1988 - 2002
Education
Loyola University of Chicago
BSN
Harper College 1992 — 1995
The Advisory Board Company January 2014 - Present
(Non-Profit, Social Enterprise, and Healthcare) June 2009 - December 2013
Affymax, Inc. February 2006 - May 2009
Apax Partners July 2000 - May 2003
Needham & Co. June 1998 - May 2000
Skills
Venture Capital, Due Diligence, Healthcare, International..., Biotechnology, MBA, Start-ups, Non-profits, Social Entrepreneurship, BD, Corporate Finance, Financial Analysis, Strategic Planning, Program Management, Nonprofits, Leadership
Education
Stanford University Graduate School of Business 2003 — 2005
MBA
Georgetown University 1994 — 1997
B.A., American Studies
Prothena Biosciences Inc July 2013 - Present
Affymax, Inc. December 2002 - May 2013
LC Packings, A Dionex Company 2001 - 2002
Cooley Godward 2000 - 2001
SUGEN, Inc. 1996 - 2000
Skills
Administrative..., Office Management, Purchasing, Business Planning, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Lifesciences, Microsoft Office, Strategic Planning, Management, Facilities Management, Change Management, Program Management, Contract Negotiation, R&D, Microsoft Excel, Start-ups, Operations Management, Budgets, Leadership, Training, Strategy, Team Leadership, Sop, Biopharmaceuticals, Team Building
Education
Columbia Southern University
Certificate, Industrial Hygiene Management
Columbia Southern University
Certificate, Environmental Management
Columbia Southern University
Master of Science (M.S.), Occupational Health and Safety and Environmental Management
Notre Dame de Namur University
Teaching Credential Courses
University of California, Berkeley
Bachelor of Arts (B.A.), English
Gilead Sciences January 2013 - Present
Gilead Sciences December 2010 - December 2012
Affymax, Inc. September 2008 - December 2010
Affymax, Inc. March 2007 - August 2008
Affymax, Inc. January 2006 - March 2007
Affymax, Inc. January 2003 - December 2005
Affymax, Inc. July 2000 - December 2002
Anaspec, Inc. June 1998 - June 2000
Skills
Clinical Trials, Biotechnology
Education
California State University-East Bay 2002 — 2005
MS
San Jose State University 1993 — 1999
BS
Tonix Pharmaceuticals 2014 - Present
FibroGen 2011 - 2014
Proteolix June 2009 - April 2010
Affymax, Inc. 2000 - 2009
Skills
Biotechnology, Clinical Trials
Education
University of California, San Diego
QPS, LLC February 2014 - Present
Ricerca Biosciences February 2011 - February 2014
Affymax January 2009 - October 2010
Affymax Inc. July 2007 - January 2009
QLT Inc. January 2000 - June 2007
Skills
GLP, Toxicology, IND, Clinical Development, Drug Discovery, Interpersonal Skill, Pharmaceutical Industry, Pharmacology, FDA, Drug Development, Biopharmaceuticals, Maintaining Strong..., Regulatory Submissions, Pharmacokinetics, Bioanalysis, Regulatory Affairs, CRO, Sop, Lifesciences, In Vitro, Biotechnology, DMPK
Education
Diplomate American Board of Toxicology 2006 — 2006
DABT
Queen's University 1993 — 1995
MSc., Pharmacology and Toxicology
Queen's University 1989 — 1993
BSc.H, Life Sciences
Relypsa, Inc. February 2015 - Present
Relypsa, Inc. May 2013 - Present
Affymax, Inc. February 2013 - April 2013
Affymax, Inc. January 2011 - January 2013
Affymax April 2008 - December 2010
Affymax January 2007 - March 2008
Affymax October 2005 - December 2006
Affymax January 2003 - October 2005
Affymax Inc. December 2000 - January 2003
Skills
Biotechnology, FDA, Clinical Trials, Pharmaceutical Industry, IND, Regulatory Affairs, Drug Discovery, NDA, Clinical Development, Clinical Research
Education
Boston University 1995 — 2000
BA/MA, Chemistry
Warwick Elementary School August 2011 - Present
none February 2010 - May 2010
Affymax, Inc. May 2004 - April 2007
Affymax 2004 - 2007
InterMune, Inc. June 1998 - December 2003
InterMune, Inc. 1998 - 2003
Fresenius/Spectra Renal Management 1996 - 1998
Fresenius Medical Care 1996 - 1998
Stanford University Hospital 1985 - 1990
Syva July 1981 - June 1984
Skills
Marketing Management, Cross-functional Team..., Business Development, Clinical Development, Product Development, Product Management, Strategic Planning, Strategy, Event Planning, Project Planning, Corporate Development, Market Research, Positioning, Product Marketing, Management, Start-ups, Global Marketing
Education
San Francisco State University 2009 — 2010
Teaching Credential, Secondary Education: Biological Sciences and Geosciences, K-12
San Jose State University 1981 — 1984
MBA, Marketing
San Francisco State University
Biology/Microbiology
Affymax, Inc. 2001 - 2013
Affymax Research Institute, a wholly owned subsidiary of the Glaxo-Wellcome Group 1995 - 2000
Skills
Drug Discovery, Purification, Protein Chemistry, Peptides, ELISA, Cell Culture, Chromatography, Flow Cytometry, Radiation Safety, Cell, Biotechnology, Drug Development, Assay Development, High Throughput..., Biochemistry, Immunology, Antibodies, Molecular Biology, In Vitro, HPLC, Biopharmaceuticals, LC-MS, GLP, Biomarkers, Fluorescence, FPLC, IND, Transfection, Project Management, EH&S Compliance, Cross-functional Team..., Cell Based Assays, Lead Optimization, Compound Screening, New Technology..., CRO, GMP, FDA, Bioanalysis, R&D, Chemistry, Monoclonal Antibodies
Education
San Jose State University
Bachelor of Arts (B.A.), Zoology/Animal Biology
Relypsa, Inc. February 2014 - Present
Relypsa, Inc. July 2013 - February 2014
Affymax August 2012 - May 2013
Affymax, Inc. July 2009 - August 2012
Impax Pharmaceuticals, Inc February 2008 - July 2009
Abbott Vascular January 2006 - December 2007
ALZA Corporation May 2004 - December 2005
Pharmacia January 2000 - May 2004
Searle January 1997 - May 2004
Abbott Laboratories September 1991 - January 1997
Skills
Clinical Trials, 21 CFR Part 11, CDISC, GCP, Validation, Pharmaceutical Industry, SAS programming, Biotechnology, Clinical Development, FDA, SAS, Clinical Data Management, EDC
Education
Northern Illinois University 1988 — 1990
M.S., Applied Probability and Statistics
Independent Statistical Consultant June 2013 - Present
Affymax, Inc. April 2008 - May 2013
ICON Clinical Research January 2000 - 2008
Pacific Research Associates November 1994 - January 2000
Syntex Laboratories, Inc. September 1986 - September 1994
Skills
Clinical Trials, Data Management, CRO, Clinical Development, Biostatistics, Biotechnology, Integration, Lifesciences, EDC, GCP, FDA, Pharmaceutical Industry, Clinical Research, Drug Development, CTMS, Medical Devices, Protocol, Statistics, Drug Discovery, Regulatory Submissions, Oncology, Biopharmaceuticals, 21 CFR Part 11, Sop, Therapeutic Areas, Infectious Diseases, Pharmacovigilance, Medical Affairs, Medical Writing, Regulatory Affairs, CDISC, Life Sciences, SOP
Education
Iowa State University
Doctor of Philosophy (Ph.D.), Statistics
Western Washington University
Master of Science (MS), Psychology
Pharmacyclics October 2013 - Present
Portola Pharmaceuticals July 2012 - Present
Ipsen U.S., Inc. June 2007 - June 2012
Ipsen June 2007 - June 2012
Ipsen 2007 - June 2012
Affymax Inc. 2006 - 2007
NeurogesX 2004 - 2006
Scios Inc. (Johnson & Johnson company) 2001 - 2004
Roche Pharmaceuticals April 1999 - November 2001
ALZA Corporation, Palo Alto, CA 1996 - 1998
Skills
Logistic Regression, Clinical Development, CRO, Clinical Trials, Drug Development, Oncology, Biostatistics, Clinical Data Management, Clinical Research, FDA, Protocol, Regulatory Submissions, Sop, Clinical Study Design, Biotechnology, Statistics, Pharmaceutical Industry, EDC, Data Management, Endocrinology, Therapeutic Areas, Medical Affairs, GCP, Pharmacology, CTMS, CDISC, Medical Writing, IND, Infectious Diseases, Vaccines, SOP
Education
Iowa State University
M.S., Ph.D., Statistics
Minnesota State University, Mankato
M.A., Math/Computer Science
Tamkang University
B.S., Math
Coherus Biosciences February 2015 - Present
Intermune Inc. May 2013 - January 2015
Affymax, Inc January 2008 - May 2013
Boston Scientific Inc. May 2005 - December 2007
ICON Clinical Research November 2001 - May 2005
Roche Pharmaceuticals 1993 - 2001
Skills
Biostatistics, Clinical Development, Clinical Trials, Biotechnology, Oncology, CRO, EDC, GCP, FDA, Pharmaceutical Industry, Infectious Diseases, Clinical Data Management, Regulatory Submissions, Lifesciences, CDISC
Education
University of California, Los Angeles 1991 — 1993
Master of Science (MS), Biostatistics, School of Public Health
UCSF August 2015 - Present
Threshold Pharmaceuticals February 2014 - April 2015
Guided Delivery Systems, Inc. April 2013 - January 2014
Affymax, Inc. August 2012 - March 2013
ProTrials Research September 2011 - November 2012
Affymax October 2008 - September 2011
Ventus Medical May 2008 - September 2008
FoxHollow Division, Ev3, Inc. November 2007 - May 2008
FoxHollow Division, Ev3, Inc. January 2007 - October 2007
Sara L. Colby, MD & Assoc. April 2004 - December 2006
Skills
Clinical Trials, Clinical Research, Clinical Development, Dermatology, CRO, CTMS, EDC, FDA, GCP, Management, Medical Devices, Medicine, Surgery, Clinical Monitoring, Oncology
Education
Brandman University, Part of the Chapman University System 2013 — 2018
Bachelor’s Degree
University of California, Santa Cruz 2007 — 2009
Clinical Research
De Anza College 2004 — 2009
AA, Liberal Arts, Social & Behavorial Sciences Emphasis
Cytokinetics, Inc. June 2015 - Present
InterMune, Inc. April 2014 - May 2015
Affymax, Inc. September 2007 - May 2013
Connetics Corporation October 2001 - August 2007
Endwave Corporation December 2000 - September 2001
Skills
Licensing, Biotechnology, Clinical Development, Due Diligence, Pharmaceutical Industry, Contract Management, Contract Negotiation, Cross-functional Team..., Clinical Trials, Legal Writing, Business Development, Mergers & Acquisitions, Healthcare, Corporate Law, Commercialization, HIPAA, Privacy, Privacy Law, Lifesciences, Regulatory Affairs, Technology Transfer, Sop, Intellectual Property, Medical Devices, Biopharmaceuticals, Life Sciences, CRO, Clinical Research, Conflict Resolution, Conflict Management, FDA, Project Management, SOP
Education
Loyola Law School, Los Angeles 1997 — 2000
JD, Law
Boston University 1996 — 1997
MA, International Relations
Emerson College 1993 — 1995
MA, Communications: Marketing & Advertising
Notre Dame de Namur University 1989 — 1993
BA, Communications
Amgen October 2006 - Present
Avidia, Inc. October 2003 - October 2006
Affymax, Inc. January 2000 - October 2003
Skills
Assay Development, Biochemistry, Biopharmaceuticals, Biotechnology, Cell Biology, Cell Culture, Drug Discovery, High Throughput..., ELISA, Life Sciences, Lifesciences, Protein Chemistry, Molecular Biology, Phage Display
Education
California Polytechnic State University-San Luis Obispo 1995 — 1999
B.S., Biology, Psychology
Alexza Pharmaceuticals August 2005 - Present
Affymax, Inc. 1996 - 2004
Zoecon/Sandoz 1989 - 1996
Education
University of San Francisco 1991 — 1993
MS, Environmental Management
San Jose State University 1986 — 1991
BS, Biology
Teikoku Pharma USA March 2007 - Present
Affymax Inc 1997 - 2001
Education
Michigan State University 1982 — 1987
Puma Biotechnologies April 2014 - Present
Elan Pharmaceuticals January 2012 - Present
Independent Records/Document Management Consultant April 2013 - March 2014
Oxigene, Inc September 2011 - November 2011
Affymax, Inc. April 2009 - August 2011
Oracle October 2008 - April 2009
Abbott Vascular March 2008 - September 2008
Alza Corporation November 2006 - December 2007
Scios 2005 - 2006
Fireside Bank November 2003 - May 2005
Skills
Sop, GCP, Clinical Trials, FDA, Biotechnology, CTMS, 21 CFR Part 11, Document Management, Regulatory Affairs, EDC, CRO, Clinical Development, Oncology, Validation, Pharmaceutical Industry, Records Management, Clinical Data Management, Software Documentation, Quality Assurance, Clinical Research, Change Control, Computer System..., GxP, CAPA, GMP, Regulatory Submissions, LIMS, Data Management, Drug Development, Medical Devices, GLP, Lifesciences, Protocol, CDISC, Pharmacovigilance
Education
Foothill College
AA, Music Theory and Composition
Dermira, Inc. February 2014 - Present
Self Employed, Biopharmaceutical Industry July 2013 - February 2014
Affymax, Inc. January 2013 - May 2013
Affymax, Inc. December 2011 - December 2012
Affymax, Inc. July 2007 - November 2011
Affymax October 2004 - June 2007
Genitope 2002 - 2005
Roche Global Development 1997 - 2002
Roche Pharmaceuticals 1997 - 2001
Syntex Laboratories 1989 - 1995
Skills
GCP, Quality Assurance, Clinical Development, IND, Biotechnology, Clinical Trials, Regulatory Submissions, FDA, Regulatory Affairs, Pharmaceutical Industry, Sop, Biopharmaceuticals
Education
The University of Kansas 1995 — 1996
PharmD, Pharmacy
University of Colorado Boulder 1981 — 1985
BS, Pharmacy
Advanced Clinical (contract) April 2013 - Present
Affymax, Inc. February 2013 - March 2013
Affymax, Inc. June 2010 - January 2013
Affymax, Inc. September 2008 - May 2010
Abbott Vascular February 2007 - September 2008
Aris Clinical, Inc. January 2006 - January 2007
Aris Clinical, Inc. January 2004 - December 2005
Aris Clinical, Inc. March 2002 - January 2004
Aris Clinical, Inc. February 2001 - February 2002
Skills
Clinical Trials, EDC, Clinical Operations, Clinical Monitoring, Trial Master Files, Rescue Studies, Regulatory Operations, Document Publishing, Document Management, SOP Development, SOP Authoring, FDA Inspections, Medical Devices, EDMS, LMS, CRO, FDA, Biotechnology, GCP, SOP development, SOP authoring, Drug Discovery
Education
State University of New York College at Geneseo
BA, Psychology
Quintiles October 2011 - Present
Affymax, Inc. February 2008 - September 2011
FoxHollow Technologies 2006 - 2008
Guidant 2004 - 2006
Skills
CTMS, Clinical Development, GCP, CRO, Biotechnology, FDA, EDC, Clinical Monitoring, Sop, Clinical Research, Pharmaceutical Industry, Medical Devices, Cardiology, Protocol, GMP
Education
California Polytechnic State University-San Luis Obispo 1995 — 1999
Microbiology, General
Relypsa June 2015 - Present
Pharmacyclics August 2013 - June 2015
Affymax, Inc December 2012 - April 2013
Campbell Alliance March 2012 - August 2012
Campbell Alliance November 2010 - March 2012
Bayer May 2010 - November 2010
Cubist Pharmaceuticals January 2010 - April 2010
The Christ Hospital August 2008 - January 2010
Skills
Market Access
Education
Massachusetts College of Pharmacy and Health Sciences 2003 — 2008
Pharm.D
Keryx Biopharmaceuticals July 2014 - Present
Novartis September 2013 - July 2014
Affymax, Inc. February 2012 - May 2013
Fresenius Medical Care November 2008 - May 2011
Amgen August 2007 - November 2008
Amgen July 2006 - August 2007
Amgen July 2003 - July 2006
Amgen March 1997 - June 2003
Skills
Oncology, Compliance, Start-ups, Change Management, Managed Care, Pharmaceuticals, Pharmaceutical Sales, Healthcare, Hospitals, Consultative Selling, Biotechnology, Team Building, Mentoring, Cross-functional Team..., Strategic Planning, Sales Management, Contract Negotiation, Product Launches, Account Management, Contract Negotiations, Nephrology, Contract Management, Hematology, Business Planning, Coaching, Budgeting, Leadership Development, Cardiology, Pharmaceutical Industry, Pulmonology, Product Launch, Selling, Lifesciences, Management, Leadership, Training, Sales
Education
American Graduate School of International Management
MBA, International Management
University of North Carolina at Chapel Hill
Bachelors, Mathematics
American Academy of Physical Medicine & Rehabilitation (AAPM&R) March 2015 - Present
City of Alexandria, VA 2003 - Present
Affymax, Inc August 2011 - May 2013
American Society of Nephrology 2002 - 2011
National Health Council 1999 - 2002
American Parkinson Disease Association 1992 - 1999
Skills
Public Policy, Public Affairs, Legislative Relations, Policy, Event Management, Political Campaigns, Non-profits, Fundraising, Nonprofits, Government, Coalitions, Policy Analysis, Grassroots Organizing, Politics, Leadership, Strategy, Public Speaking, Community Outreach, Management, Volunteer Management, Program Management, Federal Government, Legislation, Program Development, Grants, Legislative Affairs, Grant Writing, Strategic Communications, Foreign Policy, Event Planning, Governmental Affairs, Healthcare, Media Relations, Strategic Planning, Budgets, Economic Development, Community Development, Analysis, Political Communication, Public Administration, Speech Writing, Political Consulting, Constituent Services, Crisis Communications, Local Government, State Government, Biopharmaceuticals, Message Development, Land Use, Health Policy
Education
Thomas C. Sorensen Institute for Political Leadership, University of Virginia 2000 — 2001
Fellow, Class of 2001
Allegheny College
BS, Economics & BA, History
Lab Support 2014 - 2014
Affymax, Inc. October 2012 - March 2013
Adzilla Inc. May 2008 - October 2008
Franklin Templeton Group June 2001 - September 2007
Skills
Heavy Calendaring, Customer Service, Human Resources, Interviews, Management, Leadership, Onboarding, Start-ups, Recruiting, HRIS, Training, Pharmaceutical Industry, Hiring, Biotechnology
Education
Notre Dame de Namur University
Jazz Pharmaceuticals August 2015 - Present
CDISC 2007 - Present
FibroGen, Inc. October 2014 - August 2015
Onyx Pharmaceuticals April 2013 - September 2014
Affymax, Inc. February 2010 - April 2013
Exelixis July 2008 - January 2010
Independent Consultant July 2007 - July 2008
CV Therapeutics 2002 - 2007
SCDM 2002 - 2004
PPD November 2000 - April 2002
Skills
Clinical Trials, SOP, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Data Management, CDM, CRO, Regulatory Affairs, 21 CFR Part 11, CDISC, SAS, Drug Development, Biotechnology, Sop, CTMS, SDTM, CRF design, Data Management, EDC, GCP, Clinical Development, Clinical Study Design, Regulatory Submissions, ICH-GCP, Computer System..., Therapeutic Areas, Oracle Clinical, FDA, SAS programming, Biostatistics, Infectious Diseases, Lifesciences, Validation, Pharmacovigilance, Medical Writing, Vaccines, Inform, Protocol, SAS Programming, Life Sciences
Education
The University of Edinburgh 1971 — 1973
MPhil, Statistics
Portsmouth University 1968 — 1971
BSc, Mathematics
Astellas Pharma November 2013 - Present
The Medical Affairs Company/Takeda Pharmaceuticals International May 2013 - October 2013
Affymax, Inc. June 2011 - May 2013
AMAG Pharmaceuticals 2008 - August 2011
Roche Labs, Inc 2006 - 2008
Scios, Inc. August 2001 - July 2006
Skills
Cardiology, Pharmaceutical Sales, Managed Care, Biotechnology, Strategic Planning, Pharmaceutical Industry, Strategy, Oncology, Analysis, Rheumatology, Medicare, Training, Medicaid, Nephrology, Sales Operations, Market Access, Endocrinology, Clinical Research, Hospital Sales, Gastroenterology, Pulmonology
Education
The Citadel 1987 — 1991
BA, Political Science
Troy University 2004 — 2007
MBA, General Management
University of South Carolina-Columbia 2007 — 2012
PhD, Health Services Policy and Management, Norman J. Arnold School of Public Health
University of Washington 2013 — 2014
Graduate Certificate, Health Economics and Outcomes Research
Pharmacyclics April 2013 - Present
Alexza Pharmaceuticals October 2011 - December 2011
Affymax, Inc. April 2007 - July 2011
SuperGen, Inc. (Astex Pharmaceuticals) November 2000 - April 2007
AB Mauri Fleischmann's June 1989 - November 2000
Skills
21 CFR Part 11, FDA, CAPA, Analytical Chemistry, Validation, GLP, HPLC, UV/Vis Spectroscopy, Karl Fisher Titration, Data review and analysis, OOS and OOT..., MS office, proprietary..., cGMPs related to QC..., Stability..., Preventive maintenance,..., Sop, UV/Vis, GMP
Education
University of Santo Tomas
Bachelor of Science in Food Technology
Avidity NanoMedicines February 2014 - Present
CovX (Pfizer BTx) June 2009 - May 2013
Durect Corporation November 2005 - December 2008
Chiron Corporation (Novartis Vaccines and Diagnostics) August 2004 - July 2005
MedImmune Vaccines (AstraZeneca) December 2001 - July 2004
Affymax Inc 1993 - 2001
Skills
Analytical Methods..., Analytical Method..., Antibody Drug Conjugates, Peptide Synthesis, Protein Chemistry, Antibodies, Chromatography, HPLC, LC-MS, Drug Delivery, Peptides, Biotechnology, Purification, Biopharmaceuticals, Organic Chemistry, Analytical Chemistry, Drug Development, Drug Discovery, Formulation, Medicinal Chemistry, Characterization, Oncology, Drug Design, R&D, Technology Transfer, Monoclonal Antibodies, Organic Synthesis, Method Development
Education
University of Madras
Ph.D., Organic Chemistry
von der Groeben Consulting, LLC 2011 - Present
Affymax, Inc. 2008 - 2011
Genentech 2001 - 2007
Clinimetrics 2000 - 2001
Clinimetrics Research Associates 2000 - 2001
ALZA Corporation 1996 - 2000
Syntex 1988 - 1995
Skills
Clinical QA, GCP, Clinical Trials, Quality Assurance, Clinical Research, Regulatory Affairs, Oncology, Clinical Development, GLP, FDA, Biotechnology, 21 CFR Part 11, CRO, Drug Development, Infectious Diseases
Education
UCSF 1982 — 1984
MS, Cardiovascular Nursing, Medical
Skidmore College
BS, Nursing
Affymax, Inc. February 2012 - Present
Genzyme October 1998 - February 2012
Cephalon January 1995 - October 1998
Hoffman-LaRoche January 1992 - February 1995
Pharmaco January 1990 - March 1992
Skills
Neurology, Nephrology, Endocrinology, Biotechnology, Oncology, Urology
Education
Sam Houston State University
RotaCare Bay Area, Inc. 2010 - Present
Affymax, Inc. July 2009 - April 2013
El Camino Hospital 2008 - 2008
Dynacare Kasper Medical Laboratories 2003 - 2004
Skills
Pharmacovigilance, Clinical Trials, Clinical Development, Pharmaceutical Industry, Clinical Research
Education
DeAnza College 2006 — 2008
Associate's degree, Nursing, Graduated with GPA of 4.0
University of Alberta
Bachelor Degree, Business
Northern Alberta Institute of Technology / NAIT
Medical Laboratory Assistant Certificate
Bayer HealthCare July 2013 - Present
Affymax, Inc. March 2012 - May 2013
Genzyme March 2002 - March 2012
Merck November 1999 - March 2002
Education
James Madison University 1983 — 1987
Bachelor of Business Administration, Double Major: Management Information Systems & Business Management
Becton, Dickinson and Company 2010 - Present
Becton, Dickinson and Company 2003 - 2010
Affymax Inc. 2002 - 2003
MedImmune 1997 - 2002
MedImmune 1995 - 1997
Skills
FDA, Biotechnology, Medical Devices, Life Sciences, Assay Development, Cell Culture, Validation, GMP, Immunology, Pharmaceutical Industry, R&D, CAPA, Sop, Molecular Biology, V&V
Education
University of Iowa 1992 — 1995
Master of Science (MS)
Huazhong University of Science and Technology 1984 — 1988
Bachelor of Science (BS)
General Capacitor Intl., Inc. May 2014 - Present
ReCarbon, Inc. December 2012 - June 2013
Amarante Technologies, Inc. December 2008 - August 2012
Metrology Equipment Services, LLC March 2003 - October 2008
Affymax, Inc. November 1998 - January 2003
Lam Research Corp. October 1996 - October 1998
Orbitek Engineering, Inc. January 1994 - October 1996
Praxair, Inc. January 1992 - December 1993
Process & Cryogenics Services, Inc. June 1990 - December 1991
Xidex, Inc. February 1988 - June 1990
Skills
Electronics, R&D, Supplier Sourcing, Metal Fabrication, Electrical..., Mechanical Assembly, Wiring, Technical Documentation
Education
Heald College-Rancho Cordova 1987 — 1988
Associate of Arts and Sciences (AAS), Electrical and Electronics Engineering