Janssen Alzheimer Immunotherapy
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Janssen Alzheimer Immunotherapy Employees
Employee
Years
Job
Industry
Briana K. Davis, MSM, CCDM Briana K. Davis, MSM, CCDM's Janssen Alzheimer Immunotherapy Experience April 2011 - December 2012
Job Manager, Clinical Data Management at Clovis Oncology
Industry Pharmaceuticals
Experience
Clovis Oncology June 2015 - Present
Clovis Oncology (Advanced Clinical) November 2014 - June 2015
Exelixis December 2013 - November 2014
Exelixis (Real Staffing) May 2013 - December 2013
Pharmacyclics January 2013 - May 2013
JANSSEN Alzheimer Immunotherapy April 2011 - December 2012
JANSSEN Alzheimer Immunotherapy (Advanced Clinical) June 2010 - April 2011
ICON Clinical Research January 2009 - February 2010
ICON Clinical Research June 2006 - December 2008
Department of Veterans Affairs Cooperative Studies Program Palo Alto April 2004 - June 2006
Skills
Clinical Data Management, EDC, Database Design, Database Lock, Clinical Trials, Strategic Planning, Vendor Management, Project Planning, Project Management, GCP, Leadership, CRO, Data Management, GxP, FDA, ICH-GCP, 21 CFR Part 11, SDTM, CDISC, Sop, Medidata, Oracle Clinical, Inform, BioClinica, SAE Reconciliation, Clinical Development, MedDRA, SOP development, SAS, CTMS, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, Management, MS Project, Timelines, CRF design, Change Control, Validation, Protocol, Lab Reconciliation, Medical Devices, Neurology, Immunology, Oncology, Cardiology, Infectious Diseases, Clinical Research, Drug Development, Biopharmaceuticals
Education
Notre Dame de Namur University
Master of Science (MS), Management
University of California, Santa Cruz
BA, Anthropology
Clovis Oncology June 2015 - Present
Clovis Oncology (Advanced Clinical) November 2014 - June 2015
Exelixis December 2013 - November 2014
Exelixis (Real Staffing) May 2013 - December 2013
Pharmacyclics January 2013 - May 2013
JANSSEN Alzheimer Immunotherapy April 2011 - December 2012
JANSSEN Alzheimer Immunotherapy (Advanced Clinical) June 2010 - April 2011
ICON Clinical Research January 2009 - February 2010
ICON Clinical Research June 2006 - December 2008
Department of Veterans Affairs Cooperative Studies Program Palo Alto April 2004 - June 2006
Skills
Clinical Data Management, EDC, Database Design, Database Lock, Clinical Trials, Strategic Planning, Vendor Management, Project Planning, Project Management, GCP, Leadership, CRO, Data Management, GxP, FDA, ICH-GCP, 21 CFR Part 11, SDTM, CDISC, Sop, Medidata, Oracle Clinical, Inform, BioClinica, SAE Reconciliation, Clinical Development, MedDRA, SOP development, SAS, CTMS, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, Management, MS Project, Timelines, CRF design, Change Control, Validation, Protocol, Lab Reconciliation, Medical Devices, Neurology, Immunology, Oncology, Cardiology, Infectious Diseases, Clinical Research, Drug Development, Biopharmaceuticals
Education
Notre Dame de Namur University
Master of Science (MS), Management
University of California, Santa Cruz
BA, Anthropology
Sally Schroeter Sally Schroeter's Janssen Alzheimer Immunotherapy Experience September 2009 - October 2012
Job Director, Preclinical Neuropathology
Industry Pharmaceuticals
Experience
NeuroPhage January 2013 - Present
Elan Pharmaceuticals September 2004 - December 2012
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Pharmacia 2000 - 2003
Skills
Alzheimer's disease, Neuroanatomy, Neurodegeneration, Parkinson's, Neuroscience, In Vivo, Animal Models, Immunohistochemistry, Histology, Microscopy, Fluorescence Microscopy, Confocal Microscopy, Electron Microscopy, Pharmacology, In Vitro, Cell Biology, Lifesciences, Biotechnology, Disease, Cell, Antibodies, Protein Chemistry, Biomarkers, Life Sciences, Drug Discovery
Education
University of Michigan
Ph.D., Biology/Biological Sciences, General
Nebraska Wesleyan University
Bachelor of Science (BS), Biology/Biological Sciences, General
NeuroPhage January 2013 - Present
Elan Pharmaceuticals September 2004 - December 2012
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Pharmacia 2000 - 2003
Skills
Alzheimer's disease, Neuroanatomy, Neurodegeneration, Parkinson's, Neuroscience, In Vivo, Animal Models, Immunohistochemistry, Histology, Microscopy, Fluorescence Microscopy, Confocal Microscopy, Electron Microscopy, Pharmacology, In Vitro, Cell Biology, Lifesciences, Biotechnology, Disease, Cell, Antibodies, Protein Chemistry, Biomarkers, Life Sciences, Drug Discovery
Education
University of Michigan
Ph.D., Biology/Biological Sciences, General
Nebraska Wesleyan University
Bachelor of Science (BS), Biology/Biological Sciences, General
Darren Snellgrove Darren Snellgrove's Janssen Alzheimer Immunotherapy Experience September 2009 - October 2012
Job CFO Johnson & Johnson Innovation
Industry Pharmaceuticals
Experience
Johnson & Johnson October 2012 - Present
Janssen Alzheimer Immunotherapy September 2009 - October 2012
Cordis August 2007 - October 2009
Scios / Alza 2005 - 2007
Johnson & Johnson 2002 - 2005
Centocor 1997 - 2002
Skills
Procurement, Options, Structures, Mergers, Divestitures, Leadership, Biotechnology, Sarbanes-Oxley Act, Financial Modeling, Process Improvement, Forecasting, SAP, Financial Analysis, Budget, Cross-functional Team..., Budgets, Mergers & Acquisitions, Financial Reporting, Finance, Project Management, Accounting, Analysis, Business Development, Start-ups, Strategic Planning, Valuation, Strategy, Pharmaceutical Industry, Medical Devices, Business Strategy, Management
Education
Villanova University 1998 — 2001
MBA, Finance
University of Southampton 1992 — 1995
BA Honors, Philosophy and Economics
Johnson & Johnson October 2012 - Present
Janssen Alzheimer Immunotherapy September 2009 - October 2012
Cordis August 2007 - October 2009
Scios / Alza 2005 - 2007
Johnson & Johnson 2002 - 2005
Centocor 1997 - 2002
Skills
Procurement, Options, Structures, Mergers, Divestitures, Leadership, Biotechnology, Sarbanes-Oxley Act, Financial Modeling, Process Improvement, Forecasting, SAP, Financial Analysis, Budget, Cross-functional Team..., Budgets, Mergers & Acquisitions, Financial Reporting, Finance, Project Management, Accounting, Analysis, Business Development, Start-ups, Strategic Planning, Valuation, Strategy, Pharmaceutical Industry, Medical Devices, Business Strategy, Management
Education
Villanova University 1998 — 2001
MBA, Finance
University of Southampton 1992 — 1995
BA Honors, Philosophy and Economics
Pamela Keenan, PhD, ABPP Pamela Keenan, PhD, ABPP's Janssen Alzheimer Immunotherapy Experience January 2011 - January 2013
Job Board Certified Clinical Neuropsychologist
Industry Mental Health Care
Experience
CROnos Clinical Consulting March 2013 - January 2015
JANSSEN Alzheimer Immunotherapy January 2011 - January 2013
Johnson and Johnson 2005 - February 2011
Janssen Medical Affairs 2003 - 2005
Wayne State University School of Medicine 1999 - 2003
Harper Hospital, Detroit, Michigan 1991 - 2003
UNC Chapel Hill 1988 - 1989
Skills
Alzheimer's disease, Cognition, Neuropsychological..., Clinical Research, Clinical Trials, Medical Affairs, Neuropsychology, Medicine, Psychology, Science, Medical Writing, GCP
Education
University of North Carolina at Chapel Hill 1988 — 1989
Postdoctoral Research Fellow
San Diego VA Medical Center 1986 — 1987
APA Neuropsychology Internship
University of California, San Diego 1986 — 1987
Clinical Internship, Clinical Neuropsychology
Wayne State University 1983 — 1987
PhD, Clinical Psychology
University of Michigan 1982 — 1983
BA, Psychology
CROnos Clinical Consulting March 2013 - January 2015
JANSSEN Alzheimer Immunotherapy January 2011 - January 2013
Johnson and Johnson 2005 - February 2011
Janssen Medical Affairs 2003 - 2005
Wayne State University School of Medicine 1999 - 2003
Harper Hospital, Detroit, Michigan 1991 - 2003
UNC Chapel Hill 1988 - 1989
Skills
Alzheimer's disease, Cognition, Neuropsychological..., Clinical Research, Clinical Trials, Medical Affairs, Neuropsychology, Medicine, Psychology, Science, Medical Writing, GCP
Education
University of North Carolina at Chapel Hill 1988 — 1989
Postdoctoral Research Fellow
San Diego VA Medical Center 1986 — 1987
APA Neuropsychology Internship
University of California, San Diego 1986 — 1987
Clinical Internship, Clinical Neuropsychology
Wayne State University 1983 — 1987
PhD, Clinical Psychology
University of Michigan 1982 — 1983
BA, Psychology
Dong Wei Dong Wei's Janssen Alzheimer Immunotherapy Experience March 2011 - December 2012
Job
Industry Biotechnology
Experience
Johnson & Johnson January 2013 - Present
Janssen Alzheimer Immunotherapy March 2011 - December 2012
Elan Pharmaceutical July 2007 - April 2011
BioMarin Pharmaceutical Inc March 2006 - June 2007
Deloitte Consulting March 2003 - March 2006
Skills
Biotechnology, Clinical Development, Pharmaceutical Industry, Lifesciences, Program Management, Product Development, Regulatory Affairs, Clinical Trials, Drug Development, CMC, Business Intelligence, Business Analysis, Oncology, Project Management, Biopharmaceuticals
Education
University of Pennsylvania - The Wharton School 2001 — 2003
MBA
Michigan State University 1991 — 1995
Ph.D., Microbiology
Peking University 1987 — 1991
B.S., Genetics
Johnson & Johnson January 2013 - Present
Janssen Alzheimer Immunotherapy March 2011 - December 2012
Elan Pharmaceutical July 2007 - April 2011
BioMarin Pharmaceutical Inc March 2006 - June 2007
Deloitte Consulting March 2003 - March 2006
Skills
Biotechnology, Clinical Development, Pharmaceutical Industry, Lifesciences, Program Management, Product Development, Regulatory Affairs, Clinical Trials, Drug Development, CMC, Business Intelligence, Business Analysis, Oncology, Project Management, Biopharmaceuticals
Education
University of Pennsylvania - The Wharton School 2001 — 2003
MBA
Michigan State University 1991 — 1995
Ph.D., Microbiology
Peking University 1987 — 1991
B.S., Genetics
Katie MacQuien Katie MacQuien's Janssen Alzheimer Immunotherapy Experience May 2011 - December 2012
Job Manager, Clinical Operations Oncology
Industry Pharmaceuticals
Experience
BioMarin Pharmaceutical Inc. September 2014 - Present
Onyx Pharmaceuticals January 2013 - August 2014
JANSSEN Alzheimer Immunotherapy May 2011 - December 2012
Janssen Alzheimer Immunotherapy/Elan Pharmaceuticals January 2008 - May 2011
Amgen April 2005 - January 2008
Skills
Alzheimer's disease, ICH-GCP, Clinical Trials, Clinical Operations, Clinical Study Design, Clinical Research, Vendor Management, FDA Inspection Readiness, Protocol
Education
University of California, Los Angeles 2002 — 2004
BS, Biology
BioMarin Pharmaceutical Inc. September 2014 - Present
Onyx Pharmaceuticals January 2013 - August 2014
JANSSEN Alzheimer Immunotherapy May 2011 - December 2012
Janssen Alzheimer Immunotherapy/Elan Pharmaceuticals January 2008 - May 2011
Amgen April 2005 - January 2008
Skills
Alzheimer's disease, ICH-GCP, Clinical Trials, Clinical Operations, Clinical Study Design, Clinical Research, Vendor Management, FDA Inspection Readiness, Protocol
Education
University of California, Los Angeles 2002 — 2004
BS, Biology
Stephen Caron Stephen Caron's Janssen Alzheimer Immunotherapy Experience March 2012 - April 2013
Job Director of Clinical Operations Finance at Puma Biotechnology
Industry Biotechnology
Experience
Puma Biotechnology March 2014 - Present
Gilead Sciences August 2013 - February 2014
Advance Research Associates April 2013 - August 2013
JANSSEN Alzheimer Immunotherapy March 2012 - April 2013
S. Caron Consulting Services April 2011 - October 2011
BMW of Monterey May 2011 - August 2011
Omnicare Clinical Research / Clinimetrics Research Associates December 2000 - March 2011
Pratt & Whitney Space Propulsion Operations March 1999 - October 2000
Lockheed Martin Missiles and Space January 1997 - March 1999
United Technologies` April 1986 - December 1996
Skills
Cross-functional Team..., Pharmaceutical Industry, Project Planning, Leadership, Analysis, Biotechnology, Manufacturing, Clinical Development, Clinical Trials, GCP, Process Improvement, FDA, Forecasting
Education
University of Illinois at Urbana-Champaign 1984 — 1986
MS, Mechanical Engineering
Harvey Mudd College 1980 — 1984
BS, Engineering, Economics
Puma Biotechnology March 2014 - Present
Gilead Sciences August 2013 - February 2014
Advance Research Associates April 2013 - August 2013
JANSSEN Alzheimer Immunotherapy March 2012 - April 2013
S. Caron Consulting Services April 2011 - October 2011
BMW of Monterey May 2011 - August 2011
Omnicare Clinical Research / Clinimetrics Research Associates December 2000 - March 2011
Pratt & Whitney Space Propulsion Operations March 1999 - October 2000
Lockheed Martin Missiles and Space January 1997 - March 1999
United Technologies` April 1986 - December 1996
Skills
Cross-functional Team..., Pharmaceutical Industry, Project Planning, Leadership, Analysis, Biotechnology, Manufacturing, Clinical Development, Clinical Trials, GCP, Process Improvement, FDA, Forecasting
Education
University of Illinois at Urbana-Champaign 1984 — 1986
MS, Mechanical Engineering
Harvey Mudd College 1980 — 1984
BS, Engineering, Economics
Avis Hains Avis Hains's Janssen Alzheimer Immunotherapy Experience September 2011 - September 2012
Job Director, Global Medical Research
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals February 2015 - Present
Onyx Pharmaceuticals September 2012 - February 2015
JANSSEN Alzheimer Immunotherapy September 2011 - September 2012
Questcor Pharmaceuticals, Inc March 2009 - October 2011
University of Pennsylvania 2002 - 2004
ALS Therapy Development Foundation 2000 - 2001
Skills
Analysis, Biopharmaceuticals, Biotechnology, Clinical Development, Clinical Research, Clinical Trials, FDA, Immunology, Leadership, Medical Affairs, Medical Education, Medicine, Neuroscience, Oncology, Pharmaceutical Industry, Protocol, R, Therapeutic Areas, Sop, Research
Education
Stanford University 2008 — 2009
Postdoc, Neuroscience
Yale University 2004 — 2009
Ph.D., Neuroscience
Harvard University Graduate School of Education 2001 — 2002
Ed.M., Developmental Psychology, Education
Haverford College 1997 — 2001
BA, Biology, Psychology
Onyx Pharmaceuticals February 2015 - Present
Onyx Pharmaceuticals September 2012 - February 2015
JANSSEN Alzheimer Immunotherapy September 2011 - September 2012
Questcor Pharmaceuticals, Inc March 2009 - October 2011
University of Pennsylvania 2002 - 2004
ALS Therapy Development Foundation 2000 - 2001
Skills
Analysis, Biopharmaceuticals, Biotechnology, Clinical Development, Clinical Research, Clinical Trials, FDA, Immunology, Leadership, Medical Affairs, Medical Education, Medicine, Neuroscience, Oncology, Pharmaceutical Industry, Protocol, R, Therapeutic Areas, Sop, Research
Education
Stanford University 2008 — 2009
Postdoc, Neuroscience
Yale University 2004 — 2009
Ph.D., Neuroscience
Harvard University Graduate School of Education 2001 — 2002
Ed.M., Developmental Psychology, Education
Haverford College 1997 — 2001
BA, Biology, Psychology
Stef HEYLEN, MD Stef HEYLEN, MD's Janssen Alzheimer Immunotherapy Experience March 2012 - April 2013
Job Chief Operating Officer at Janssen, Pharmaceutical Companies of Johnson and Johnson
Industry Hospital & Health Care
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2014 - Present
Johnson & Johnson April 2014 - September 2014
Johnson & Johnson May 2013 - April 2014
JANSSEN Alzheimer Immunotherapy March 2012 - April 2013
JANSSEN Alzheimer Immunotherapy September 2009 - March 2012
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2007 - September 2009
Tibotec August 2003 - August 2007
Crucell February 2002 - July 2003
Janssen-Cilag April 2000 - February 2002
Janssen, Pharmaceutical Companies of Johnson and Johnson June 1996 - March 2000
Skills
Biotechnology, Pharmaceutical Industry, Clinical Development, R&D, Vaccines, Infectious Diseases, Immunology, Pharmacovigilance, Clinical Research, Neurology, Regulatory Affairs, Project Portfolio..., medical aff
Education
Prins Leopold Instituut voor Tropische Geneeskunde 1983 — 1983
Doctor of Medicine (MD), Tropical Diseases
Katholieke Universiteit Leuven 1976 — 1983
Doctor of Medicine (MD), Tropical Diseases
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2014 - Present
Johnson & Johnson April 2014 - September 2014
Johnson & Johnson May 2013 - April 2014
JANSSEN Alzheimer Immunotherapy March 2012 - April 2013
JANSSEN Alzheimer Immunotherapy September 2009 - March 2012
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2007 - September 2009
Tibotec August 2003 - August 2007
Crucell February 2002 - July 2003
Janssen-Cilag April 2000 - February 2002
Janssen, Pharmaceutical Companies of Johnson and Johnson June 1996 - March 2000
Skills
Biotechnology, Pharmaceutical Industry, Clinical Development, R&D, Vaccines, Infectious Diseases, Immunology, Pharmacovigilance, Clinical Research, Neurology, Regulatory Affairs, Project Portfolio..., medical aff
Education
Prins Leopold Instituut voor Tropische Geneeskunde 1983 — 1983
Doctor of Medicine (MD), Tropical Diseases
Katholieke Universiteit Leuven 1976 — 1983
Doctor of Medicine (MD), Tropical Diseases
Steve Einstein Steve Einstein's Janssen Alzheimer Immunotherapy Experience 2010 - 2013
Job Consultant at Lyscaut
Industry Pharmaceuticals
Experience
Lyscaut March 2010 - Present
Steve Einstein Consulting Services May 2007 - Present
JANSSEN Alzheimer Immunotherapy 2010 - 2013
JANSSEN Alzheimer Immunotherapy 2010 - 2012
Bio-Imaging Technologies, Inc. November 1992 - April 2007
General Electric March 1989 - November 1992
Philips Medical Systems February 1981 - January 1989
EMI Medical January 1980 - January 1981
Education
Hershey Medical Center, Pennsylvania State University 1977 — 1979
MSE, BioMedical Engineering
Stony Brook University 1973 — 1977
BSEE, Electrical Engineering, minor BioMedical
Lyscaut March 2010 - Present
Steve Einstein Consulting Services May 2007 - Present
JANSSEN Alzheimer Immunotherapy 2010 - 2013
JANSSEN Alzheimer Immunotherapy 2010 - 2012
Bio-Imaging Technologies, Inc. November 1992 - April 2007
General Electric March 1989 - November 1992
Philips Medical Systems February 1981 - January 1989
EMI Medical January 1980 - January 1981
Education
Hershey Medical Center, Pennsylvania State University 1977 — 1979
MSE, BioMedical Engineering
Stony Brook University 1973 — 1977
BSEE, Electrical Engineering, minor BioMedical
Joe Warlow Joe Warlow's Janssen Alzheimer Immunotherapy Experience February 2010 - Present
Job Director, Clinical Data Management at Janssen Alzheimer Immunotherapy
Industry Pharmaceuticals
Experience
Janssen Alzheimer Immunotherapy February 2010 - Present
Johnson & Johnson Pharmaceutical Research & Development 2008 - March 2010
ALZA 2001 - 2007
SAS 2000 - 2001
PPD Informatics 2000 - 2001
XOMA (US) LLC 1999 - 2000
Otsuka 1994 - 1999
syntex 1991 - 1994
Skills
SAS programming, Clinical Data Management, Clinical Trials, Project Management, EDC, 21 CFR Part 11, CDISC, Sop, Pharmaceutical Industry, Biotechnology, Computer System..., Oncology, Clinical Research, SAS, CRO, Validation, FDA, Clinical Development, Regulatory Submissions, Process Simulation, Six Sigma, Data Management, Drug Development, GCP
Education
The Ohio State University 1976 — 1978
Master of Science (MS), Geology/Earth Science, General
Millersville University of Pennsylvania 1970 — 1975
BA, Earth Science
Janssen Alzheimer Immunotherapy February 2010 - Present
Johnson & Johnson Pharmaceutical Research & Development 2008 - March 2010
ALZA 2001 - 2007
SAS 2000 - 2001
PPD Informatics 2000 - 2001
XOMA (US) LLC 1999 - 2000
Otsuka 1994 - 1999
syntex 1991 - 1994
Skills
SAS programming, Clinical Data Management, Clinical Trials, Project Management, EDC, 21 CFR Part 11, CDISC, Sop, Pharmaceutical Industry, Biotechnology, Computer System..., Oncology, Clinical Research, SAS, CRO, Validation, FDA, Clinical Development, Regulatory Submissions, Process Simulation, Six Sigma, Data Management, Drug Development, GCP
Education
The Ohio State University 1976 — 1978
Master of Science (MS), Geology/Earth Science, General
Millersville University of Pennsylvania 1970 — 1975
BA, Earth Science
Jean Maupas Jean Maupas's Janssen Alzheimer Immunotherapy Experience 2012 - 2012
Job Senior Consultant
Industry Biotechnology
Experience
Self-employed January 2005 - Present
Boston Scientific November 2014 - June 2015
Clinovo July 2012 - November 2014
JANSSEN Alzheimer Immunotherapy 2012 - 2012
Biovail April 2007 - July 2010
GEREQ 2001 - 2006
ClinInfo 1998 - 2001
APRET / EZUS 1989 - 1998
Skills
Management, Software Engineering, Computer System..., Project Management, Operations Management, Quality Assurance, Biometrics, Clinical Data Management, Clinical Research, Validation, FDA, CRO, EDC, Clinical Trials, Pharmaceuticals, Biotechnology, SOP, Life Sciences, Oncology, GCP, Data Management, Data Analysis, Cardiovascular Medicine, Sop, Lifesciences, CTMS, CDISC, Pharmaceutical Industry, Medicine, SAS, GxP, CAPA, Clinical Development, SAS programming, Regulatory Submissions, 21 CFR Part 11, Protocol
Education
Université Paris - Val-de-Marne (Paris XII) 1983 — 1985
Master, Biomathematics, Informatics and statistics
Miage 1982 — 1985
Computer Science
Université Claude Bernard (Lyon I) 1977 — 1985
MD, Residency in Public Health & Clinical Research
Self-employed January 2005 - Present
Boston Scientific November 2014 - June 2015
Clinovo July 2012 - November 2014
JANSSEN Alzheimer Immunotherapy 2012 - 2012
Biovail April 2007 - July 2010
GEREQ 2001 - 2006
ClinInfo 1998 - 2001
APRET / EZUS 1989 - 1998
Skills
Management, Software Engineering, Computer System..., Project Management, Operations Management, Quality Assurance, Biometrics, Clinical Data Management, Clinical Research, Validation, FDA, CRO, EDC, Clinical Trials, Pharmaceuticals, Biotechnology, SOP, Life Sciences, Oncology, GCP, Data Management, Data Analysis, Cardiovascular Medicine, Sop, Lifesciences, CTMS, CDISC, Pharmaceutical Industry, Medicine, SAS, GxP, CAPA, Clinical Development, SAS programming, Regulatory Submissions, 21 CFR Part 11, Protocol
Education
Université Paris - Val-de-Marne (Paris XII) 1983 — 1985
Master, Biomathematics, Informatics and statistics
Miage 1982 — 1985
Computer Science
Université Claude Bernard (Lyon I) 1977 — 1985
MD, Residency in Public Health & Clinical Research
Chris Leibman's Janssen Alzheimer Immunotherapy Experience 2009 - 2012
Job Vice President, HEOR Global Market Access at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec January 2014 - Present
Janssen Pharmaceuticals 2012 - 2014
Janssen Alzheimer Immunotherapy 2009 - 2012
Elan Pharmaceuticals, Inc 2005 - 2009
AstraZeneca 2002 - 2005
GlaxoSmithKline 2000 - 2002
Searle 1997 - 2000
Education
The Ohio State University
MS, Pharmacoeconomics
University of Illinois at Chicago
PharmD
University of Illinois at Urbana-Champaign
BS, Biology, Chemistry
Biogen Idec January 2014 - Present
Janssen Pharmaceuticals 2012 - 2014
Janssen Alzheimer Immunotherapy 2009 - 2012
Elan Pharmaceuticals, Inc 2005 - 2009
AstraZeneca 2002 - 2005
GlaxoSmithKline 2000 - 2002
Searle 1997 - 2000
Education
The Ohio State University
MS, Pharmacoeconomics
University of Illinois at Chicago
PharmD
University of Illinois at Urbana-Champaign
BS, Biology, Chemistry
Daniel Millar Daniel Millar's Janssen Alzheimer Immunotherapy Experience August 2011 - August 2012
Job Senior Director, Business Transformation at Janssen
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2014 - Present
Johnson & Johnson February 2010 - January 2014
Crucell May 2011 - January 2013
JANSSEN Alzheimer Immunotherapy August 2011 - August 2012
JANSSEN-CILAG May 2008 - January 2010
J&J Pharmaceutical Research & Development December 2005 - April 2008
Tunnel Consulting 2002 - 2004
Bristol Myers Squibb 1999 - 2001
Skills
Change Management, Strategy, Management Consulting, Cross-functional Team..., Pharmaceutical Industry, Quality Assurance, Six Sigma, Clinical Operations, Management, Business Transformation, Business Process..., R&D, Project Management, Integration, Process Improvement, Mergers & Acquisitions, Clinical Trials, Program Management, Acquisition Integration, Continuous Improvement, Leadership, Strategic Alliances, R&D Operations, Commercialization
Education
The University of Chicago - Booth School of Business 2003 — 2005
MBA, Finance and Entrepreneurship
University of Pennsylvania 1994 — 1997
BA, Mathematics, Physics, Latin
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2014 - Present
Johnson & Johnson February 2010 - January 2014
Crucell May 2011 - January 2013
JANSSEN Alzheimer Immunotherapy August 2011 - August 2012
JANSSEN-CILAG May 2008 - January 2010
J&J Pharmaceutical Research & Development December 2005 - April 2008
Tunnel Consulting 2002 - 2004
Bristol Myers Squibb 1999 - 2001
Skills
Change Management, Strategy, Management Consulting, Cross-functional Team..., Pharmaceutical Industry, Quality Assurance, Six Sigma, Clinical Operations, Management, Business Transformation, Business Process..., R&D, Project Management, Integration, Process Improvement, Mergers & Acquisitions, Clinical Trials, Program Management, Acquisition Integration, Continuous Improvement, Leadership, Strategic Alliances, R&D Operations, Commercialization
Education
The University of Chicago - Booth School of Business 2003 — 2005
MBA, Finance and Entrepreneurship
University of Pennsylvania 1994 — 1997
BA, Mathematics, Physics, Latin
Suzanne Goggin Suzanne Goggin's Janssen Alzheimer Immunotherapy Experience July 2009 - March 2011
Job Senior Executive Administrative Assistant at Johnson & Johnson Consumer
Industry Biotechnology
Experience
Johnson & Johnson Consumer March 2011 - Present
Janssen Alzheimer Immunotherapy July 2009 - March 2011
J&J Corporate April 2007 - July 2009
Skills
Administrative..., Confidentiality, Calendars, Calendaring, Outlook, C-level support, Regulatory Affairs, PowerPoint, Microsoft Office, Process Improvement, Office Administration, Office Management, Organization &..., Meeting Planning, Administrative..., Time Management, Data Entry, Spreadsheets
Education
Middlesex County College 1980 — 1983
Associate's Degree, Secretarial Science
Johnson & Johnson Consumer March 2011 - Present
Janssen Alzheimer Immunotherapy July 2009 - March 2011
J&J Corporate April 2007 - July 2009
Skills
Administrative..., Confidentiality, Calendars, Calendaring, Outlook, C-level support, Regulatory Affairs, PowerPoint, Microsoft Office, Process Improvement, Office Administration, Office Management, Organization &..., Meeting Planning, Administrative..., Time Management, Data Entry, Spreadsheets
Education
Middlesex County College 1980 — 1983
Associate's Degree, Secretarial Science
Sally Wu Sally Wu's Janssen Alzheimer Immunotherapy Experience February 2012 - June 2013
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
Gilead Sciences July 2013 - Present
JANSSEN Alzheimer Immunotherapy February 2012 - June 2013
Orexigen Therapeutics Inc April 2009 - February 2012
Optimer Pharmaceuticals February 2011 - August 2011
Amylin Pharmaceuticals, Inc., May 2006 - April 2009
I3 staprobe 2005 - 2006
Isis Pharmaceuticals 2004 - 2005
JPMorgan Chase January 1998 - March 2004
Anthem Blue Cross and Blue Shield June 1996 - December 1997
Skills
FDA, Pharmaceutical Industry, Oncology, SAS, Clinical Research, Clinical Trials, Statistical Programming, CRO, Statistics, Databases, Validation, Clinical Development, CDISC, SQL, Biotechnology, Financial Analysis, Macro, SDTM, Clinical Data Management, 21 CFR Part 11, GCP
Education
Miami University
MBA
Gilead Sciences July 2013 - Present
JANSSEN Alzheimer Immunotherapy February 2012 - June 2013
Orexigen Therapeutics Inc April 2009 - February 2012
Optimer Pharmaceuticals February 2011 - August 2011
Amylin Pharmaceuticals, Inc., May 2006 - April 2009
I3 staprobe 2005 - 2006
Isis Pharmaceuticals 2004 - 2005
JPMorgan Chase January 1998 - March 2004
Anthem Blue Cross and Blue Shield June 1996 - December 1997
Skills
FDA, Pharmaceutical Industry, Oncology, SAS, Clinical Research, Clinical Trials, Statistical Programming, CRO, Statistics, Databases, Validation, Clinical Development, CDISC, SQL, Biotechnology, Financial Analysis, Macro, SDTM, Clinical Data Management, 21 CFR Part 11, GCP
Education
Miami University
MBA
Olena Galligan Olena Galligan's Janssen Alzheimer Immunotherapy Experience September 2011 - September 2013
Job Statistical SAS Programmer at Jazz Pharmaceuticals
Industry Pharmaceuticals
Experience
Jazz Pharmaceuticals April 2015 - Present
Theorem Clinical Research October 2013 - April 2015
JANSSEN Alzheimer Immunotherapy September 2011 - September 2013
Teikoku Pharma USA February 2011 - August 2011
ClinOps, formerly Pacific Data Designs September 2009 - January 2011
The Nielsen Company May 2009 - September 2009
Skills
SAS, SQL, Clinical Trials, GCP, Statistics, CDISC, Data Analysis, SAS/SQL, Biostatistics, Survival Analysis, Logistic Regression, Statistical Modeling, SAS programming, Statistical Programming, Analysis, Data Mining, Pharmaceutical Industry, SAS Macro, Software Documentation, CRO, ICH-GCP, SAS Certified Base..., SDTM, ANOVA, Validation, Oncology, Clinical Data Management, Therapeutic Areas, EDC, Drug Development, Data Management, Clinical Study Design, CRF design, SAS Programming
Education
California State University-East Bay 2005 — 2008
Master of Science, Statistics
Jazz Pharmaceuticals April 2015 - Present
Theorem Clinical Research October 2013 - April 2015
JANSSEN Alzheimer Immunotherapy September 2011 - September 2013
Teikoku Pharma USA February 2011 - August 2011
ClinOps, formerly Pacific Data Designs September 2009 - January 2011
The Nielsen Company May 2009 - September 2009
Skills
SAS, SQL, Clinical Trials, GCP, Statistics, CDISC, Data Analysis, SAS/SQL, Biostatistics, Survival Analysis, Logistic Regression, Statistical Modeling, SAS programming, Statistical Programming, Analysis, Data Mining, Pharmaceutical Industry, SAS Macro, Software Documentation, CRO, ICH-GCP, SAS Certified Base..., SDTM, ANOVA, Validation, Oncology, Clinical Data Management, Therapeutic Areas, EDC, Drug Development, Data Management, Clinical Study Design, CRF design, SAS Programming
Education
California State University-East Bay 2005 — 2008
Master of Science, Statistics
Michel Nijs, MBA | MSc Michel Nijs, MBA | MSc's Janssen Alzheimer Immunotherapy Experience 2011 - 2013
Job Disease Area Global Commercial Strategic Analytics Leader Neuroscience
Industry Pharmaceuticals
Experience
The Janssen Pharmaceutical Companies of Johnson & Johnson January 2015 - Present
The Janssen Pharmaceutical Companies of Johnson & Johnson July 2013 - January 2015
Johnson & Johnson 2013 - 2013
Janssen Alzheimer Immunotherapy 2011 - 2013
The Janssen Pharmaceutical Companies of Johnson & Johnson 2009 - 2011
Tibotec Inc, a Johnson & Johnson Company 2006 - 2008
Johnson & Johnson 2001 - 2006
Origin Technology in Business 1994 - 2000
Skills
Biotechnology, Business Solutions..., Capacity Planning, Clinical Development, Clinical Trials, Drug Development, Monte Carlo Simulation, People Development, Pharmaceutical Industry, Planning Systems, Portfolio Performance..., Process Optimization, Leadership & Team..., Project Management, FDA, 21 CFR Part 11, Pharmaceutical R&D..., Program Management, Portfolio Management, Program Launch, Benchmarking, Goal Setting, Risk Management, Statistical Data..., Performance Measurement, Global Alliance..., Conducting, Forecasting, Analytical thinking, Problem Solving, Software knowledge, Communication, Business, Behavioral, Interaction, Analytical Skills, Cross-functional Team..., Change Management, Requirements Analysis, MS Project, Data Analysis, Leadership, Enterprise Architecture
Education
University of Pennsylvania - The Wharton School
MBA
Thomas More Kempen
Masters, Industrial Sciences Electromechanics Computer Sciences, Cum Laude
The Janssen Pharmaceutical Companies of Johnson & Johnson January 2015 - Present
The Janssen Pharmaceutical Companies of Johnson & Johnson July 2013 - January 2015
Johnson & Johnson 2013 - 2013
Janssen Alzheimer Immunotherapy 2011 - 2013
The Janssen Pharmaceutical Companies of Johnson & Johnson 2009 - 2011
Tibotec Inc, a Johnson & Johnson Company 2006 - 2008
Johnson & Johnson 2001 - 2006
Origin Technology in Business 1994 - 2000
Skills
Biotechnology, Business Solutions..., Capacity Planning, Clinical Development, Clinical Trials, Drug Development, Monte Carlo Simulation, People Development, Pharmaceutical Industry, Planning Systems, Portfolio Performance..., Process Optimization, Leadership & Team..., Project Management, FDA, 21 CFR Part 11, Pharmaceutical R&D..., Program Management, Portfolio Management, Program Launch, Benchmarking, Goal Setting, Risk Management, Statistical Data..., Performance Measurement, Global Alliance..., Conducting, Forecasting, Analytical thinking, Problem Solving, Software knowledge, Communication, Business, Behavioral, Interaction, Analytical Skills, Cross-functional Team..., Change Management, Requirements Analysis, MS Project, Data Analysis, Leadership, Enterprise Architecture
Education
University of Pennsylvania - The Wharton School
MBA
Thomas More Kempen
Masters, Industrial Sciences Electromechanics Computer Sciences, Cum Laude
Robin Barbour Robin Barbour's Janssen Alzheimer Immunotherapy Experience September 2009 - October 2012
Job Head of Antibody and Assay Development at Prothena Corporation
Industry Biotechnology
Experience
Prothena Corporation December 2012 - Present
Neotope Biosciences a division of Elan Pharmaceuticals January 2010 - December 2012
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Elan Pharmaceuticals September 1987 - December 2009
Becton Dickinson Immunocytometry 1985 - 1987
Syva 1981 - 1985
Skills
Biacore, Forte-Bio, Hybridoma technology, Assay Development, Drug Discovery, Biotechnology, ELISA, Biochemistry, Protein Chemistry, Lifesciences, Molecular Biology, Immunology, Cell Biology, Cell Culture, Protein Purification, Purification, Flow Cytometry, Laboratory Automation, Western Blotting, SDS-PAGE, GLP, HPLC, Clinical Development, Chromatography, Antibodies, Monoclonal Antibodies, Cell, Hybridoma, Immunoassays, Validation, Laboratory, Biomarker Discovery, Biopharmaceuticals
Education
University of California, Davis 1978 — 1981
BS, Biochemistry
Prothena Corporation December 2012 - Present
Neotope Biosciences a division of Elan Pharmaceuticals January 2010 - December 2012
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Elan Pharmaceuticals September 1987 - December 2009
Becton Dickinson Immunocytometry 1985 - 1987
Syva 1981 - 1985
Skills
Biacore, Forte-Bio, Hybridoma technology, Assay Development, Drug Discovery, Biotechnology, ELISA, Biochemistry, Protein Chemistry, Lifesciences, Molecular Biology, Immunology, Cell Biology, Cell Culture, Protein Purification, Purification, Flow Cytometry, Laboratory Automation, Western Blotting, SDS-PAGE, GLP, HPLC, Clinical Development, Chromatography, Antibodies, Monoclonal Antibodies, Cell, Hybridoma, Immunoassays, Validation, Laboratory, Biomarker Discovery, Biopharmaceuticals
Education
University of California, Davis 1978 — 1981
BS, Biochemistry
Lois C. Johansson Lois C. Johansson's Janssen Alzheimer Immunotherapy Experience 2012 - 2012
Job Procurement & Supply
Industry Internet
Experience
Apple April 2015 - Present
Independent Consultant/Contractor 2014 - April 2015
Jones Lang LaSalle 2012 - 2013
JANSSEN Alzheimer Immunotherapy 2012 - 2012
Kaiser Permanente 2010 - 2012
Logitech 2009 - 2010
Expense Reduction Analysts 2007 - 2009
Johnson & Johnson 2001 - 2007
ALZA Corporation 2001 - 2007
Skills
Procurement, Change Management, Strategic Planning, Program Management, Supplier Development, Procure-to-Pay, Cross-functional Team..., Supplier Diversity, Strategic Sourcing, Project Management
Education
Saint Mary's College of California 2003 — 2005
M.B.A., Management
Biola University
B.S., Business Administration
Apple April 2015 - Present
Independent Consultant/Contractor 2014 - April 2015
Jones Lang LaSalle 2012 - 2013
JANSSEN Alzheimer Immunotherapy 2012 - 2012
Kaiser Permanente 2010 - 2012
Logitech 2009 - 2010
Expense Reduction Analysts 2007 - 2009
Johnson & Johnson 2001 - 2007
ALZA Corporation 2001 - 2007
Skills
Procurement, Change Management, Strategic Planning, Program Management, Supplier Development, Procure-to-Pay, Cross-functional Team..., Supplier Diversity, Strategic Sourcing, Project Management
Education
Saint Mary's College of California 2003 — 2005
M.B.A., Management
Biola University
B.S., Business Administration
Hopkins Poon Hopkins Poon's Janssen Alzheimer Immunotherapy Experience July 2012 - June 2013
Job Clinical Operations at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences July 2015 - Present
Genentech March 2014 - July 2015
Impax Laboratories November 2013 - March 2014
JANSSEN Alzheimer Immunotherapy July 2012 - June 2013
UC Berkeley October 2010 - May 2012
Skills
Biotechnology, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, Pharmaceutical Industry, Clinical Research, Life Sciences, Clinical Trials, SOP, FDA, Data Analysis
Education
University of California, Berkeley
Clinical Research Conduct and Management, Public Health
University of California, Berkeley 2009 — 2012
Bachelor of Arts (B.A.), Public Health
Gilead Sciences July 2015 - Present
Genentech March 2014 - July 2015
Impax Laboratories November 2013 - March 2014
JANSSEN Alzheimer Immunotherapy July 2012 - June 2013
UC Berkeley October 2010 - May 2012
Skills
Biotechnology, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, Pharmaceutical Industry, Clinical Research, Life Sciences, Clinical Trials, SOP, FDA, Data Analysis
Education
University of California, Berkeley
Clinical Research Conduct and Management, Public Health
University of California, Berkeley 2009 — 2012
Bachelor of Arts (B.A.), Public Health
Jean Bunac Jean Bunac's Janssen Alzheimer Immunotherapy Experience August 2011 - October 2012
Job Drug Safety Associate II at Jazz Pharmaceuticals
Industry Pharmaceuticals
Experience
Jazz Pharmaceuticals November 2012 - Present
Thomas John Events 2006 - Present
JANSSEN Alzheimer Immunotherapy August 2011 - October 2012
Advanced Clinical May 2010 - October 2012
BioMarin May 2010 - June 2011
BioSoteria, Inc. September 2007 - April 2010
InterMune June 2005 - September 2007
Amgen, (previously Tularik Inc) March 2004 - November 2004
Gilead Sciences August 1998 - March 2004
First DataBank November 1992 - August 1998
Skills
Pharmacovigilance, Clinical Trials, Sop, GCP, Oncology, FDA, IND, Clinical Development, CRO, Regulatory Affairs, Clinical Research, Validation, Pharmaceutical Industry, Drug Safety, Regulatory Submissions
Education
San Francisco State University
Bachelor of Arts, Liberal Studies
California Culinary Academy 2005 — 2006
Culinary Arts
City College of San Francisco
AA, Business Administration
Jefferson High School
Jazz Pharmaceuticals November 2012 - Present
Thomas John Events 2006 - Present
JANSSEN Alzheimer Immunotherapy August 2011 - October 2012
Advanced Clinical May 2010 - October 2012
BioMarin May 2010 - June 2011
BioSoteria, Inc. September 2007 - April 2010
InterMune June 2005 - September 2007
Amgen, (previously Tularik Inc) March 2004 - November 2004
Gilead Sciences August 1998 - March 2004
First DataBank November 1992 - August 1998
Skills
Pharmacovigilance, Clinical Trials, Sop, GCP, Oncology, FDA, IND, Clinical Development, CRO, Regulatory Affairs, Clinical Research, Validation, Pharmaceutical Industry, Drug Safety, Regulatory Submissions
Education
San Francisco State University
Bachelor of Arts, Liberal Studies
California Culinary Academy 2005 — 2006
Culinary Arts
City College of San Francisco
AA, Business Administration
Jefferson High School
Vinh La's Janssen Alzheimer Immunotherapy Experience September 2010 - October 2012
Job Clinical Research Associate at Portola Pharmaceuticals
Industry Biotechnology
Experience
Portola Pharmaceuticals October 2012 - Present
JANSSEN Alzheimer Immunotherapy September 2010 - October 2012
JANSSEN Alzheimer Immunotherapy 2010 - 2012
NeoTract July 2010 - August 2010
Emphasys Medical November 2006 - July 2007
ICON plc September 2005 - March 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Electronic Data..., GCP, ICH guidelines, FDA GMP, Datafax, Clinical Trials, Clinical Operations, Trial Master File, CTMS, Oracle Clinical, Document Management, ICH-GCP, eTMF, IVRS, Medical Affairs
Education
San Francisco State University 2010 — 2012
Clinical Trails Design and Management Certificate
San Francisco State University
Bachelor of Science (BS), Physiology, General
Portola Pharmaceuticals October 2012 - Present
JANSSEN Alzheimer Immunotherapy September 2010 - October 2012
JANSSEN Alzheimer Immunotherapy 2010 - 2012
NeoTract July 2010 - August 2010
Emphasys Medical November 2006 - July 2007
ICON plc September 2005 - March 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Electronic Data..., GCP, ICH guidelines, FDA GMP, Datafax, Clinical Trials, Clinical Operations, Trial Master File, CTMS, Oracle Clinical, Document Management, ICH-GCP, eTMF, IVRS, Medical Affairs
Education
San Francisco State University 2010 — 2012
Clinical Trails Design and Management Certificate
San Francisco State University
Bachelor of Science (BS), Physiology, General
Nancy Berger Nancy Berger's Janssen Alzheimer Immunotherapy Experience September 2011 - September 2012
Job Quality Specialist at Genentech
Industry Biotechnology
Experience
Genentech September 2013 - Present
Exelixis March 2013 - August 2013
Stanford University, Research Compliance Office November 2012 - March 2013
JANSSEN Alzheimer Immunotherapy September 2011 - September 2012
Roche Genentech September 2009 - April 2011
Roche Pharmaceuticals August 2007 - September 2009
Roche August 2001 - July 2007
US Affiliate Study Management February 2000 - August 2001
Clinical OperationsRoche Global Development June 1998 - February 2000
Cygnus Inc. April 1997 - May 1998
Skills
Clinical Trials, Clinical Development, GCP, Publications, CTMS, CRO, Oncology, Biotechnology, FDA, EDC, IND, Pharmacovigilance, Regulatory Submissions, Clinical Operations, ICH guidelines, IRB, SOP development, GxP, 21 CFR Part 11, Clinical Monitoring, Infectious Diseases, Regulatory Affairs, Medical Writing, Protocol, Clinical Data Management, Medical Affairs, Drug Safety, Biopharmaceuticals, Pharmaceutics, Drug Discovery
Education
University of Colorado Denver 1986 — 1988
B.S.N, Nursing
Genentech September 2013 - Present
Exelixis March 2013 - August 2013
Stanford University, Research Compliance Office November 2012 - March 2013
JANSSEN Alzheimer Immunotherapy September 2011 - September 2012
Roche Genentech September 2009 - April 2011
Roche Pharmaceuticals August 2007 - September 2009
Roche August 2001 - July 2007
US Affiliate Study Management February 2000 - August 2001
Clinical OperationsRoche Global Development June 1998 - February 2000
Cygnus Inc. April 1997 - May 1998
Skills
Clinical Trials, Clinical Development, GCP, Publications, CTMS, CRO, Oncology, Biotechnology, FDA, EDC, IND, Pharmacovigilance, Regulatory Submissions, Clinical Operations, ICH guidelines, IRB, SOP development, GxP, 21 CFR Part 11, Clinical Monitoring, Infectious Diseases, Regulatory Affairs, Medical Writing, Protocol, Clinical Data Management, Medical Affairs, Drug Safety, Biopharmaceuticals, Pharmaceutics, Drug Discovery
Education
University of Colorado Denver 1986 — 1988
B.S.N, Nursing
Debbie Yim's Janssen Alzheimer Immunotherapy Experience December 2010 - April 2011
Job Manager at Onyx Pharmaceuticals
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals March 2013 - Present
Onyx Pharmaceuticals April 2011 - March 2013
JANSSEN Alzheimer Immunotherapy December 2010 - April 2011
Elan Pharmaceuticals December 2009 - November 2010
Aradigm Corporation August 2009 - December 2009
Aradigm Corporation February 2003 - August 2009
Aradigm Corporation January 1999 - February 2003
Aradigm Corporation April 1997 - January 1999
Education
University of California, Davis
Bachelor of Science in Biochemistry
Onyx Pharmaceuticals March 2013 - Present
Onyx Pharmaceuticals April 2011 - March 2013
JANSSEN Alzheimer Immunotherapy December 2010 - April 2011
Elan Pharmaceuticals December 2009 - November 2010
Aradigm Corporation August 2009 - December 2009
Aradigm Corporation February 2003 - August 2009
Aradigm Corporation January 1999 - February 2003
Aradigm Corporation April 1997 - January 1999
Education
University of California, Davis
Bachelor of Science in Biochemistry
Hao Hu Hao Hu's Janssen Alzheimer Immunotherapy Experience April 2011 - May 2013
Job Biostatistical Programming Manager at Amgen
Industry Pharmaceuticals
Experience
Amgen August 2013 - Present
Assent Consulting April 2013 - August 2013
JANSSEN Alzheimer Immunotherapy April 2011 - May 2013
Amylin Pharmaceuticals August 2003 - April 2011
Pfizer Pharmaceuticals April 2002 - August 2003
Skills
CRO, Clinical Trials, Clinical Development, CDISC, Statistical Programming, Biostatistics, Pharmaceutical Industry, Drug Discovery, Computer System..., Drug Development, Clinical Study Design
Education
Mississippi State University 1999 — 2001
Master, Statistics
Amgen August 2013 - Present
Assent Consulting April 2013 - August 2013
JANSSEN Alzheimer Immunotherapy April 2011 - May 2013
Amylin Pharmaceuticals August 2003 - April 2011
Pfizer Pharmaceuticals April 2002 - August 2003
Skills
CRO, Clinical Trials, Clinical Development, CDISC, Statistical Programming, Biostatistics, Pharmaceutical Industry, Drug Discovery, Computer System..., Drug Development, Clinical Study Design
Education
Mississippi State University 1999 — 2001
Master, Statistics
lisa bacolini lisa bacolini's Janssen Alzheimer Immunotherapy Experience March 2012 - November 2012
Job Clinical Program Manager at FibroGen
Industry Biotechnology
Vanni Carapetian Vanni Carapetian's Janssen Alzheimer Immunotherapy Experience June 2011 - July 2013
Job
Industry Biotechnology
Experience
Genentech October 2013 - Present
JANSSEN Alzheimer Immunotherapy June 2011 - July 2013
Amgen June 2008 - June 2011
Amgen November 2006 - June 2008
Amgen October 2005 - November 2006
Education
University of California, Los Angeles - Fielding School of Public Health 2009 — 2011
MPH
Columbia University in the City of New York 2001 — 2005
BS
Genentech October 2013 - Present
JANSSEN Alzheimer Immunotherapy June 2011 - July 2013
Amgen June 2008 - June 2011
Amgen November 2006 - June 2008
Amgen October 2005 - November 2006
Education
University of California, Los Angeles - Fielding School of Public Health 2009 — 2011
MPH
Columbia University in the City of New York 2001 — 2005
BS
Shelia Stephens's Janssen Alzheimer Immunotherapy Experience January 2010 - April 2013
Job
Industry Biotechnology
Experience
Translational Drug Development (TD2) May 2015 - Present
Advance Research Associates March 2015 - April 2015
Cerexa December 2013 - November 2014
Janssen Alzheimer Immunotherapy January 2010 - April 2013
Elan Pharmaceuticals March 2008 - December 2009
ADVANCED BIO-LOGICS SOLUTIONS CORP November 2007 - February 2008
Amgen 2002 - November 2007
Immunex 1991 - 2002
BAXTER HEALTHCARE NOVACOR DIVISION 1989 - 1991
World Saving and Loan 1984 - 1990
Skills
21 CFR Part 11, Clinical Development, GCP, CTMS, CDISC, Oncology, Clinical Trials, Sop, Validation, Biotechnology, FDA, Oracle Clinical, Clinical Data Management, Pharmaceutical Industry, Data Management, Lifesciences, EDC, Regulatory Affairs, CRO, Clinical Research, Medidata, Computer System..., ICH-GCP, Medical Devices, GxP, Protocol
Education
Society for Clinical Data Managment 2013 — 2013
Certified Clinical Data Manager
University of Phoenix 2001 — 2003
Bachelor's degree, Information Technology
Heald Business College 1983 — 1984
Certificate Program, Data Processing - Junior Programming
Translational Drug Development (TD2) May 2015 - Present
Advance Research Associates March 2015 - April 2015
Cerexa December 2013 - November 2014
Janssen Alzheimer Immunotherapy January 2010 - April 2013
Elan Pharmaceuticals March 2008 - December 2009
ADVANCED BIO-LOGICS SOLUTIONS CORP November 2007 - February 2008
Amgen 2002 - November 2007
Immunex 1991 - 2002
BAXTER HEALTHCARE NOVACOR DIVISION 1989 - 1991
World Saving and Loan 1984 - 1990
Skills
21 CFR Part 11, Clinical Development, GCP, CTMS, CDISC, Oncology, Clinical Trials, Sop, Validation, Biotechnology, FDA, Oracle Clinical, Clinical Data Management, Pharmaceutical Industry, Data Management, Lifesciences, EDC, Regulatory Affairs, CRO, Clinical Research, Medidata, Computer System..., ICH-GCP, Medical Devices, GxP, Protocol
Education
Society for Clinical Data Managment 2013 — 2013
Certified Clinical Data Manager
University of Phoenix 2001 — 2003
Bachelor's degree, Information Technology
Heald Business College 1983 — 1984
Certificate Program, Data Processing - Junior Programming
Kristen Mayo, PhD's Janssen Alzheimer Immunotherapy Experience May 2010 - April 2013
Job Owner and Principal Medical Writer at Kristen A. Mayo, PhD, LLC
Industry Pharmaceuticals
Experience
Kristen A. Mayo, PhD, LLC November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2010 - April 2013
Astex Therapeutics 2013 - 2013
AMWA networking 1998 - 2013
FibroGen November 2008 - May 2010
Anesiva, Inc. April 2007 - November 2008
PDL BioPharma 2001 - 2007
ALZA Corporation 2000 - 2000
Clontech 1992 - 1998
Skills
Clinical Trials, Medical Writing, Clinical Development, Biotechnology, Regulatory Submissions, IND, Protocol, eCTD, Drug Development, Immunology, Sop, GCP, Manuscript, Cancer, Medical Affairs, Clinical Study Design, Pharmaceutical Industry, FDA
Education
University of California, Santa Barbara
BA, PhD, English, Biology
Kristen A. Mayo, PhD, LLC November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2010 - April 2013
Astex Therapeutics 2013 - 2013
AMWA networking 1998 - 2013
FibroGen November 2008 - May 2010
Anesiva, Inc. April 2007 - November 2008
PDL BioPharma 2001 - 2007
ALZA Corporation 2000 - 2000
Clontech 1992 - 1998
Skills
Clinical Trials, Medical Writing, Clinical Development, Biotechnology, Regulatory Submissions, IND, Protocol, eCTD, Drug Development, Immunology, Sop, GCP, Manuscript, Cancer, Medical Affairs, Clinical Study Design, Pharmaceutical Industry, FDA
Education
University of California, Santa Barbara
BA, PhD, English, Biology
Bill Hansen's Janssen Alzheimer Immunotherapy Experience January 2010 - May 2013
Job Boehringer Ingelheim Clinical Outsourcing Quality Management
Industry Pharmaceuticals
Experience
Boehringer Ingelheim June 2013 - Present
Janssen Alzheimer Immunotherapy January 2010 - May 2013
MAP Pharmaceuticals October 2009 - January 2010
InterMune March 2002 - July 2009
Roche Pharmaceuticals August 2000 - November 2001
Genentech, Inc. 1997 - August 2000
US Navy June 1988 - October 1993
Skills
Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, Biotechnology, Oncology, GCP, Clinical Research, Lifesciences, FDA, Sop, Vaccines, Drug Development, Regulatory Affairs, EDC, Biopharmaceuticals
Education
Golden Gate University 2007 — 2009
MBA
University of Nebraska at Omaha 1996 — 1997
MA
University of Nebraska-Lincoln 1984 — 1988
BA
Boehringer Ingelheim June 2013 - Present
Janssen Alzheimer Immunotherapy January 2010 - May 2013
MAP Pharmaceuticals October 2009 - January 2010
InterMune March 2002 - July 2009
Roche Pharmaceuticals August 2000 - November 2001
Genentech, Inc. 1997 - August 2000
US Navy June 1988 - October 1993
Skills
Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, Biotechnology, Oncology, GCP, Clinical Research, Lifesciences, FDA, Sop, Vaccines, Drug Development, Regulatory Affairs, EDC, Biopharmaceuticals
Education
Golden Gate University 2007 — 2009
MBA
University of Nebraska at Omaha 1996 — 1997
MA
University of Nebraska-Lincoln 1984 — 1988
BA
Erica Omundsen's Janssen Alzheimer Immunotherapy Experience 2011 - December 2012
Job Experienced professional in clinical data management
Industry Biotechnology
Experience
Prothena Corporation plc July 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2014 - July 2015
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2012 - August 2014
Janssen Alzheimer Immunotherapy 2011 - December 2012
FibroGen, Inc. 2006 - 2011
Gilead Sciences, Inc. 2002 - 2006
Pfizer 1999 - 2002
Parexel 1997 - 1999
Salzburg Seminar 1997 - 1997
Harvard Medical School 1996 - 1997
Education
University of California, Santa Cruz 2002 — 2003
Certificate
Middlebury College 1990 — 1994
B.A.
Universidad de Salamanca 1993 — 1993
Prothena Corporation plc July 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2014 - July 2015
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2012 - August 2014
Janssen Alzheimer Immunotherapy 2011 - December 2012
FibroGen, Inc. 2006 - 2011
Gilead Sciences, Inc. 2002 - 2006
Pfizer 1999 - 2002
Parexel 1997 - 1999
Salzburg Seminar 1997 - 1997
Harvard Medical School 1996 - 1997
Education
University of California, Santa Cruz 2002 — 2003
Certificate
Middlebury College 1990 — 1994
B.A.
Universidad de Salamanca 1993 — 1993
Jane Datangel, RN's Janssen Alzheimer Immunotherapy Experience November 2011 - February 2013
Job
Industry Biotechnology
Experience
Jazz Pharmaceuticals August 2014 - Present
Threshold Pharmaceuticals February 2013 - August 2014
JANSSEN Alzheimer Immunotherapy November 2011 - February 2013
Actelion April 2011 - November 2011
Genentech March 2006 - February 2011
Northern California Institute for Research and Education April 2002 - March 2006
El Camino Hospital / Evergreen Dialysis January 1999 - July 2002
VA Medical Center, Palo Alto April 2001 - April 2002
UCSF Medical Center August 1998 - November 1998
Skills
Clinical Research, Clinical Trials, CTMS, Oncology, GCP, EDC, Clinical Development, Drug Safety, Cardiology, Pharmacovigilance, ICH-GCP, Clinical Data Management, Medical Writing, Clinical Monitoring, Regulatory Submissions, CRO, Infectious Diseases, Therapeutic Areas
Education
San Jose State University
Bachelor of Science
Jazz Pharmaceuticals August 2014 - Present
Threshold Pharmaceuticals February 2013 - August 2014
JANSSEN Alzheimer Immunotherapy November 2011 - February 2013
Actelion April 2011 - November 2011
Genentech March 2006 - February 2011
Northern California Institute for Research and Education April 2002 - March 2006
El Camino Hospital / Evergreen Dialysis January 1999 - July 2002
VA Medical Center, Palo Alto April 2001 - April 2002
UCSF Medical Center August 1998 - November 1998
Skills
Clinical Research, Clinical Trials, CTMS, Oncology, GCP, EDC, Clinical Development, Drug Safety, Cardiology, Pharmacovigilance, ICH-GCP, Clinical Data Management, Medical Writing, Clinical Monitoring, Regulatory Submissions, CRO, Infectious Diseases, Therapeutic Areas
Education
San Jose State University
Bachelor of Science
Shyra Gardai's Janssen Alzheimer Immunotherapy Experience January 2009 - November 2012
Job Principal Scientist at Seattle Genetics
Industry Biotechnology
Experience
Seattle Genetics December 2013 - Present
Second Genome, Inc. May 2013 - December 2013
Elan Pharmaceuticals October 2006 - December 2012
JANSSEN Alzheimer Immunotherapy January 2009 - November 2012
University of Colorado Heath Science Center September 2005 - October 2006
National Jewish Medical and Research Center May 2002 - September 2005
University of Colorado Health Sciences Center January 1997 - January 2002
Skills
immunology, cell biolgy, fluorescence microscopy, Flow Cytometry, Assay Development, Cell, Drug Discovery, thearapeutic antibody..., Immunology, Antibodies, Fluorescence Microscopy, Western Blotting, Molecular Biology, Tissue Culture, Bioinformatics, Biomarkers, Microarray Analysis, Protein Chemistry, Immunofluorescence, Immunoprecipitation, Biochemistry, Neuroscience, Clinical Research, Neurodegeneration, Cell Biology, Target Identification, Neurodegenerative...
Education
University of Colorado Anschutz Medical Campus 1997 — 2002
Ph.D., Innate Immunity
University of Idaho 1993 — 1997
B.S., Biochemistry/microbiology
Seattle Genetics December 2013 - Present
Second Genome, Inc. May 2013 - December 2013
Elan Pharmaceuticals October 2006 - December 2012
JANSSEN Alzheimer Immunotherapy January 2009 - November 2012
University of Colorado Heath Science Center September 2005 - October 2006
National Jewish Medical and Research Center May 2002 - September 2005
University of Colorado Health Sciences Center January 1997 - January 2002
Skills
immunology, cell biolgy, fluorescence microscopy, Flow Cytometry, Assay Development, Cell, Drug Discovery, thearapeutic antibody..., Immunology, Antibodies, Fluorescence Microscopy, Western Blotting, Molecular Biology, Tissue Culture, Bioinformatics, Biomarkers, Microarray Analysis, Protein Chemistry, Immunofluorescence, Immunoprecipitation, Biochemistry, Neuroscience, Clinical Research, Neurodegeneration, Cell Biology, Target Identification, Neurodegenerative...
Education
University of Colorado Anschutz Medical Campus 1997 — 2002
Ph.D., Innate Immunity
University of Idaho 1993 — 1997
B.S., Biochemistry/microbiology
Marc Nicholson's Janssen Alzheimer Immunotherapy Experience September 2011 - Present
Job Category Manager at JANSSEN Research and Development
Industry Medical Devices
Experience
JANSSEN Alzheimer Immunotherapy September 2011 - Present
MicroDental Laboratories December 2009 - August 2011
Celera Diagnostics November 2007 - February 2010
ALZA / Johnson & Johnson February 2006 - November 2007
Cell Genesys 2004 - 2006
LifeScan March 2000 - March 2004
Skills
Strategic Sourcing, Procurement, Contract Negotiation, Supply Management, Cross-functional Team..., Supply Chain Management, GMP, Global Sourcing, Management, Manufacturing, Project Management, Purchasing, SAP, Sop, Sourcing, Supervisory Management, Supply Chain
Education
California State University-East Bay 1987 — 1991
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
California State University-Hayward 1987 — 1991
Bachelor of Arts, Biology
JANSSEN Alzheimer Immunotherapy September 2011 - Present
MicroDental Laboratories December 2009 - August 2011
Celera Diagnostics November 2007 - February 2010
ALZA / Johnson & Johnson February 2006 - November 2007
Cell Genesys 2004 - 2006
LifeScan March 2000 - March 2004
Skills
Strategic Sourcing, Procurement, Contract Negotiation, Supply Management, Cross-functional Team..., Supply Chain Management, GMP, Global Sourcing, Management, Manufacturing, Project Management, Purchasing, SAP, Sop, Sourcing, Supervisory Management, Supply Chain
Education
California State University-East Bay 1987 — 1991
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
California State University-Hayward 1987 — 1991
Bachelor of Arts, Biology
Linda Baher's Janssen Alzheimer Immunotherapy Experience July 2011 - November 2012
Job Director, Clinical Operations at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics December 2012 - Present
Janssen Alzheimer Immunotherapy July 2011 - November 2012
Roche Pharmaceuticals March 2010 - May 2011
Roche Pharmaceuticals August 2008 - February 2010
Roche Pharmaceuticals April 2003 - August 2008
International AIDS Vaccine Initiative December 2002 - March 2003
MedImmune 1999 - 2002
Barnett Educational Services 1996 - 1999
PAREXEL 1992 - 1996
Peace Corps 1989 - 1992
Skills
Alzheimer's disease, Influenza, Hepatitis C, Clinical Trials, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Biotechnology, CTMS, Program Management, Project Management, Protocol Development, HIV, SOP Development, ICH-GCP, Medidata, MS Project, Protocol, GCP, 21 CFR Part 11, Regulatory Submissions, FDA, Clinical Study Design, Oncology, Clinical Monitoring, Sop, Diabetes, Biopharmaceuticals, Clinical Pharmacology, Drug Development, Cardiology, Cancer, IND, Therapeutic Areas, SOP
Education
University of Minnesota-Twin Cities
Bachelor of Science
Pharmacyclics December 2012 - Present
Janssen Alzheimer Immunotherapy July 2011 - November 2012
Roche Pharmaceuticals March 2010 - May 2011
Roche Pharmaceuticals August 2008 - February 2010
Roche Pharmaceuticals April 2003 - August 2008
International AIDS Vaccine Initiative December 2002 - March 2003
MedImmune 1999 - 2002
Barnett Educational Services 1996 - 1999
PAREXEL 1992 - 1996
Peace Corps 1989 - 1992
Skills
Alzheimer's disease, Influenza, Hepatitis C, Clinical Trials, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Biotechnology, CTMS, Program Management, Project Management, Protocol Development, HIV, SOP Development, ICH-GCP, Medidata, MS Project, Protocol, GCP, 21 CFR Part 11, Regulatory Submissions, FDA, Clinical Study Design, Oncology, Clinical Monitoring, Sop, Diabetes, Biopharmaceuticals, Clinical Pharmacology, Drug Development, Cardiology, Cancer, IND, Therapeutic Areas, SOP
Education
University of Minnesota-Twin Cities
Bachelor of Science
Greg Kosanovich's Janssen Alzheimer Immunotherapy Experience November 2010 - October 2011
Job Consultant, Data Management at Genentech
Industry Pharmaceuticals
Experience
Genentech October 2011 - Present
JANSSEN Alzheimer Immunotherapy November 2010 - October 2011
Jazz Pharmaceuticals November 2009 - December 2010
W.L. Gore & Associates November 2007 - July 2010
Amgen 2006 - 2007
ALZA Corporation 2003 - 2006
Somnus Medical Technologies 1999 - 2001
Education
State University of New York College at Buffalo 1990 — 1998
BA, MA, Biology, Molecular Biology
Genentech October 2011 - Present
JANSSEN Alzheimer Immunotherapy November 2010 - October 2011
Jazz Pharmaceuticals November 2009 - December 2010
W.L. Gore & Associates November 2007 - July 2010
Amgen 2006 - 2007
ALZA Corporation 2003 - 2006
Somnus Medical Technologies 1999 - 2001
Education
State University of New York College at Buffalo 1990 — 1998
BA, MA, Biology, Molecular Biology
Christian Nebel's Janssen Alzheimer Immunotherapy Experience April 2010 - Present
Job Pharmaceutical Strategic Marketing
Industry Pharmaceuticals
Experience
JANSSEN Alzheimer Immunotherapy April 2010 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2008 - March 2010
Janssen, Pharmaceutical Companies of Johnson and Johnson February 2006 - March 2008
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2004 - February 2006
IBM Business Consulting Services 2002 - 2004
PricewaterhouseCoopers, LLP 1998 - 2002
Schering 1996 - 1997
Curtiss-Wright Corporation 1993 - 1996
Skills
Pharmaceutical Industry, Market Access, Global Marketing, Health Economics, Medical Devices, Managed Care, Biotechnology, Product Launch, Clinical Trials, Business Strategy, Business Analysis, Financial Analysis, Product Marketing, Business Valuation, DCF Valuation, Change Management, Business Transformation, Business Process..., New Business Development, Business Model..., Portfolio Management, Management Consulting, Project Management, Strategic Partnerships, Strategic Alliances, Thought Leadership
Education
New York University - Leonard N. Stern School of Business 1996 — 1998
Master of Business Administration (M.B.A.), Finance, General
Lehigh University 1989 — 1993
BS, Industrial Engineering
JANSSEN Alzheimer Immunotherapy April 2010 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2008 - March 2010
Janssen, Pharmaceutical Companies of Johnson and Johnson February 2006 - March 2008
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2004 - February 2006
IBM Business Consulting Services 2002 - 2004
PricewaterhouseCoopers, LLP 1998 - 2002
Schering 1996 - 1997
Curtiss-Wright Corporation 1993 - 1996
Skills
Pharmaceutical Industry, Market Access, Global Marketing, Health Economics, Medical Devices, Managed Care, Biotechnology, Product Launch, Clinical Trials, Business Strategy, Business Analysis, Financial Analysis, Product Marketing, Business Valuation, DCF Valuation, Change Management, Business Transformation, Business Process..., New Business Development, Business Model..., Portfolio Management, Management Consulting, Project Management, Strategic Partnerships, Strategic Alliances, Thought Leadership
Education
New York University - Leonard N. Stern School of Business 1996 — 1998
Master of Business Administration (M.B.A.), Finance, General
Lehigh University 1989 — 1993
BS, Industrial Engineering
Anna Shadman's Janssen Alzheimer Immunotherapy Experience September 2009 - July 2012
Job VP, Compound Development Team Leader
Industry Pharmaceuticals
Experience
Janssen Alzheimer Immunotherapy (J&J) October 2011 - Present
JANSSEN Alzheimer Immunotherapy September 2009 - July 2012
Johnson & Johnson November 2005 - September 2009
Quintiles Transnational Corp. 1999 - 2005
Otsuka 1994 - 1999
Syntex Research 1986 - 1994
Skills
Global Drug Development, Compound Development..., Clinical Trials, Project Management, Management, Biostatistics, Clinical Data Management, Business Development, Clinical Research, Biotechnology, CRO, Clinical Development, GCP, Data Management, Pharmaceutical Industry, Regulatory Affairs, Oncology, Regulatory Submissions, Immunology, CTMS, Lifesciences, EDC, FDA, 21 CFR Part 11, Pharmacovigilance, Drug Development, Therapeutic Areas, Biopharmaceuticals, Medical Writing
Education
London School of Hygiene and Tropical Medicine, U. of London 1983 — 1984
Master of Science (M.Sc.), Medical Statistics
University of Sussex 1980 — 1984
Bachelor of Science (B.Sc.), Mathematics
Janssen Alzheimer Immunotherapy (J&J) October 2011 - Present
JANSSEN Alzheimer Immunotherapy September 2009 - July 2012
Johnson & Johnson November 2005 - September 2009
Quintiles Transnational Corp. 1999 - 2005
Otsuka 1994 - 1999
Syntex Research 1986 - 1994
Skills
Global Drug Development, Compound Development..., Clinical Trials, Project Management, Management, Biostatistics, Clinical Data Management, Business Development, Clinical Research, Biotechnology, CRO, Clinical Development, GCP, Data Management, Pharmaceutical Industry, Regulatory Affairs, Oncology, Regulatory Submissions, Immunology, CTMS, Lifesciences, EDC, FDA, 21 CFR Part 11, Pharmacovigilance, Drug Development, Therapeutic Areas, Biopharmaceuticals, Medical Writing
Education
London School of Hygiene and Tropical Medicine, U. of London 1983 — 1984
Master of Science (M.Sc.), Medical Statistics
University of Sussex 1980 — 1984
Bachelor of Science (B.Sc.), Mathematics
Iulia Cristina Tudor's Janssen Alzheimer Immunotherapy Experience January 2011 - 2013
Job Associate Director Biostatistics at Medivation
Industry Pharmaceuticals
Experience
Medivation May 2013 - Present
JANSSEN Alzheimer Immunotherapy January 2011 - 2013
Genentech September 2008 - January 2011
ALZA Corporation/Johnson & Johnson August 2005 - August 2008
Ischemia Research and Education Foundation (IREF) May 2001 - August 2005
Skills
Clinical Development, Clinical Trials, Biostatistics, Oncology, Regulatory Submissions, Clinical Study Design, Pharmaceutical Industry, Biotechnology, CRO, GCP, Clinical Research, Drug Development, Adaptive Learning, Statistical Programming, Medical Writing, SAS programming, Infectious Diseases, Clinical Data Management, Biomarkers, EDC, CTMS, SDTM
Education
Center for Mathematical Statistics of the Romanian Academy 1994 — 1998
Ph.D.
Université Pierre et Marie Curie (Paris VI)
MS
University of Bucharest
BS
Medivation May 2013 - Present
JANSSEN Alzheimer Immunotherapy January 2011 - 2013
Genentech September 2008 - January 2011
ALZA Corporation/Johnson & Johnson August 2005 - August 2008
Ischemia Research and Education Foundation (IREF) May 2001 - August 2005
Skills
Clinical Development, Clinical Trials, Biostatistics, Oncology, Regulatory Submissions, Clinical Study Design, Pharmaceutical Industry, Biotechnology, CRO, GCP, Clinical Research, Drug Development, Adaptive Learning, Statistical Programming, Medical Writing, SAS programming, Infectious Diseases, Clinical Data Management, Biomarkers, EDC, CTMS, SDTM
Education
Center for Mathematical Statistics of the Romanian Academy 1994 — 1998
Ph.D.
Université Pierre et Marie Curie (Paris VI)
MS
University of Bucharest
BS
Jeanette Gilbert's Janssen Alzheimer Immunotherapy Experience July 2010 - March 2013
Job Global Trial Manager/Clinical Trial Manager
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2013 - Present
JANSSEN Alzheimer Immunotherapy July 2010 - March 2013
ProTrials Research November 2005 - July 2010
Perlegen Sciences April 2005 - November 2005
Skills
GCP, Clinical Development, Oncology, Biotechnology, CRO, CTMS, EDC, Clinical Research, Pharmaceutical Industry, Lifesciences, Clinical Monitoring, FDA, Infectious Diseases, Sop, Clinical Data Management, Clinical Operations, ICH-GCP, Drug Development, Alzheimer's disease
Education
San Jose State University 2012 — 2015
Master of Science (M.S.)
Sonoma State University 2000 — 2004
Bachelor of Arts (BA), Microbiology, General
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2013 - Present
JANSSEN Alzheimer Immunotherapy July 2010 - March 2013
ProTrials Research November 2005 - July 2010
Perlegen Sciences April 2005 - November 2005
Skills
GCP, Clinical Development, Oncology, Biotechnology, CRO, CTMS, EDC, Clinical Research, Pharmaceutical Industry, Lifesciences, Clinical Monitoring, FDA, Infectious Diseases, Sop, Clinical Data Management, Clinical Operations, ICH-GCP, Drug Development, Alzheimer's disease
Education
San Jose State University 2012 — 2015
Master of Science (M.S.)
Sonoma State University 2000 — 2004
Bachelor of Arts (BA), Microbiology, General
Tammy Rose's Janssen Alzheimer Immunotherapy Experience July 2012 - November 2012
Job Regulatory Program Director at Genentech
Industry Biotechnology
Experience
Genentech March 2014 - Present
Genentech November 2012 - Present
JANSSEN Alzheimer Immunotherapy July 2012 - November 2012
Amgen March 2011 - July 2012
Amgen September 2008 - March 2011
Amgen June 2005 - September 2008
Skills
Regulatory Affairs, Regulatory Submissions, IND, Biopharmaceuticals, Clinical Development, FDA, Drug Development
Education
California State University-Bakersfield
Bachelor of Science (B.S.)
Genentech March 2014 - Present
Genentech November 2012 - Present
JANSSEN Alzheimer Immunotherapy July 2012 - November 2012
Amgen March 2011 - July 2012
Amgen September 2008 - March 2011
Amgen June 2005 - September 2008
Skills
Regulatory Affairs, Regulatory Submissions, IND, Biopharmaceuticals, Clinical Development, FDA, Drug Development
Education
California State University-Bakersfield
Bachelor of Science (B.S.)
Hervé Bruckert's Janssen Alzheimer Immunotherapy Experience 2011 - September 2013
Job Divisional Finance Leader at UC Berkeley
Industry Accounting
Experience
UC Berkeley October 2013 - Present
De Novo Wines 2006 - 2015
JANSSEN Alzheimer Immunotherapy 2011 - September 2013
Premier Nutrition 2013 - 2013
Robert Half International 2011 - 2013
Chevron 2009 - 2011
ALZA Corporation January 2007 - January 2009
Kaiser Permanente January 2004 - January 2007
Teknion January 2002 - January 2004
Steelcase January 1992 - December 2001
Skills
Financial Analysis, Project Finance, Activity Based Costing, Forecasting, Financial Modeling, Finance, Budgets, Process Improvement, Strategic Planning, Project Management, Business Strategy, Financial Reporting, Cross-functional Team..., Accounting, Business Analysis, Sarbanes-Oxley Act, Auditing, Internal Controls, Leadership, Project Planning, Risk Management, Management, Management Consulting, Strategy, CRM, Managerial Finance
Education
University of San Francisco - Masagung Graduate School of Management 2001 — 2003
EMBA
UC Berkeley October 2013 - Present
De Novo Wines 2006 - 2015
JANSSEN Alzheimer Immunotherapy 2011 - September 2013
Premier Nutrition 2013 - 2013
Robert Half International 2011 - 2013
Chevron 2009 - 2011
ALZA Corporation January 2007 - January 2009
Kaiser Permanente January 2004 - January 2007
Teknion January 2002 - January 2004
Steelcase January 1992 - December 2001
Skills
Financial Analysis, Project Finance, Activity Based Costing, Forecasting, Financial Modeling, Finance, Budgets, Process Improvement, Strategic Planning, Project Management, Business Strategy, Financial Reporting, Cross-functional Team..., Accounting, Business Analysis, Sarbanes-Oxley Act, Auditing, Internal Controls, Leadership, Project Planning, Risk Management, Management, Management Consulting, Strategy, CRM, Managerial Finance
Education
University of San Francisco - Masagung Graduate School of Management 2001 — 2003
EMBA
Shailaja Lakma's Janssen Alzheimer Immunotherapy Experience October 2011 - April 2012
Job Clinical Research Assistant at ProTrials Research
Industry Biotechnology
Experience
JANSSEN Alzheimer Immunotherapy October 2011 - April 2012
ProTrials Research 2012 - 2012
Abbott Vascular November 2010 - October 2011
Alpha Laboraratories March 2009 - April 2010
Education
Bangalore University
UCSC Extension
JANSSEN Alzheimer Immunotherapy October 2011 - April 2012
ProTrials Research 2012 - 2012
Abbott Vascular November 2010 - October 2011
Alpha Laboraratories March 2009 - April 2010
Education
Bangalore University
UCSC Extension
Lillian Mock's Janssen Alzheimer Immunotherapy Experience May 2012 - March 2013
Job Clinical Trial Manager at Puma Biotechnology, Inc.
Industry Research
Experience
Puma Biotechnology, Inc. March 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2012 - March 2013
Gilead Sciences August 2010 - May 2012
Exelixis May 2007 - August 2010
Exelixis February 2001 - May 2007
Incyte Pharmaceuticals July 1999 - February 2001
Genentech June 1999 - July 1999
Skills
High Throughput..., IND, Drug Discovery, Clinical Development, Personalized Medicine, Translational Research, Pharmacodynamics, Clinical Operations, Oncology, Biotechnology, CTMS, Clinical Trials, GCP, CRO, Clinical Data Management, Clinical Research, Infectious Diseases, Cancer, EDC, Clinical Monitoring, Immunology, ICH-GCP
Education
UCSC Extension 2006 — 2007
Certificate, Clinical Trial Design and Management
San Francisco State University 1994 — 1999
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
Puma Biotechnology, Inc. March 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2012 - March 2013
Gilead Sciences August 2010 - May 2012
Exelixis May 2007 - August 2010
Exelixis February 2001 - May 2007
Incyte Pharmaceuticals July 1999 - February 2001
Genentech June 1999 - July 1999
Skills
High Throughput..., IND, Drug Discovery, Clinical Development, Personalized Medicine, Translational Research, Pharmacodynamics, Clinical Operations, Oncology, Biotechnology, CTMS, Clinical Trials, GCP, CRO, Clinical Data Management, Clinical Research, Infectious Diseases, Cancer, EDC, Clinical Monitoring, Immunology, ICH-GCP
Education
UCSC Extension 2006 — 2007
Certificate, Clinical Trial Design and Management
San Francisco State University 1994 — 1999
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
Apollo Madayag's Janssen Alzheimer Immunotherapy Experience November 2011 - March 2013
Job Global Studies Manager PDG Oncology Genentech
Industry Biotechnology
Experience
Genentech March 2015 - Present
Gilead Sciences February 2014 - February 2015
Gilead Sciences April 2013 - January 2014
JANSSEN Alzheimer Immunotherapy November 2011 - March 2013
Amgen March 2010 - December 2010
Abbott Vascular June 2009 - July 2009
Boston Scientific June 2003 - January 2008
Enteric Medical Technologies, Inc. November 2000 - May 2003
Skills
CTMS, Biotechnology, Clinical Research, Lifesciences, Oncology, Hematology, Clinical Trials, GCP, Clinical Development, EDC, CRO, Pharmaceutical Industry, Clinical Monitoring, Immunology, Endocrinology, FDA, Clinical Data Management, Clinical Operations, Drug Development, ICH-GCP, Life Sciences, Protocol, Regulatory Submissions
Education
University of California, Davis
Bachelor of Science (B.S.), Psychology (emphasis in Biology)
Genentech March 2015 - Present
Gilead Sciences February 2014 - February 2015
Gilead Sciences April 2013 - January 2014
JANSSEN Alzheimer Immunotherapy November 2011 - March 2013
Amgen March 2010 - December 2010
Abbott Vascular June 2009 - July 2009
Boston Scientific June 2003 - January 2008
Enteric Medical Technologies, Inc. November 2000 - May 2003
Skills
CTMS, Biotechnology, Clinical Research, Lifesciences, Oncology, Hematology, Clinical Trials, GCP, Clinical Development, EDC, CRO, Pharmaceutical Industry, Clinical Monitoring, Immunology, Endocrinology, FDA, Clinical Data Management, Clinical Operations, Drug Development, ICH-GCP, Life Sciences, Protocol, Regulatory Submissions
Education
University of California, Davis
Bachelor of Science (B.S.), Psychology (emphasis in Biology)
Quoc M.'s Janssen Alzheimer Immunotherapy Experience October 2011 - August 2012
Job Manager, Statistical Programming
Industry Pharmaceuticals
Experience
Pharmacyclics September 2015 - Present
Roche Molecular Systems October 2013 - August 2015
Abbott Medical Optics August 2012 - October 2013
JANSSEN Alzheimer Immunotherapy October 2011 - August 2012
sanofi-aventis June 2010 - September 2011
Onyx Pharmaceuticals January 2010 - June 2010
Biopharm Systems August 2006 - December 2009
Allergan February 2008 - June 2009
Medtronic September 2006 - February 2008
Valeant Pharmaceuticals April 2003 - August 2006
Skills
SAS, Oracle Clinical, CDISC SDTM & ADAM, .NET, MS-SQL, Oncology, Medical Devices, Infectious Diseases, Ophthalmology, Data Management, Biostatistics, FDA Submission, SDLC, IQ/OQ/PQ, Process Optimization, Lean 6 Sigma, Risk Management, Project Management, Problem Solving, SOP development, Communication, Documentations, Presentations, Training, Microsoft SQL Server, 21 CFR Part 11, SDTM, Clinical Trials, Clinical Data Management, Electronic Data..., Datafax
Education
University of Hawaii at Manoa 1995 — 2002
BS, Computer Science
Roosevel HS
Pharmacyclics September 2015 - Present
Roche Molecular Systems October 2013 - August 2015
Abbott Medical Optics August 2012 - October 2013
JANSSEN Alzheimer Immunotherapy October 2011 - August 2012
sanofi-aventis June 2010 - September 2011
Onyx Pharmaceuticals January 2010 - June 2010
Biopharm Systems August 2006 - December 2009
Allergan February 2008 - June 2009
Medtronic September 2006 - February 2008
Valeant Pharmaceuticals April 2003 - August 2006
Skills
SAS, Oracle Clinical, CDISC SDTM & ADAM, .NET, MS-SQL, Oncology, Medical Devices, Infectious Diseases, Ophthalmology, Data Management, Biostatistics, FDA Submission, SDLC, IQ/OQ/PQ, Process Optimization, Lean 6 Sigma, Risk Management, Project Management, Problem Solving, SOP development, Communication, Documentations, Presentations, Training, Microsoft SQL Server, 21 CFR Part 11, SDTM, Clinical Trials, Clinical Data Management, Electronic Data..., Datafax
Education
University of Hawaii at Manoa 1995 — 2002
BS, Computer Science
Roosevel HS
Lorna Fang's Janssen Alzheimer Immunotherapy Experience September 2009 - October 2012
Job Senior Manager, Statistical Programming at Onyx Pharmaceuticals
Industry Biotechnology
Experience
Onyx Pharmaceuticals November 2013 - Present
Gilead Sciences October 2012 - November 2013
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Elan January 2008 - September 2009
Amylin Pharmaceuticals, Inc. February 2007 - January 2008
Abbott Labs March 2005 - February 2007
Skills
SAS, Statistical Programming, CDISC, Biostatistics, EDC, Clinical Data Management, SAS programming, Clinical Trials, Survival Analysis, CRO, Clinical Development, Oracle Clinical, GCP, SAS Programming, 21 CFR Part 11
Education
The University of Texas at Arlington 2003 — 2004
Master, Statistics
Onyx Pharmaceuticals November 2013 - Present
Gilead Sciences October 2012 - November 2013
JANSSEN Alzheimer Immunotherapy September 2009 - October 2012
Elan January 2008 - September 2009
Amylin Pharmaceuticals, Inc. February 2007 - January 2008
Abbott Labs March 2005 - February 2007
Skills
SAS, Statistical Programming, CDISC, Biostatistics, EDC, Clinical Data Management, SAS programming, Clinical Trials, Survival Analysis, CRO, Clinical Development, Oracle Clinical, GCP, SAS Programming, 21 CFR Part 11
Education
The University of Texas at Arlington 2003 — 2004
Master, Statistics
Joyce Guerrero's Janssen Alzheimer Immunotherapy Experience June 2011 - February 2013
Job Research Assistant at Genentech
Industry Pharmaceuticals
Experience
Genentech November 2013 - Present
JANSSEN Alzheimer Immunotherapy June 2011 - February 2013
Elan Pharmaceuticals January 2005 - January 2011
Skills
GMP, ELISA, HPLC, Validation, Sop, SDS-PAGE, Assay Development, Biotechnology, Bioanalysis, GLP, LIMS, Biopharmaceuticals, Immunology
Education
San Francisco State University 1998 — 2003
BS, Microbiology
Genentech November 2013 - Present
JANSSEN Alzheimer Immunotherapy June 2011 - February 2013
Elan Pharmaceuticals January 2005 - January 2011
Skills
GMP, ELISA, HPLC, Validation, Sop, SDS-PAGE, Assay Development, Biotechnology, Bioanalysis, GLP, LIMS, Biopharmaceuticals, Immunology
Education
San Francisco State University 1998 — 2003
BS, Microbiology
Brian (BK) King's Janssen Alzheimer Immunotherapy Experience December 2010 - December 2011
Job Senior Clinical Trial Manager, Medical Affairs at Ultragenyx Pharmaceutical Inc.
Industry Biotechnology
Experience
Ultragenyx Pharmaceutical Inc. January 2015 - Present
Ultragenyx Pharmaceutical Inc. February 2013 - December 2014
JANSSEN Alzheimer Immunotherapy December 2010 - December 2011
Elan Pharmaceuticals April 2008 - December 2010
Genentech October 2003 - April 2007
Genentech November 2001 - October 2003
Skills
Biotechnology, Clinical Development, Clinical Trials, 21 CFR Part 11, CTMS, Oncology, CRO, GCP, Drug Development, Life Sciences, FDA
Education
University of California, Davis 1996 — 2000
Bachelor of Science, Biological Engineering
Ultragenyx Pharmaceutical Inc. January 2015 - Present
Ultragenyx Pharmaceutical Inc. February 2013 - December 2014
JANSSEN Alzheimer Immunotherapy December 2010 - December 2011
Elan Pharmaceuticals April 2008 - December 2010
Genentech October 2003 - April 2007
Genentech November 2001 - October 2003
Skills
Biotechnology, Clinical Development, Clinical Trials, 21 CFR Part 11, CTMS, Oncology, CRO, GCP, Drug Development, Life Sciences, FDA
Education
University of California, Davis 1996 — 2000
Bachelor of Science, Biological Engineering
Frances Pena's Janssen Alzheimer Immunotherapy Experience March 2011 - April 2013
Job Sr. Administrative Assoc/Project Coordinator
Industry Biotechnology
Experience
Genentech June 2013 - Present
JANSSEN Alzheimer Immunotherapy March 2011 - April 2013
Genentech November 2009 - January 2011
BERRY, APPLEMAN & LEIDEN LLC December 2005 - April 2009
Applera Corporation (Applied Biosystems) January 2000 - September 2005
Skills
Microsoft Office, Outlook, Human Resources, Research, Microsoft Excel, Customer Service, PowerPoint, Employee Relations, Project Coordination, Superior Client Service, Administrative Office..., Administrative Staffing, Administrative..., I-9 Compliance, Immigration Specialist, E-Verify, Microsoft Word, IRIS, ADP Payroll, Totality, GXRS, Ariba, Live Meeting, InterCall (audio), Google Calendar, SRM 5.0, AmexTravel, MOS, SharePoint, Social Events, Calendars, Event Planning, Management, Time Management
Education
College of San Mateo 1994 — 1995
General Education
Genentech June 2013 - Present
JANSSEN Alzheimer Immunotherapy March 2011 - April 2013
Genentech November 2009 - January 2011
BERRY, APPLEMAN & LEIDEN LLC December 2005 - April 2009
Applera Corporation (Applied Biosystems) January 2000 - September 2005
Skills
Microsoft Office, Outlook, Human Resources, Research, Microsoft Excel, Customer Service, PowerPoint, Employee Relations, Project Coordination, Superior Client Service, Administrative Office..., Administrative Staffing, Administrative..., I-9 Compliance, Immigration Specialist, E-Verify, Microsoft Word, IRIS, ADP Payroll, Totality, GXRS, Ariba, Live Meeting, InterCall (audio), Google Calendar, SRM 5.0, AmexTravel, MOS, SharePoint, Social Events, Calendars, Event Planning, Management, Time Management
Education
College of San Mateo 1994 — 1995
General Education
Greg Kosanovich's Janssen Alzheimer Immunotherapy Experience October 2010 - October 2011
Job Manager, CDM at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics October 2012 - Present
Genentech October 2011 - October 2012
JANSSEN Alzheimer Immunotherapy October 2010 - October 2011
Jazz Pharmaceuticals December 2009 - 2010
W.L. Gore & Associates 2007 - 2009
Amgen 2006 - 2007
Alza 2003 - 2006
Alza 2003 - 2006
ALZA Corporation 2002 - 2006
Skills
Clinical Data Management, Clinical Trials, Data Management, Clinical Research, CDISC, GCP, Validation, EDC, Oncology, Oracle Clinical, CRO, CTMS, Clinical Development, Pharmaceutical Industry, SAS, Medidata, 21 CFR Part 11, Biotechnology, SAS programming, Clinical Study Design, Biostatistics, Databases, Vendor Management, Project Management, SDTM, Statistical Programming, Cancer, SOP development, Data Validation, CRF design, Process Improvement, Pharmaceutical process..., Medical Devices, Contract Management, Contractors, Budget Management, Budget Monitoring, Management, Operations Management, ICH-GCP, SAS Programming, Drug Development, Protocol
Education
Buffalo State College 1996 — 1998
Master's degree, Molecular Biology
Buffalo State College 1987 — 1995
Bachelor's degree, Biology, General
Pharmacyclics October 2012 - Present
Genentech October 2011 - October 2012
JANSSEN Alzheimer Immunotherapy October 2010 - October 2011
Jazz Pharmaceuticals December 2009 - 2010
W.L. Gore & Associates 2007 - 2009
Amgen 2006 - 2007
Alza 2003 - 2006
Alza 2003 - 2006
ALZA Corporation 2002 - 2006
Skills
Clinical Data Management, Clinical Trials, Data Management, Clinical Research, CDISC, GCP, Validation, EDC, Oncology, Oracle Clinical, CRO, CTMS, Clinical Development, Pharmaceutical Industry, SAS, Medidata, 21 CFR Part 11, Biotechnology, SAS programming, Clinical Study Design, Biostatistics, Databases, Vendor Management, Project Management, SDTM, Statistical Programming, Cancer, SOP development, Data Validation, CRF design, Process Improvement, Pharmaceutical process..., Medical Devices, Contract Management, Contractors, Budget Management, Budget Monitoring, Management, Operations Management, ICH-GCP, SAS Programming, Drug Development, Protocol
Education
Buffalo State College 1996 — 1998
Master's degree, Molecular Biology
Buffalo State College 1987 — 1995
Bachelor's degree, Biology, General
Jay Soto's Janssen Alzheimer Immunotherapy Experience April 2011 - January 2013
Job Clinical Operations Lead at Prothena
Industry Biotechnology
Experience
Prothena 2014 - Present
Pharmacyclics 2013 - 2014
JANSSEN Alzheimer Immunotherapy April 2011 - January 2013
Janssen Alzheimer Immunotherpay Research and Development September 2009 - April 2011
Elan Pharmaceuticals April 2008 - September 2009
Education
UCLA
Prothena 2014 - Present
Pharmacyclics 2013 - 2014
JANSSEN Alzheimer Immunotherapy April 2011 - January 2013
Janssen Alzheimer Immunotherpay Research and Development September 2009 - April 2011
Elan Pharmaceuticals April 2008 - September 2009
Education
UCLA
Martha Bye's Janssen Alzheimer Immunotherapy Experience December 2011 - Present
Job Clinical Trial Manager at JANSSEN Alzheimer Immunotherapy
Industry Biotechnology
Experience
JANSSEN Alzheimer Immunotherapy December 2011 - Present
Impax Laboratories April 2011 - December 2011
Affymax July 2009 - May 2011
Johnson & Johnson July 1998 - March 2009
ALZA/Johnson & Johnson 2003 - 2009
QUINTILES PACIFIC, INC., MT. VIEW, CA June 1995 - August 1998
Skills
Clinical Development, CTMS, CRO, GCP, Clinical Trials
Education
Indiana University Bloomington
BS, Medical Technology
JANSSEN Alzheimer Immunotherapy December 2011 - Present
Impax Laboratories April 2011 - December 2011
Affymax July 2009 - May 2011
Johnson & Johnson July 1998 - March 2009
ALZA/Johnson & Johnson 2003 - 2009
QUINTILES PACIFIC, INC., MT. VIEW, CA June 1995 - August 1998
Skills
Clinical Development, CTMS, CRO, GCP, Clinical Trials
Education
Indiana University Bloomington
BS, Medical Technology
Diana Sanderson's Janssen Alzheimer Immunotherapy Experience November 2009 - September 2011
Job President, Sanderson Clinical Consulting, Inc.
Industry Pharmaceuticals
Experience
Edwards Lifesciences December 2013 - Present
Heartflow, Inc February 2014 - April 2015
Medtronic November 2010 - February 2015
St. Jude Medical October 2009 - October 2011
Janssen Alzheimer Immunotherapy November 2009 - September 2011
Genzyme May 2010 - March 2011
Schering-Plough Research Institute May 2010 - July 2010
MedImmune September 2006 - November 2009
Schering-Plough Research Institute April 2009 - October 2009
Nexus Oncology October 2008 - January 2009
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Clinical Research, GCP, Clinical Development, Quality Assurance, ICH-GCP, Regulatory Affairs, Clinical Monitoring, FDA, Strategic Planning, Oncology, Regulatory Requirements, EDC, Pharmacovigilance, Protocol
Education
Sarah Lawrence College 1992 — 1994
Master's Degree, Human/Medical Genetics, M.S.
McGill University 1989 — 1992
Bachelor's Degree, Molecular Biology
Edwards Lifesciences December 2013 - Present
Heartflow, Inc February 2014 - April 2015
Medtronic November 2010 - February 2015
St. Jude Medical October 2009 - October 2011
Janssen Alzheimer Immunotherapy November 2009 - September 2011
Genzyme May 2010 - March 2011
Schering-Plough Research Institute May 2010 - July 2010
MedImmune September 2006 - November 2009
Schering-Plough Research Institute April 2009 - October 2009
Nexus Oncology October 2008 - January 2009
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Clinical Research, GCP, Clinical Development, Quality Assurance, ICH-GCP, Regulatory Affairs, Clinical Monitoring, FDA, Strategic Planning, Oncology, Regulatory Requirements, EDC, Pharmacovigilance, Protocol
Education
Sarah Lawrence College 1992 — 1994
Master's Degree, Human/Medical Genetics, M.S.
McGill University 1989 — 1992
Bachelor's Degree, Molecular Biology
Sandy Leung, MS's Janssen Alzheimer Immunotherapy Experience June 2012 - June 2013
Job eTMF Manager, eClinical Business Solutions at Onyx Pharmaceuticals
Industry Biotechnology
Experience
Jazz Pharmaceuticals July 2015 - Present
Onyx Pharmaceuticals October 2014 - June 2015
Genentech June 2013 - October 2014
Janssen Alzheimer Immunotherapy June 2012 - June 2013
Janssen Alzheimer Immunotherapy R&D, LLC (Johnson and Johnson Subsidiary) March 2011 - June 2012
Janssen Alzheimer Immunotherapy Research and Development September 2009 - March 2011
Elan Pharmaceuticals March 2009 - September 2009
Elan Pharmaceuticals September 2007 - March 2009
UC Davis April 2005 - June 2007
Skills
Biotechnology, Clinical Trials, GCP, Lifesciences, FDA, Alzheimer's disease, SOP, Project Managment, Trial Master File, GDP, ICH, Microsoft Office, Oracle Clinical, Score, SharePoint, Kofax, Sop, Clinical Development, 21 CFR Part 11, Pharmaceutical Industry, CTMS, ICH-GCP, CRO, Biopharmaceuticals, Clinical Operations, Computer System..., Clinical Data Management, EDC, Regulatory Submissions, Life Sciences
Education
San Jose State University 2009 — 2011
MS, Medical Product Development Management
University of California, Santa Cruz 2008 — 2009
Certificate, Clinical Trials Design and Management
University of California, Davis 2003 — 2007
BS, Biological Sciences, Psychology
Jazz Pharmaceuticals July 2015 - Present
Onyx Pharmaceuticals October 2014 - June 2015
Genentech June 2013 - October 2014
Janssen Alzheimer Immunotherapy June 2012 - June 2013
Janssen Alzheimer Immunotherapy R&D, LLC (Johnson and Johnson Subsidiary) March 2011 - June 2012
Janssen Alzheimer Immunotherapy Research and Development September 2009 - March 2011
Elan Pharmaceuticals March 2009 - September 2009
Elan Pharmaceuticals September 2007 - March 2009
UC Davis April 2005 - June 2007
Skills
Biotechnology, Clinical Trials, GCP, Lifesciences, FDA, Alzheimer's disease, SOP, Project Managment, Trial Master File, GDP, ICH, Microsoft Office, Oracle Clinical, Score, SharePoint, Kofax, Sop, Clinical Development, 21 CFR Part 11, Pharmaceutical Industry, CTMS, ICH-GCP, CRO, Biopharmaceuticals, Clinical Operations, Computer System..., Clinical Data Management, EDC, Regulatory Submissions, Life Sciences
Education
San Jose State University 2009 — 2011
MS, Medical Product Development Management
University of California, Santa Cruz 2008 — 2009
Certificate, Clinical Trials Design and Management
University of California, Davis 2003 — 2007
BS, Biological Sciences, Psychology
Shyam Banuprakash's Janssen Alzheimer Immunotherapy Experience December 2010 - June 2013
Job Director, Clinical Data Management at BioClinica
Industry Information Technology and Services
Experience
BioClinica (formerly Synarc) June 2014 - Present
Synarc June 2013 - June 2014
JANSSEN Alzheimer Immunotherapy December 2010 - June 2013
Janssen Alzheimer Immunotherpay Research and Development April 2010 - December 2010
Medtronic Vascular April 2008 - March 2010
L&T Infotech July 2005 - February 2008
Skills
CDISC, Clinical Data Management, Clinical Trials, Data Management, Clinical Research, Oracle Clinical, Medidata, SAS, CDASH, FDA, Clinical Development, CTMS, Cross-functional Team..., Biostatistics, Lifesciences, 21 CFR Part 11, EDC, CRO, ICH-GCP, Data Analysis, GCP, Protocol, SAS programming, Pharmaceutical Industry, Computer System..., Sop, Oncology, Biotechnology, Databases, Regulatory Submissions, Quality Assurance, Validation, GxP, Life Sciences, SAS Programming, SOP
Education
Anna University
B-Tech, Information Technology
Indian Institute of Commerce and Trade
MBA
BioClinica (formerly Synarc) June 2014 - Present
Synarc June 2013 - June 2014
JANSSEN Alzheimer Immunotherapy December 2010 - June 2013
Janssen Alzheimer Immunotherpay Research and Development April 2010 - December 2010
Medtronic Vascular April 2008 - March 2010
L&T Infotech July 2005 - February 2008
Skills
CDISC, Clinical Data Management, Clinical Trials, Data Management, Clinical Research, Oracle Clinical, Medidata, SAS, CDASH, FDA, Clinical Development, CTMS, Cross-functional Team..., Biostatistics, Lifesciences, 21 CFR Part 11, EDC, CRO, ICH-GCP, Data Analysis, GCP, Protocol, SAS programming, Pharmaceutical Industry, Computer System..., Sop, Oncology, Biotechnology, Databases, Regulatory Submissions, Quality Assurance, Validation, GxP, Life Sciences, SAS Programming, SOP
Education
Anna University
B-Tech, Information Technology
Indian Institute of Commerce and Trade
MBA
Chris Nishioka's Janssen Alzheimer Immunotherapy Experience August 2009 - September 2012
Job Graduate Student at University of California, Riverside
Industry Pharmaceuticals
Experience
University of California, Riverside September 2012 - Present
Janssen Alzheimer Immunotherapy August 2009 - September 2012
Elan Pharmaceuticals June 2008 - September 2012
Seattle Institute for Biomedical and Clinical research June 2007 - June 2008
Skills
Microscopy, Neuroscience, Drug Discovery, Cell Culture, Image Analysis, In Vivo, Assay Development, Immunohistochemistry
Education
University of California, Riverside 2012 — 2017
Doctor of Philosophy (Ph.D.), Neuroscience
University of Washington 2004 — 2008
B.S., Molecular, Cellular and Developmental Biology
University of California, Riverside September 2012 - Present
Janssen Alzheimer Immunotherapy August 2009 - September 2012
Elan Pharmaceuticals June 2008 - September 2012
Seattle Institute for Biomedical and Clinical research June 2007 - June 2008
Skills
Microscopy, Neuroscience, Drug Discovery, Cell Culture, Image Analysis, In Vivo, Assay Development, Immunohistochemistry
Education
University of California, Riverside 2012 — 2017
Doctor of Philosophy (Ph.D.), Neuroscience
University of Washington 2004 — 2008
B.S., Molecular, Cellular and Developmental Biology
Richard Margolin's Janssen Alzheimer Immunotherapy Experience May 2011 - November 2013
Job Vice President, Clinical Development at CereSpir, Inc.
Industry Pharmaceuticals
Experience
CereSpir, Inc. November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2011 - November 2013
Merck Research Laboratories January 2008 - May 2011
i3 Research 2005 - 2008
Keck USC School of Medicine September 2000 - June 2005
Vanderbilt University Medical Center 1997 - 2001
National Institutes of Health 1982 - 1984
Skills
Neuroscience, Biomarkers, Medicine, Drug Development, CRO, Clinical Study Design, Translational Medicine, Psychiatry, Clinical Research, Science, Clinical Development, Treatment, Clinical Trials, Pharmacology, Clinical Pharmacology, Drug Discovery, Neurology, Alzheimer's disease, Pharmaceutical Industry, Translational Research, Medical Research, Lifesciences, Biotechnology, Sop, Immunology, Infectious Diseases, Laboratory, FDA
Education
University of California, Irvine - College of Medicine 1974 — 1977
MD
Harvard University 1968 — 1974
AB, Psychophysiology
CereSpir, Inc. November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2011 - November 2013
Merck Research Laboratories January 2008 - May 2011
i3 Research 2005 - 2008
Keck USC School of Medicine September 2000 - June 2005
Vanderbilt University Medical Center 1997 - 2001
National Institutes of Health 1982 - 1984
Skills
Neuroscience, Biomarkers, Medicine, Drug Development, CRO, Clinical Study Design, Translational Medicine, Psychiatry, Clinical Research, Science, Clinical Development, Treatment, Clinical Trials, Pharmacology, Clinical Pharmacology, Drug Discovery, Neurology, Alzheimer's disease, Pharmaceutical Industry, Translational Research, Medical Research, Lifesciences, Biotechnology, Sop, Immunology, Infectious Diseases, Laboratory, FDA
Education
University of California, Irvine - College of Medicine 1974 — 1977
MD
Harvard University 1968 — 1974
AB, Psychophysiology
Jessica Reaber, CTRS's Janssen Alzheimer Immunotherapy Experience February 2011 - June 2011
Job Program Leader at City of Pleasanton, RADD
Industry Recreational Facilities and Services
Experience
City of Pleasanton October 2011 - Present
JANSSEN Alzheimer Immunotherapy February 2011 - June 2011
Resnick Neuropsy October 2010 - January 2011
Westminster Woods Camp and Conference Center June 2009 - August 2010
Westminster Woods Camp and Conference Center 2004 - 2010
Bidwell Pres September 2008 - May 2009
Orchard Church June 2008 - August 2008
Education
California State University-Chico 2007 — 2010
Bachelor of Science, Recreation Administration: Therapeutic Recreation
City of Pleasanton October 2011 - Present
JANSSEN Alzheimer Immunotherapy February 2011 - June 2011
Resnick Neuropsy October 2010 - January 2011
Westminster Woods Camp and Conference Center June 2009 - August 2010
Westminster Woods Camp and Conference Center 2004 - 2010
Bidwell Pres September 2008 - May 2009
Orchard Church June 2008 - August 2008
Education
California State University-Chico 2007 — 2010
Bachelor of Science, Recreation Administration: Therapeutic Recreation
Monique DeSalvo's Janssen Alzheimer Immunotherapy Experience June 2010 - March 2014
Job
Industry Internet
Experience
Notion June 2015 - Present
Alexza Pharmaceuticals April 2014 - September 2014
Janssen Alzheimer Immunotherapy June 2010 - March 2014
Adams and Reese LLP May 2007 - February 2010
Docusource Litigation Support July 2006 - April 2007
CC's Community Coffee House January 2005 - June 2006
Gulf States Optical Laboratories, Inc. January 2003 - December 2004
Skills
Quality Assurance, 21 CFR Part 11, Document Management, Sop, FDA, Biotechnology, Pharmaceutical Industry, GxP, GCP, Software Documentation, Microsoft Office, Customer Service, Biopharmaceuticals, Change Control, Documentum, SharePoint, Protocol, Photoshop, Troubleshooting, Awesomeness, Access Database, Visio, Inkscape, HTML, Records Management, User Acceptance Testing, CSS, Data Entry, Email, Administrative Functions, EDMS, Adobe Acrobat Pro, Oracle Agile PLM, WordPress, MailChimp
Education
San Francisco State University 2011 — 2011
University of New Orleans 1999 — 2001
General Studies
Notion June 2015 - Present
Alexza Pharmaceuticals April 2014 - September 2014
Janssen Alzheimer Immunotherapy June 2010 - March 2014
Adams and Reese LLP May 2007 - February 2010
Docusource Litigation Support July 2006 - April 2007
CC's Community Coffee House January 2005 - June 2006
Gulf States Optical Laboratories, Inc. January 2003 - December 2004
Skills
Quality Assurance, 21 CFR Part 11, Document Management, Sop, FDA, Biotechnology, Pharmaceutical Industry, GxP, GCP, Software Documentation, Microsoft Office, Customer Service, Biopharmaceuticals, Change Control, Documentum, SharePoint, Protocol, Photoshop, Troubleshooting, Awesomeness, Access Database, Visio, Inkscape, HTML, Records Management, User Acceptance Testing, CSS, Data Entry, Email, Administrative Functions, EDMS, Adobe Acrobat Pro, Oracle Agile PLM, WordPress, MailChimp
Education
San Francisco State University 2011 — 2011
University of New Orleans 1999 — 2001
General Studies
Ed Blank's Janssen Alzheimer Immunotherapy Experience October 2010 - June 2011
Job Biotechnology Professional
Industry Biotechnology
Experience
JANSSEN Alzheimer Immunotherapy October 2010 - June 2011
Bayer HealthCare June 2008 - October 2009
University of California at Berkeley August 2002 - June 2008
Cancer Research Institute of Contra Costa September 1984 - August 2002
Children's Hospital Medical Center, Oakland, CA February 1978 - September 1984
University of California at Davis January 1975 - March 1978
Children's Hospital Medical Center August 1973 - December 1974
Stanford University September 1972 - March 1973
Skills
Antibodies, Cell, SDS-PAGE, Assay Development, ELISA, Protein Chemistry, Cell Culture, Tissue Culture, Western Blotting, Animal Models, In Vivo, RNA isolation, DNA, Purification, RT-PCR, Immunohistochemistry, Laboratory, Clinical Development, HPLC, Monoclonal Antibodies, Cancer, Toxicology, Pharmacokinetics, Clinical Trials
Education
University of California, Davis 1975 — 1978
M.A., Immunology, Virology, Pathology
University of California, Berkeley 1970 — 1972
B. A., Biochemistry
JANSSEN Alzheimer Immunotherapy October 2010 - June 2011
Bayer HealthCare June 2008 - October 2009
University of California at Berkeley August 2002 - June 2008
Cancer Research Institute of Contra Costa September 1984 - August 2002
Children's Hospital Medical Center, Oakland, CA February 1978 - September 1984
University of California at Davis January 1975 - March 1978
Children's Hospital Medical Center August 1973 - December 1974
Stanford University September 1972 - March 1973
Skills
Antibodies, Cell, SDS-PAGE, Assay Development, ELISA, Protein Chemistry, Cell Culture, Tissue Culture, Western Blotting, Animal Models, In Vivo, RNA isolation, DNA, Purification, RT-PCR, Immunohistochemistry, Laboratory, Clinical Development, HPLC, Monoclonal Antibodies, Cancer, Toxicology, Pharmacokinetics, Clinical Trials
Education
University of California, Davis 1975 — 1978
M.A., Immunology, Virology, Pathology
University of California, Berkeley 1970 — 1972
B. A., Biochemistry
Yeong-Liang Lin's Janssen Alzheimer Immunotherapy Experience 2011 - 2013
Job Safety Scientist at Genentech
Industry Pharmaceuticals
Experience
Genentech 2013 - Present
Janssen Alzheimer Immunotherapy 2011 - 2013
Center for Drug Evaluation 2000 - 2010
Sun Yat Sen Cancer Center April 1998 - June 2002
Vanderbilt University Hospital August 1996 - January 1998
National Taiwan University Hospital July 1991 - June 1996
Skills
SAS statistical software, Microsoft Word, Excel,..., Pharmacovigilance, Epidemiologic analysis, Drug Development, Vaccines, Biopharmaceuticals, Sop, FDA, Epidemiology, Analysis, PowerPoint, 21 CFR Part 11, SAS, Drug Safety
Education
Harvard T.H. Chan School of Public Health 2004 — 2005
MS, Epidemiology
National Taiwan University Medical School 1983 — 1990
MD, Medicine
Genentech 2013 - Present
Janssen Alzheimer Immunotherapy 2011 - 2013
Center for Drug Evaluation 2000 - 2010
Sun Yat Sen Cancer Center April 1998 - June 2002
Vanderbilt University Hospital August 1996 - January 1998
National Taiwan University Hospital July 1991 - June 1996
Skills
SAS statistical software, Microsoft Word, Excel,..., Pharmacovigilance, Epidemiologic analysis, Drug Development, Vaccines, Biopharmaceuticals, Sop, FDA, Epidemiology, Analysis, PowerPoint, 21 CFR Part 11, SAS, Drug Safety
Education
Harvard T.H. Chan School of Public Health 2004 — 2005
MS, Epidemiology
National Taiwan University Medical School 1983 — 1990
MD, Medicine
Lupe Adcock's Janssen Alzheimer Immunotherapy Experience March 2011 - October 2013
Job Clinical Business Operations Associate at Medivation
Industry Pharmaceuticals
Experience
Medivation May 2015 - Present
Onyx Pharmaceuticals November 2013 - May 2015
JANSSEN Alzheimer Immunotherapy March 2011 - October 2013
JANSSEN Alzheimer Immunotherapy June 2010 - March 2011
Janssen Alzheimer Immunotherapy April 2010 - June 2010
Skills
Clinical Trials, Clinical Research, CRO, Clinical Operations, GxP, GCP, Biotechnology, Clinical Data Management, Regulatory Submissions, Clinical Development, CTMS, FDA, Livelink, Technical Operations, Ariba, Pharmaceutical Industry, EDC, Supply Chain, SAP
Education
USC
Graduate Certificate in Clinical Research Design and Management
California State Polytechnic University-Pomona
Bachelor of Science (BS), Accounting
Medivation May 2015 - Present
Onyx Pharmaceuticals November 2013 - May 2015
JANSSEN Alzheimer Immunotherapy March 2011 - October 2013
JANSSEN Alzheimer Immunotherapy June 2010 - March 2011
Janssen Alzheimer Immunotherapy April 2010 - June 2010
Skills
Clinical Trials, Clinical Research, CRO, Clinical Operations, GxP, GCP, Biotechnology, Clinical Data Management, Regulatory Submissions, Clinical Development, CTMS, FDA, Livelink, Technical Operations, Ariba, Pharmaceutical Industry, EDC, Supply Chain, SAP
Education
USC
Graduate Certificate in Clinical Research Design and Management
California State Polytechnic University-Pomona
Bachelor of Science (BS), Accounting
Stephanie C. Wong's Janssen Alzheimer Immunotherapy Experience March 2012 - January 2013
Job Research Assistant at Genentech
Industry Research
Experience
Genentech January 2013 - Present
JANSSEN Alzheimer Immunotherapy March 2012 - January 2013
Annual Reviews November 2011 - March 2012
University of Alabama January 2009 - October 2011
University of Alabama January 2009 - May 2009
CALIFORNIA STATE UNIVERSITY January 2007 - December 2008
CALIFORNIA STATE UNIVERSITY August 2006 - June 2008
University of California May 2004 - January 2005
Skills
ELISA
Education
California State University, Fresno
Master of Science, Biology
University of California, San Diego
Bachelor of Science, Biochemistry and Cell Biology
Genentech January 2013 - Present
JANSSEN Alzheimer Immunotherapy March 2012 - January 2013
Annual Reviews November 2011 - March 2012
University of Alabama January 2009 - October 2011
University of Alabama January 2009 - May 2009
CALIFORNIA STATE UNIVERSITY January 2007 - December 2008
CALIFORNIA STATE UNIVERSITY August 2006 - June 2008
University of California May 2004 - January 2005
Skills
ELISA
Education
California State University, Fresno
Master of Science, Biology
University of California, San Diego
Bachelor of Science, Biochemistry and Cell Biology
Trupti Shah's Janssen Alzheimer Immunotherapy Experience December 2011 - September 2013
Job Senior Safety Specialist at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences September 2013 - Present
JANSSEN Alzheimer Immunotherapy December 2011 - September 2013
sanofi-aventis April 2009 - December 2011
Skills
Pharmacovigilance, Lifesciences, Clinical Trials, MedDRA, Sop, Microsoft Office, GCP, FDA, CRO, Clinical Research, Drug Safety, GxP, SOP, Pharmaceutical Industry, Oncology
Education
East Stroudsburg University of Pennsylvania 2003 — 2005
M.S., Biology /Biotech+Immunology
MSU
Gilead Sciences September 2013 - Present
JANSSEN Alzheimer Immunotherapy December 2011 - September 2013
sanofi-aventis April 2009 - December 2011
Skills
Pharmacovigilance, Lifesciences, Clinical Trials, MedDRA, Sop, Microsoft Office, GCP, FDA, CRO, Clinical Research, Drug Safety, GxP, SOP, Pharmaceutical Industry, Oncology
Education
East Stroudsburg University of Pennsylvania 2003 — 2005
M.S., Biology /Biotech+Immunology
MSU
Sejal Vora's Janssen Alzheimer Immunotherapy Experience April 2011 - July 2013
Job Associate Director at Autoimmune and Rare Diseases, Mallinckrodt Pharmaceuticals
Industry Biotechnology
Experience
Questcor Pharmaceuticals, Inc. August 2013 - Present
JANSSEN Alzheimer Immunotherapy April 2011 - July 2013
JANSSEN Alzheimer Immunotherapy September 2009 - April 2011
Elan Pharmaceuticals February 2009 - September 2009
Elan Pharmaceuticals March 2008 - February 2009
Skills
Clinical Development, Medical Affairs, Publications, Medical Communications, Registries
Education
UNC Chapel Hill 1996 — 2002
Doctor of Pharmacy (PharmD), Pharmacy
Questcor Pharmaceuticals, Inc. August 2013 - Present
JANSSEN Alzheimer Immunotherapy April 2011 - July 2013
JANSSEN Alzheimer Immunotherapy September 2009 - April 2011
Elan Pharmaceuticals February 2009 - September 2009
Elan Pharmaceuticals March 2008 - February 2009
Skills
Clinical Development, Medical Affairs, Publications, Medical Communications, Registries
Education
UNC Chapel Hill 1996 — 2002
Doctor of Pharmacy (PharmD), Pharmacy
Yi-Zheng Xu's Janssen Alzheimer Immunotherapy Experience 2010 - Present
Job Biotechnology Professional
Industry Biotechnology
Experience
JANSSEN Alzheimer Immunotherapy 2010 - Present
Elan Pharmaceuticals August 2004 - October 2010
Roche August 1994 - April 2004
Skills
Bioanalytical assay...
Education
Baylor College of Medicine 1982 — 1988
Doctor of Philosophy (Ph.D.), Biochemistry
Fudan University 1978 — 1982
Bachelor's degree, Biochemistry
JANSSEN Alzheimer Immunotherapy 2010 - Present
Elan Pharmaceuticals August 2004 - October 2010
Roche August 1994 - April 2004
Skills
Bioanalytical assay...
Education
Baylor College of Medicine 1982 — 1988
Doctor of Philosophy (Ph.D.), Biochemistry
Fudan University 1978 — 1982
Bachelor's degree, Biochemistry