Kyowa Hakko Kirin Pharma, Inc.
Industry: Pharmaceutical company
DescriptionFounded: 1992 Parent organization: Kyowa Hakko Kirin Co., Ltd.
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Kyowa Hakko Kirin Pharma, Inc. Employees
ERAD Therapeutics, Inc. December 2014 - Present
PARS Pharmaceutical Consulting April 2013 - 2014
G Spitalny Biopharma Consulting January 2012 - 2014
Kyowa Hakko Kirin Pharma, Inc. July 2010 - February 2012
Kyowa Kakko Kirin Pharma, Inc. January 2009 - July 2010
BioWa, Inc. (subsidiary of Kyowa Hakko) January 2005 - December 2008
Elusys Therapeutics, Inc. March 2001 - January 2005
Select Therapeutics, Inc. January 1997 - March 2001
Zotic Ltd. January 1995 - December 1997
TargeTech, Inc. January 1990 - December 1995
Skills
Biotechnology, Clinical Trials, Oncology, Clinical Development, Infectious Diseases, Immunology, Clinical Research, Strategic Planning, Drug Discovery, R&D, Cross-functional Team..., Business Strategy, IND, Parasitology, Malaria, Biodefense, Animal Models, Gene Therapy, Monoclonal Antibodies, Metabolic Diseases, Antibodies, Clinical Trial..., Protocol Development, Allergy, Medical Writing, Technical Presentations, Investor Presentations, Lifesciences, GLP, Regulatory Affairs, FDA, Technology Transfer, Drug Development, CTMS, Life Sciences, Metabolism, Protocol
Education
New York University School of Medicine
Ph.D., Parasitology/Immunology
The Pennsylvania State University
B.S., Biology
Kyowa Hakko Kirin Pharma, Inc. April 2013 - Present
Kyowa Hakko Kirin Pharma, Inc. April 2012 - March 2013
Bristol-Myers Squibb January 2011 - April 2012
Bristol-Myers Squibb April 2008 - December 2010
Bayer Pharmaceuticals 2005 - 2008
Pfizer Pharmaceuticals 2003 - 2005
Durus Capital Management 2002 - 2003
Bristol-Myers Squibb 1997 - 2002
National Institutes of HealthB 1993 - 1997
National Institutes of Health 1990 - 1993
Education
Case Western Reserve University School of Medicine 1983 — 1987
M.D.
Harvard University 1979 — 1983
A.B., Mathematics
Kyowa Hakko Kirin Pharma, Inc. October 2013 - Present
Kyowa Hakko Kirin Korea Co., Ltd. October 2010 - September 2013
Kyowa Hakko Kirin Co., Ltd. April 2005 - September 2010
Skills
Clinical Development, Oncology, Pharmaceutics, Clinical Research, Translational Research, Pharmaceutical Industry, Clinical Trials, Biotechnology, Regulatory Affairs, SOP
Education
北里大学 / Kitasato University 2001 — 2005
Pharmaceutical, Pharmacy
Kyowa Hakko Kirin Pharma, Inc. 2001 - Present
Enhance Pharmaceuticals 1995 - 2001
Novo Nordisk 1993 - 1995
Enzon Pharmaceuticals 1991 - 1993
Skills
Biotechnology, Pharmaceutical Industry, Organizational..., Quality Assurance, Entrepreneurship, Pharmacovigilance
Education
Fielding Graduate University 2006 — 2014
Doctor of Philosophy (Ph.D.), Human and Organizational Development
Temple University 1993 — 1996
Master's Degree, Pharmaceutical Quality Assurance and Regulatory Affairs
Rutgers University-New Brunswick 1982 — 1989
Bachelor's Degree, Biology/Microbiology
National Institute of Clinical Research 2011 - Present
Kyowa Hakko Kirin Pharma, Inc. 2005 - 2010
Global Care Surgery Center, LLC 2003 - 2006
Clinical Medicine 1992 - 2005
VNA Hospice 2000 - 2003
Skills
Biotechnology, Clinical Development, Clinical, Clinical Trials, Clinical Research
Education
University of California, Irvine 2002 — 2004
MBA, Healthcare Management
Drexel University College of Medicine 1986 — 1990
MD, Medicine
Wharton School, University of Pennsylvania 1981 — 1985
BS Economics
Momenta Pharmaceuticals 2012 - Present
Progenics Pharmaceuticals 2011 - 2011
Kyowa Hakko Kirin Pharma, Inc. 2009 - 2010
Kyowa Hakko Kirin Pharma, Inc. 2006 - 2008
Amcyte, Inc August 2001 - September 2006
Baxter Hyland Division 1990 - 1997
Skills
Regulatory Affairs, Cell Therapy, cGLP, Clinical Development, CMC, Medical Devices, Quality System, GCP, Product Development, Biologics, Pharmaceutical Industry, Biotechnology
Education
University of Illinois College of Medicine
Ph.D., Pathology/Experimental Biology/Immunology
Kyowa Hakko Kirin Pharma, Inc. March 2013 - Present
Celgene February 2011 - March 2013
Project Management Consulting October 2008 - February 2011
Bristol-Myers Squibb April 2006 - October 2008
Barrier Therapeutics 2004 - 2006
Daiichi Sankyo October 2002 - April 2004
Amgen June 1996 - October 2002
Skills
Cross-functional Team..., Program Management, Strategy, Clinical Development, Pharmaceutical Industry, Oncology, Clinical Trials, Biotechnology, Drug Development, Lifesciences, Regulatory Submissions, Project Management, Neurology, Dermatology, IND, Project Portfolio..., Strategic Planning, Diabetes, Change Management, Leadership, PMP, Clinical Research, GCP, CTMS, Life Sciences
Education
University of California, Los Angeles - The Anderson School of Management 1999 — 2003
MBA, General Management
Brown University 1994 — 1996
MS, Behavioral Neuroscience
San Jose State University 1990 — 1994
BA, Psychology, Sociology
Bracco Diagnostics January 2011 - Present
Kyowa Hakko Kirin Pharma, Inc. August 2009 - January 2011
Bristol-Myers Squibb 2005 - 2008
GE Healthcare 2002 - 2005
Bristol-Myers Squibb 1999 - 2002
Bristol-Myers Squibb 1997 - 1999
Skills
Regulatory Affairs, FDA, GMP, Regulatory Submissions, CMC, Project Management, Manufacturing, GLP, Sop, 21 CFR Part 11, Change Control, IND, Pharmaceutical Industry, GCP, Validation
Education
Faculdades Oswaldo Cruz 1980 — 1985
MS, Chemical Engineering
Kyowa Hakko Kirin Pharma, Inc. September 2011 - Present
Premier Research Group May 2009 - September 2011
Covance September 2006 - May 2009
Wyeth January 2006 - September 2006
Wyeth June 2002 - June 2005
Wyeth Global Safety Surveillance & Epidemiology June 1998 - June 2002
AstraMerck 1994 - 1998
Skills
Pharmacovigilance, Clinical Trials, SOP, FDA, Compliance, Signal detection, Sop, Pharmaceutics, Drug Safety, Protocol, Pharmaceutical Industry, Regulatory Requirements, Infectious Diseases, Process Improvement, Pharmacy, Regulatory Submissions, CRO, Diabetes, Clinical Development, Regulatory Affairs, GCP, CTMS, Training, Oncology, Clinical Research, Medical Writing, EDC, Medical Affairs, IND, 21 CFR Part 11, Therapeutic Areas, Clinical Data Management, Biotechnology, Biopharmaceuticals
Education
University of the Sciences in Philadelphia 1995 — 2000
Pharm.D., Pharmacy
University of the Sciences in Philadelphia 1985 — 1988
B.S. Pharmacy, Pharmacy
University of Pennsylvania 1979 — 1983
B.A., Biology
Kyowa Hakko Kirin Pharma, Inc. July 2014 - Present
EMD Serono, Inc. April 2013 - June 2014
EMD Serono, Inc. May 2012 - March 2013
EMD Serono, Inc. March 2012 - March 2013
Bristol-Myers Squibb June 2005 - March 2012
Amersham Health 2000 - 2005
Pharmacia 1993 - 2000
SmithKline Beecham 1990 - 1993
The Ohio State University Medical Center 1988 - 1990
Skills
Regulatory Affairs, Oncology, Biotechnology, Strategy, Lifesciences, Clinical Development, Clinical Trials, Regulatory Submissions, Cardiology, Pharmaceutical Industry, Product Launch, Biopharmaceuticals, Validation, R&D, GCP, CTMS, Drug Discovery, Pharmacovigilance, Medicine, Medical Affairs, Drug Development, Diabetes, Medical Devices, Cross-functional Team..., Clinical Research, FDA, Healthcare, CRO, Technology Transfer, Infectious Diseases, Pharmaceutics, Immunology, Biologics, Therapeutic Areas, IND, Medical Writing, Vaccines, 21 CFR Part 11, CMC, GMP, GLP, Commercialization, Pharmacology, CAPA, Sop, Regulatory Requirements, Neurology, eCTD, Toxicology, NDA
Education
University of Notre Dame 1983 — 1988
Ph.D., Microbiology
University of Notre Dame 1978 — 1982
B.S, Biology
Asana BioSciences, LLC September 2015 - Present
Daiichi Sankyo, Inc. February 2015 - Present
Kyowa Hakko Kirin Pharma, Inc. January 2014 - January 2015
Kyowa Hakko Kirin Pharma, Inc. January 2011 - January 2015
Kyowa Hakko Kirin Pharma, Inc. June 2012 - December 2013
Kyowa Hakko Kirin Pharma, Inc. September 2010 - June 2012
Huntingdon Life Sciences January 2009 - September 2010
Elusys Therapeutics, Inc. June 2006 - August 2008
UCHC 2003 - 2006
Skills
Strategic Planning, Financial Analysis, Corporate Finance, Business Valuation, Equity Valuation, Cross-functional Team..., Program Management, Biotechnology, Pharmaceuticals, Drug Development, Clinical Research, Clinical Trials, Drug Discovery, R&D, Oncology, Autoimmune Diseases, Infectious Diseases, Immunology, Excel, MS Project, Word, Data Analysis, PowerPoint, Root Cause Analysis, Cell Based Assays, Enzyme Assays, Microsoft Excel, Pharmaceutical Industry, Cell, Global Management, IND, Biomarkers, FDA, Vaccines, GLP, Regulatory Submissions, CRO, Monoclonal Antibodies, Biopharmaceuticals, Lifesciences, Immunoassays, Animal Models, Regulatory Affairs, Life Sciences
Education
New York University - Leonard N. Stern School of Business 2009 — 2012
MBA, Corporate Finance, Strategy
Monash University 1993 — 2003
Bachelor of Science (BS), PhD, Immunology
Janssen R&D March 2015 - Present
Kyowa Hakko Kirin Pharma, Inc. June 2011 - December 2014
Bayer HealthCare January 2008 - April 2011
Omnicare Clinical Research June 2004 - January 2008
Skills
Clinical Research, Project Planning, Clinical Trial..., Partnership Management, Project Delivery, Clinical Trials, Clinical Development, Timeline Development, Project Coordination, Leadership, Cross-functional Team..., Pharmaceutical Industry, Vendor Management, CRO, Protocol, EDC, CTMS, GCP, Clinical Operations, Clinical, Clinical Monitoring, ICH-GCP, Clinical Study Design, Cardiology, Endocrinology, Site Management, Quality Assurance, Immunology, Software Documentation, Coaching, Location Intelligence, Partner Management, Site Selection, Research, Mentoring, Documentation, Database Integrity, Forecasting, Collaborative Problem..., KOL Identification, Leadership Development, Medical Liaison, Liaison, Phase I, Phase II, Phase III, Post Market Surveillance, Oncology, Construction
Education
Marian College 1982 — 1984
BS, Biology and Chemistry
Loretto Heights College 1978 — 1982
BSN, Nursing
Kyowa Hakko Kirin Pharma, Inc. July 2012 - Present
URL Pharma, Inc. / Mutual Pharmaceutical Company July 2009 - July 2012
GE Healthcare / Medical Diagnostics March 2006 - July 2009
PharmaNet September 1999 - October 2005
Theradex June 1998 - September 1999
Thomas Jefferson University April 1996 - June 1998
Fox Chase Cancer Center September 1987 - April 1996
Fox Chase Cancer Center 1986 - 1992
University of Pennsylvania Health System 1979 - 1986
Skills
Medical Writing, Clinical Development, Medical Diagnostics, Clinical Trials, Oncology, GCP, Regulatory Submissions, Medical Communications, Clinical Data Management, Drug Development, ICH-GCP, CRO, Protocol, FDA, Clinical Research, Sop, Medical Affairs, Regulatory Requirements, Pharmaceutical Industry, Medical Devices, Pharmacovigilance, CTMS, Software Documentation, Rheumatology, Infectious Diseases, Hematology, Data Management, Regulatory Affairs, Therapeutic Areas, Clinical Study Design, Biostatistics, Clinical Operations, EDC, IND, SOP
Education
University of Pennsylvania 1983 — 1986
MSN, Nursing
Asana BioSciences, LLC June 2014 - Present
Endo January 2012 - May 2014
Kyowa Hakko Kirin Pharma, Inc. September 2005 - January 2012
Forest Laboratories, Inc September 2001 - September 2005
Aventis Pharmaceuticals December 1998 - September 2001
Hoechst Marion Roussel 1989 - 1998
University of Montana October 1987 - December 1989
Skills
Clinical Development, DMPK, Pharmacokinetics, Clinical Pharmacology, Biomarkers, Drug Metabolism, CRO, Drug Development, Regulatory Submissions, IND, Drug Discovery, Clinical Research, Pharmacodynamics, HPLC, Clinical Trials, Oncology, Pharmacology
Education
University of Houston 1982 — 1987
Doctor of Philosophy (PhD), Pharmacokinetics
Dr. H S Gour Central University
BS, Pharmaceutical Sciences, Pharmaceutical Sciences
The University of Georgia
Novartis Pharmaceuticals Corporation February 2012 - Present
Amicus Therapeutics June 2011 - December 2011
Theradex Systems, Inc. 2011 - 2011
Kyowa Hakko Kirin Pharma, Inc. October 2004 - December 2010
Medarex, Inc. 2002 - 2004
Wyeth 1999 - 2001
Skills
Clinical Trials, Clinical Development, CRO, CTMS, GCP, Pharmaceutical Industry, Drug Development, Oncology, Clinical Research, Clinical Monitoring, EDC
Education
University of Manitoba 1984 — 1988
PhD, Immunology
University of Manchester, Faculty of Medicine 1982 — 1984
M.Sc., Immunology
Kyowa Hakko Kirin Pharma, Inc. Manager, Clinical OncologyKyowa Hakko Kirin Co., Ltd.December 2010 - March 2013
Kyowa Hakko Kirin Co., Ltd. June 2009 - April 2011
BioWa, Inc. July 2004 - May 2009
Skills
Clinical Development, Pharmaceutical Industry, Business Development, Lifesciences, Drug Discovery, Clinical Trials, Oncology, Biotechnology, Drug Development, CRO, Immunology, Biopharmaceuticals, Technology Transfer
Education
The University of Tokyo 1989 — 1999
Ph.D.
Kyowa Hakko Kirin Pharma, Inc. November 2013 - Present
Source Consulting, LLC 1998 - Present
Source Consulting, LLC 1998 - Present
Kyowa Hakko Kirin Pharma, Inc. March 2013 - November 2013
Cmed Clinical Services February 2012 - March 2013
Enzon Pharmaceuticals March 2010 - January 2012
BD Diagnostics, TriPath Imaging May 2007 - May 2009
Clinsys Clinical Research 2001 - 2007
Skills
Research, Teaching, Economics, Microsoft Office, Strategic Planning, Team Leadership, Mentoring, Clinical Trials, Clinical Monitoring, Oncology, Infectious Diseases, EDC, GCP, Clinical Data Management, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Quality Assurance, CRO, Clinical Research
Education
University of Delaware 1976 — 1980
B.A.A.S, Economics, 3.9/4.0
Burlington County College 1991 — 1995
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse, 3.8/4.0
Kyowa Hakko Kirin Pharma, Inc. April 2015 - Present
ikaria June 2011 - April 2015
Amicus Therapeutics September 2009 - June 2011
PTC Therapeutics February 2008 - September 2009
GPC Biotech November 2004 - February 2008
Bristol-Myers Squibb August 1991 - August 2004
American Cyanamid September 1986 - August 1991
BioResearch Laboratories September 1981 - September 1986
University of Rhode Island 1976 - 1981
Skills
Clinical Pharmacology, DMPK, Clinical Research, Clinical Trials, Clinical, Pharmacokinetics, Drug Metabolism, Leading Projects, Drug Discovery, ADME, Pharmaceuticals, Pharmacodynamics, IND, Due Diligence, GLP, Clinical Development, Pharmacology, Pharmaceutical Industry, GCP, CRO, Biotechnology, Drug Development, Biomarkers, Oncology, Toxicology, Translational Medicine, Biopharmaceuticals, In Vivo, Therapeutic Areas, CTMS, Infectious Diseases, Medical Writing, Bioanalysis, Lifesciences, Pharmacovigilance, Regulatory Submissions, Life Sciences, Regulatory Affairs, FDA
Education
The University of Connecticut 1972 — 1976
PhD, Pharmacokinetics
Rensselaer Polytechnic Institute 1968 — 1972
BS, Biology
Onyx Pharmaceuticals February 2013 - Present
Kyowa Hakko Kirin Pharma, Inc. September 2007 - January 2013
Elusys Therapeutics September 2000 - September 2007
Skills
CRO, Drug Development, Oncology, Clinical Development, Pharmaceutical Industry, CTMS, Lifesciences, Cell, Regulatory Submissions, Regulatory Affairs, IND, Biopharmaceuticals, Biotechnology, Clinical Research, Clinical Trials, Molecular Biology, GCP, Drug Discovery
Education
University of Maryland Baltimore County 1994 — 2000
PhD, Biochemical Engineering
Indian Institute of Technology, Roorkee 1989 — 1993
BE, Chemical Engineering
Kyowa Hakko Kirin Pharma, Inc. April 2013 - Present
URL Pharma, Inc. May 2010 - March 2013
URL Pharma January 2009 - May 2010
Ortho-McNeil Janssen Scientific Affairs February 2008 - January 2009
Johnson & Johnson, Benefit Risk Management November 2004 - January 2008
Ortho-McNeil Pharmaceutical 2002 - 2004
Washington University School of Medicine January 1986 - September 1987
Rutgers, The State University of New Jersey 1980 - 1985
Skills
Clinical Trials, Pharmacovigilance, Medicine, GCP, Research, Leadership, Medical Writing, Medical Education, Oncology, Medical Affairs, Diabetes, Clinical Development, Gastroenterology, Pharmaceutical Industry, Clinical Research, Neurology, Immunology, Rheumatology, Advisory Boards, Infectious Diseases, Lifesciences, Strategic Thinking, Entrepreneurship, Small Business, Franchising, Drug Safety, Leadership Development, Team Leadership, Drug Development, Therapeutic Areas, FDA, Regulatory Affairs, Regulatory Submissions, CRO, Cardiology, Endocrinology, Pharmacology, Vaccines, Nephrology, Dermatology, CTMS, Pharmaceutics, Medical Communications, Clinical Pharmacology, Biopharmaceuticals
Education
Drexel University 2001 — 2003
MBA, Pharmaceutical Management
Washington University School of Medicine in St. Louis 1985 — 1986
Post-Doctoral Fellow, Metabolism & Endocrinology
Rutgers University-New Brunswick 1980 — 1985
Ph.D., Nutritional Biochemistry
Rutgers University-New Brunswick 1978 — 1980
M.S., Zoology
Rutgers, The State University of New Jersey-New Brunswick 1973 — 1977
Paterson Catholic HS
Independent May 2013 - Present
Kyowa Hakko Kirin Pharma, Inc. August 2010 - April 2013
Kyowa Hakko Kirin Pharma Inc. January 2008 - August 2010
GE Healthcare 2001 - 2004
Amersham Health 1999 - 2004
Nuclear Imaging Systems 1998 - 1999
Skills
Quality Assurance, GCP, 21 CFR Part 11, FDA, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Validation, EDC, Quality System, Protocol, ICH-GCP, Clinical Research
Education
Thomas Edison State College 1982 — 1992
Bachelor of Science (BS), Nuclear Medicine
Kyowa Hakko Kirin Pharma, Inc. September 2013 - Present
J&J PRD March 2009 - September 2013
Johnson & Johnson PRD March 2005 - March 2009
Johnson & Johnson PRD September 2001 - March 2005
Johnson & Johnson PRD March 1999 - September 2001
Roche 1997 - 1999
Jeffrey Hartford, MD 1987 - 1997
Skills
GCP, Sop, Clinical Development, Clinical Trials, Quality Assurance, FDA, 21 CFR Part 11, CAPA, Pharmaceutical Industry, Computer System..., Regulatory Affairs, CRO, GMP, GLP, CTMS, Biopharmaceuticals, Biotechnology, GxP, Software Documentation, Drug Development, SOP
Education
Centenary College
Bachelor's degree
Mercer County Community College
Associate's Degree
Temple University
QA/RA
State of NJ, Department of Health
Emergency Medical Technician
Montgomery High School
HS
Kyowa Hakko Kirin Pharma, Inc. January 2013 - Present
Kyowa Hakko Kirin Pharma, Inc November 2004 - December 2012
Endo Pharmaceuticals June 2001 - October 2004
Janssen Pharmaceutica January 1999 - April 2001
Janssen Pharmaceutica January 1998 - January 1999
Skills
CTD, Regulatory Submissions, Pharmaceutical Industry, IND, Clinical Trials, Drug Development, Validation, Regulatory Requirements, Lifesciences, Regulatory Affairs
Education
Central State University 1993 — 1997
BS, Water Resources Management
CORE Clinical Solutions, LLC August 2014 - Present
Kyowa Hakko Kirin Pharma, Inc. June 2009 - August 2014
Merck & Co., Inc January 2003 - June 2009
Clinical Research Group, Inc. October 1996 - July 2002
Abington Memorial Hospital April 1990 - October 1996
Skills
Clinical Development, Clinical Research, Clinical Trials, CTMS, Oncology, Drug Development, CRO, EDC, Microsoft Office, GCP, Data Analysis, Database Design, Clinical Monitoring, Pharmacovigilance, FDA, Drug Discovery, Biotechnology, Clinical Data Management, Immunology, Clinical Operations, Phase I, Therapeutic Areas, IND, Protocol, Neurology, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, Medical Writing, ICH-GCP, CRO Management, SOP Development
Education
Drexel University 2006 — 2008
Masters of Science, Clinical Research Operations and Management
Penn State University 1991 — 1996
B.A., General Arts and Sciences
Kyowa Hakko Kirin Pharma, Inc. October 2014 - Present
Kite Pharma November 2012 - September 2014
Pfizer December 2004 - October 2012
CancerVax Corporation, CA 2002 - 2004
Cell Genesys 1999 - 2002
Pasteur Merieux Connaught 1997 - 1999
Skills
Clinical Development, Oncology, Clinical Trials, Immunology, Clinical Research, Cancer, Vaccines
Education
Caltech
Bachelor of Science (BS)
National cancer institute
University of California, San Diego
Doctor of Medicine (MD)
University of Washington
Pediatrics Residency Program
Weinberger Law Group, LLC January 2015 - Present
Garden State Council, Boy Scouts of America January 2011 - Present
Office Team September 2014 - January 2015
Kyowa Hakko Kirin Pharma, Inc. October 2012 - August 2013
The Logistics Company January 2009 - December 2010
J & J, PGSM 2004 - November 2009
Johnson & Johnson 2000 - 2008
Johnson & Johnson, Pharmaceuticals Group Strategic Marketing - Global Asset Valuation & Finance January 2000 - September 2004
The GluckShaw Group January 1999 - January 2000
Global Terminal & Container Services January 1998 - June 1999
Skills
Microsoft Office, Outlook, Spreadsheets, Microsoft Word, Microsoft Excel, Pharmaceutical Industry, Administrative..., Access, PowerPoint, Software Documentation, Office Management, Inventory Management, Customer Service, Travel Arrangements, Calendars, Quality Assurance, SOP development, Training Documentation, Management, Training, Program Management, Recruiting, Leadership, Process Scheduler
Education
Bordentown Regional High School 1969 — 1973
Diploma, Business
Burlington County College
Kyowa Hakko Kirin Pharma, Inc. July 2009 - Present
Mercy County Community College 2001 - 2011
JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT Bridgewater, NJ July 2008 - June 2009
Savient Pharmaceuticals, Inc. 1995 - 2004
The Liposome Company 1993 - 1995
In Vivo 1991 - 1993
Ortho Diagnostic Inc 1985 - 1990
Skills
Clinical Trials, Oncology, Pharmacovigilance, Clinical Research, Protocol, Clinical Operations, Biostatistics, CTMS, GCP, Clinical Development, Regulatory Affairs, CRO, CRF design, EDC, Clinical Monitoring, Drug Development, Regulatory Submissions, Cardiology, ICH-GCP, Data Management, Infectious Diseases, GLP, Clinical Data Management
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science (BS), Medical Technology/Technologist
Kyowa Hakko Kirin Pharma, Inc. March 2014 - Present
IKARIA, Inc. September 2013 - March 2014
IKARIA, Inc. September 2012 - August 2013
IKARIA, Inc. October 2011 - August 2012
Sanofi-Aventis September 2007 - January 2012
Bristol-Myers Squibb February 2007 - September 2007
Skills
Pharmacovigilance, Clinical Development, SOP, FDA, Medical Devices, R&D, Psychiatry, Drug Safety, Pharmaceutical Industry, Clinical Trials, Drug Development, IND, Therapeutic Areas, Oncology, Sop
Education
University of Pennsylvania School of Medicine 2000 — 2005
MD, medicine
University of Pennsylvania 1995 — 1999
BS
Kyowa Hakko Kirin Pharma, Inc. April 2011 - Present
A Regulatory/Pharmaceutical Writing Company November 2008 - March 2011
Bristol-Myers Squibb December 2002 - November 2008
Bristol-Myers Squibb October 2001 - December 2002
DuPont Pharmaceuticals January 2001 - October 2001
DuPont Pharmaceuticals June 1989 - December 2000
Skills
eCTD, Regulatory Affairs, Regulatory Submissions, Clinical Development, IND, Clinical Trials, CMC, Oncology, GMP, Validation, Pharmaceutical Industry, Drug Development, Sop, Drug Discovery, Biopharmaceuticals
Education
Penn State University
BS, Microbiology
Villanova University
MS, Biology
Novartis August 2015 - Present
Kyowa Hakko Kirin Pharma, Inc. March 2014 - May 2015
Merck February 2008 - November 2013
Aptuit April 2006 - February 2008
Aptuit August 2005 - April 2006
Skills
Management, Project Management, Pharmaceutical Industry, GMP, CRO, Sop, GCP, Clinical Trials, Cross-functional Team..., Supply Chain Management, Validation, FDA, Shipping, CAPA, Regulatory Affairs, 21 CFR Part 11, Quality Assurance, Protocol, Quality System, Biotechnology, CTMS, Demand Planning, Quality Control, GxP, Computer System..., Change Control, Clinical Development, Clinical Supplies, Biopharmaceuticals, GLP, Technology Transfer, Pharmaceutics, SOP
Education
Seton Hall University 1999 — 2004
Bachelor's degree and Masters of Arts, International Relations and Diplomacy, Five Year Program
Novartis Vaccines and Diagnostics August 2013 - Present
Sanofi September 2011 - July 2013
Kyowa Hakko Kirin Pharma, Inc. January 2011 - June 2011
Johnson & Johnson April 2010 - December 2010
Pharmanet Development Group, Inc. February 2002 - October 2009
Advanced Biomedical Research, Inc. (ABR) 2000 - 2002
Advanced Biologics, Inc. 1999 - 2000
GlaxoSmithKline 1997 - 1999
Merck 1996 - 1997
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, Protocol, Endocrinology, Quality Assurance, CTMS, Clinical Study Design, GCP, CRO, Clinical Development, Oncology, EDC, Clinical Monitoring, ICH-GCP, Vaccines
Education
Gwynedd Mercy University 1992 — 1994
Registered Nurse (RN), Nursing
Temple University 1990 — 1992
Graduate School/Criminal Justice
University of New Hampshire 1983 — 1987
BA, Political Science, History, Women's Studies
Pfizer July 2014 - Present
Pfizer November 2013 - Present
Cancer Immunotherapy Consortium 2008 - Present
Kyowa Hakko Kirin Pharma, Inc. November 2012 - September 2013
Bristol-Myers Squibb October 2009 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey 2007 - November 2012
BMS 2007 - March 2011
PharmaNet Development Group, Inc. May 2006 - December 2007
Skills
Creative Writing, Public Speaking, Sculpture, Pharmacovigilance, Oncology, Clinical Development, Clinical Research, Cancer, Protocol Development, Clinical, Clinical Trials, Drug Development, Medical Affairs, Clinical Study Design, Translational Medicine, Pharmaceutical Industry, Regulatory Submissions, Biomarkers, Clinical Monitoring, Medical Education, Biologics, Epidemiology, Hematology, Immunology, Medical Writing, CRO, Infectious Diseases, CTMS, Protocol, Medicine, GCP, Biotechnology, Therapeutic Areas, Cardiology, Biopharmaceuticals, Pharmaceutics, Oncology Clinical..., Pharmacology, IND, ICH-GCP, Endocrinology, Vaccines, Dermatology, Rheumatology, Regulatory Affairs, Neuroscience
Education
Philadelphia College of Osteopathic Medicine 1990 — 1994
DO, Doctor of Osteopathy
Temple University 1985 — 1988
BA, Biology
Muhlenberg College
Kyowa Hakko Kirin Pharma, Inc. May 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2010 - July 2014
Daiichi Sankyo, Inc. October 2007 - July 2010
PRA Health Sciences September 2000 - June 2004
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, Research, PowerPoint, Sales, Leadership, Training, Photoshop, Employee Training
Education
Brookdale Community College 1995 — 2000
Associate of Science (A.S.), Math/Science
Kyowa Hakko Kirin Pharma, Inc. September 2012 - December 2013
Johnson & Johnson December 2010 - September 2012
PharmaNet Development Group, Inc. May 2001 - February 2004
PharmaNet Development Group, Inc. 1999 - 2001
PharmaNet Development Group, Inc. 1998 - 1999
Covance 1992 - 1998
Covance 1990 - 1992
R. W. Johnson Pharmaceutical Research Institute 1988 - 1990
Skills
CDISC, Clinical Trials, Biostatistics, Clinical Development, CRO, SAS programming, EDC, Clinical Study Design, GCP, Clinical Data Management, Statistical Programming, Clinical Research, SAS, Oncology, Regulatory Submissions, Pharmaceutical Industry, SAS Programming
Education
Kansas State University 1986 — 1988
MS, Statistics
Kansas State University 1982 — 1986
BS, Statistics
Kyowa Hakko Kirin Pharma, Inc. May 2013 - Present
Pfizer February 2013 - May 2013
Merck & Co January 2011 - December 2011
Schering Plough January 2009 - December 2010
Schering Plough January 2000 - December 2008
Stop & Shop January 1996 - January 2000
Skills
Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, Therapeutic Areas, MedDRA, Regulatory Requirements, Drug Safety, Validation, Clinical Research, Clinical Data Management, IND, Infectious Diseases, FDA, CTMS, Sop, 21 CFR Part 11, ICH-GCP, Drug Development, Clinical Monitoring, Pharmaceutics, Pharmacists, EDC, CRO
Education
University of Kansas
PharmD, Pharmacy
Long Island University, Brooklyn Campus
BS, Pharmacy
Rutgers, The State University of New Jersey-New Brunswick
BS
Kyowa Hakko Kirin Pharma, Inc. 2006 - Present
Kyowa Hakko Kirin California 2006 - Present
Skills
Immunology, Multi-color Flow..., ELISA, qRT-PCR, Mammalian Cell Culture, Bacterial Cell Culture, siRNA, Lentivirus, Animal Models, Antisense Technologies, Gene Silencing, Immunohistochemistry, Western Blotting, Southern Blot, Antibodies, Luminex, Quantigene
Education
University of California, Berkeley
Genetics and Plant Biology