Mitsubishi Tanabe Pharma Development America
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Mitsubishi Tanabe Pharma Development America Employees
Weill Cornell Medical College July 2013 - Present
Mitsubishi Tanabe Pharma Development America July 2013 - Present
Mitsubishi Tanabe Pharma Development America, Inc. November 2012 - 2013
Hoffmann-La Roche November 2011 - November 2012
Hoffmann-La Roche August 2010 - November 2011
Hoffmann-La Roche 2007 - 2010
Revotar Biopharmaceuticals AG 2005 - 2007
Revotar Biopharmaceuticals AG 2002 - 2005
Theragen AG 1999 - 2002
Humboldt-University of Berlin & MDC Berlin 1996 - 1999
Skills
Translational Medicine, Immunology, Internal Medicine, Clinical Development, Biomarkers, Pharmaceutical Industry, Drug Development, Oncology, Biotechnology, Biopharmaceuticals, Clinical Trials, Clinical Research, Inflammation, R&D, Pharmacology, Drug Discovery, GCP, Asthma, IND, CRO, Lifesciences, Medical Affairs, Pharmaceutics, Virology, Infectious Diseases, Therapeutic Areas, Pharmacokinetics, Biomarker Discovery, Vaccines, GLP, Regulatory Submissions, Small Molecules, Pharmacovigilance, CTMS, In Vitro, Biologics, Medical Research, In Vivo, Genetics, DNA, Translational Research
Education
Rutgers, The State University of New Jersey-Newark 2009 — 2010
Mini-MBA, Biopharmaceutical Innovation
Humboldt-Universität zu Berlin 1996 — 2000
Board certification Internal Medicine, Internal Medicine
Weill Medical College of Cornell University 1994 — 1996
Postdoctoral Training
Leipzig University 1983 — 1990
M.D., Ph.D., Medicine, Immunobiology
Chembio Diagnostic Systems, Inc. August 2013 - Present
Consulting Private, 1- 10 employees January 2011 - Present
Mitsubishi Tanabe Pharma Development America May 2013 - August 2013
BD Diagnostics December 2012 - April 2013
Chembio Diagnostic Systems, Inc. November 2006 - November 2012
Skills
Immunohistochemistry, Confocal Microscopy, Fluorescence Microscopy, General Surgery, Laboratory Research, Statistics, Life Sciences, University Teaching, Medical Writing, Medical Devices, Science Education, Contract Negotiation, Contract Management, Legal Writing, Regulatory Affairs, Regulatory Reporting, Regulatory Requirements, Regulatory Submissions, Regulatory Liaison, Regulatory Strategy, Regulatory Filings, Regulatory Research, R&D, Clinical Research, Clinical Trials, Clinical Trial..., Clinical Data Management, Clinical Supervision, Animal Models, Animal Behavior, Animal Handling, Protocol, Infectious Diseases, Clinical Study Design, CTMS, Strategy
Education
Stony Brook University 2000 — 2005
Doctor of Philosophy (Ph.D.), Neuroscience
Trinity College-Hartford 1994 — 1998
Bachelor of Applied Science (B.A.Sc.), Neuroscience
Stuyvesant High School
Mitsubishi Tanabe Pharma Development America January 2011 - Present
Mitsubishi Tanabe Pharma Development America August 2010 - December 2010
sanofi-aventis September 2008 - April 2010
Raritan Valley Community College September 2008 - October 2008
sanofi-aventis September 2005 - September 2008
sanofi-aventis January 2005 - August 2005
Aventis January 2001 - December 2004
Novartis August 2000 - December 2000
Novartis October 1999 - December 2000
Novartis January 1997 - October 1999
Skills
Pharmaceutical Industry, GCP, Sop, Clinical Data Management, Training, Therapeutic Areas, Cross-functional Team..., Pharmacovigilance, 21 CFR Part 11, Biostatistics, Program Management, Clinical Monitoring, EDC, Regulatory Submissions, Clinical Study Design, Project Management, GMP, Regulatory Requirements, SOP
Education
Centenary College
Union County College
Sarepta Therapeutics August 2015 - Present
Mitsubishi Tanabe Pharma Development America July 2013 - July 2015
Optimer Pharmaceuticals May 2012 - July 2013
Vertex Pharmaceuticals July 2011 - May 2012
Novartis September 2010 - March 2011
MedImmune (Biologics division of AstraZeneca) July 2006 - September 2010
Centers for Disease Control and Prevention June 2003 - June 2006
National Institute for Occupational Safety and Health June 2003 - June 2005
Skills
Infectious Diseases, Epidemiology, Vaccines, Clinical Trials, Pharmacovigilance, Internal Medicine, Medicine, Clinical Development, Clinical Research, Drug Development, GCP, Medical Writing, Oncology, Patient Safety, Pharmaceutical Industry, Drug Safety
Education
University of Connecticut 2001 — 2003
M.P.H., Public Health
Georgetown University School of Medicine 1993 — 1997
M.D.
inBiotechnologies August 2015 - Present
LLOYD September 2014 - August 2015
George Washington University August 2013 - December 2014
CONRAD January 2014 - September 2014
Ipsen June 2012 - April 2013
Mitsubishi Tanabe Pharma Development America August 2010 - May 2012
medicines360 October 2009 - February 2010
Catalent Pharma Solutions June 2008 - October 2009
Bayer HealthCare June 2007 - May 2008
Eisai Medical Research February 2006 - May 2007
Skills
Regulatory Affairs, Regulatory Submissions, FDA, Clinical Development, Pharmaceutical Industry, Clinical Research, Drug Development, NDA, Strategy, Biotechnology, IND, Biopharmaceuticals, Regulatory Requirements, Therapeutic Areas, Clinical Trials, CMC, CRO, SOP, Cross-functional Team..., eCTD, Pharmaceutics, Clinical Study Design, Neurology, GCP, Medical Writing, Biologics, Consulting, Pharmacovigilance, GMP, Technology Transfer, Combination Products, Women's Health, Endocrinology, Oncology, Orphan Drugs, Life Sciences, Regulations, Management, Leadership
Education
Concord Law School - Kaplan University 2015 — 2019
Doctor of Law (JD)
Columbia University in the City of New York 1997 — 1999
MPH, Health Policy
The Johns Hopkins University 1996 — 1997
M.S., Biotechnology
Vanderbilt University 1991 — 1995
BA, Chemistry/Spanish
Regeneron Pharmaceuticals, Inc. February 2013 - Present
Accurate Clinical Management October 2012 - Present
Ipsen Pharmaceuticals March 2012 - January 2013
Mitsubishi Tanabe Pharma Development America July 2007 - March 2012
Sanofi-Aventis September 2008 - December 2008
Novartis Pharmaceuticals (Aerotek, LLC) October 2006 - July 2007
Skills
Clinical Trials, CRO, Clinical Development, Pharmaceutical Industry, GCP, CTMS, EDC
Education
University of Phoenix 1998 — 2008
North Carolina A & T State University 1986 — 1987
Business Administration and Management, General
Mitsubishi Tanabe Pharma Development America 2012 - Present
Prudential Securities October 1986 - December 2001
Skills
Contract Management, Risk Management, Pharmaceutical Industry, Contract Negotiation, Procurement, Project Management, Change Management
Education
Drew University
BA, Mathematics / Economics
Quintiles August 2014 - Present
Mitsubishi Tanabe Pharma Development America July 2010 - July 2014
INC Research August 2008 - July 2010
Medarex 2006 - 2008
Novartis July 2005 - February 2006
Bristol-Myers Squibb September 2003 - July 2005
ExxonMobil 1990 - September 2003
Skills
GCP, Auditing, GLP, Quality Assurance, Pharmaceutical Industry
Education
Longwood University
BS, Biology
Temple University
MS, Quality Assurance & Regulatory Affairs
Kyowa Hakko Kirin Pharma, Inc. (KKP) October 2014 - Present
ClinPlan LLC May 2012 - Present
Anderson Brecon/PCI October 2013 - April 2014
Mitsubishi Tanabe Pharma Development America May 2012 - April 2013
Mitsubishi Pharma America, Inc. (MPA) July 2008 - April 2012
Schering Plough November 2006 - July 2008
Medidata Solutions Worldwide March 2006 - November 2006
Taro Pharmaceuticals U.S.A., Inc., November 2005 - March 2006
Purdue Pharma L.P., R&D 1998 - 2005
Skills
Clinical Trials, GMP, Pharmaceutical Industry, Sop, FDA, GCP, 21 CFR Part 11, CRO, GxP, CTMS, CAPA, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, Quality Assurance, Protocol, Quality Auditing, SOP
Education
LIU Brooklyn 1984 — 1989
Bachelor's Degree, Pharmacy
Fairfield University
Applied Quality Solutions: CRA/CRC Program - Clinical Research Monitoring & Coordination
Middlesex County Community College, Middlesex, NJ
Business Solutions: Six Sigma Green Belt
Mitsubishi Tanabe Pharma Development America July 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - July 2013
Bristol-Myers Squibb October 2007 - January 2011
Covance January 2002 - October 2007
PAREXEL December 1999 - January 2002
MDS Pharma Services (Phoenix) December 1998 - December 1999
Roche 1997 - 1998
Skills
Strategic Sourcing, Indirect Procurement, Supplier Relationship..., Contract Negotiation, Contract Management, Total Value Analysis, Category Management, Global Sourcing, Team Leadership
Education
Northumbria University
Master of Laws (LLM)
The University of Sheffield
MSc
University of Oxford
BA(Hons)
Mitsubishi Tanabe Pharma Development America February 2013 - Present
Eisai March 1998 - November 2012
Skills
Clinical Data Management, EDC, CDISC, CRO, GCP, Clinical Trials, Clinical Development, 21 CFR Part 11, Pharmaceutical Industry, Data Management, Oncology, Therapeutic Areas, ICH-GCP, Regulatory Submissions
Education
State University of New York at Binghamton
Bachelor of Arts (B.A.), Biology
Mitsubishi Tanabe Pharma Development America March 2013 - Present
Skills
Microsoft Excel, Microsoft Word, PowerPoint, PCR, Cell Culture, SDS-PAGE, Western Blotting, Gel Electrophoresis, Tissue Culture, Southern Blot, Yeast two-hybrid, Site-directed..., Molecular Biology
Education
Columbia University in the City of New York 2011 — 2012
MA, Biotechnology
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2011
BA, Biological Sciences