Astellas Pharma Global Development, Inc.
Industry: Company
DescriptionFounded: 2009 Parent organization: Astellas Pharma
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Astellas Pharma Global Development, Inc. Employees
Astellas Pharma Global Development, Inc. January 2013 - Present
Skills
Outcomes Research, Pharmacoeconomics, Managed Care, Health Services Research, Health Economics, Healthcare, Pharmaceuticals, Market Access
Education
Saint Louis University 1992 — 1999
PhD, Health Services Research
Trinity University 1989 — 1990
M.S., Health Administration
Trinity University 1983 — 1987
B.S., Business Administration
Astellas Pharma Global Development, Inc. June 2002 - Present
InfoTech Services, Inc. doing business as Trilogy Consulting November 1999 - May 2002
Trilogy Consulting Corporation July 1984 - July 1999
Education
Michigan State University
BA, Marketing
Astellas Pharma January 2011 - Present
Astellas Pharma Global Development, Inc. June 2008 - December 2010
Astellas Pharma US Inc. March 2005 - March 2008
Abbott Laboratories June 1997 - March 2005
Children's Memorial Hospital (Northwestern Medical) June 1992 - June 1997
Evanston Hospital 1988 - 1994
Skills
Oncology, Pharmaceutical Industry, Clinical Development, Clinical Research, Clinical Trials, Drug Development, Cross-functional Team..., Therapeutic Areas, Medical Affairs, GCP, Urology, Leadership, Healthcare, IND, Regulatory Submissions, Infectious Diseases, Hematology, Project Management, Cardiology, Clinical Monitoring, Regulatory Affairs, Hospitals, Strategic Planning, Pediatrics, Gastroenterology, CTMS, Pharmacovigilance, Diabetes, Pharmacokinetics, EDC, Medical Writing, Cancer, ICH-GCP, Clinical Operations, Translational Medicine, Pharmacology, Neurology, CRO, Pain Management, Osteoarthritis, Neuropathy, Companion Diagnostics, Asthma, Anesthesia, Biotechnology, Immunology, SOP, Life Sciences, FDA
Education
Universtity of Illinois College of Pharmacy 1987 — 1992
Doctor of Pharmacy (PharmD), Clinical, Hospital, and Managed Care Pharmacy
University of Illinois at Chicago 1984 — 1987
pre-pharmacy, Clinical Pharmacy
Astellas Pharma December 1996 - Present
Astellas Pharma May 2012 - March 2013
Astellas Pharma Global Development, Inc. January 2008 - May 2012
Astellas Pharma Global Development, Inc. March 2008 - July 2010
Astellas Pharma US, Inc. September 2006 - March 2008
Capgemini America, Inc February 2006 - September 2006
Astellas Pharma US, Inc. April 2005 - February 2006
Fujisawa Healthcare Inc. September 2001 - March 2005
Fujisawa Healthcare Inc January 1999 - August 2001
Fujisawa Healthcare Inc. December 1996 - December 1998
Skills
Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Pharmaceutical Sales, Sales Effectiveness, GCP, CRO, Market Access, GMP, Regulatory Affairs, Biotechnology, Therapeutic Areas
Education
Loyola University Chicago 1993 — 1994
Master of Computer Science
Tianjin University
B.S. in Electronic Engineering
Essa Pharmaceuticals, Corp. September 2014 - Present
Astellas Pharma Global Development, Inc. July 2011 - September 2014
Astellas Pharma Global Development, Inc. August 2010 - June 2011
Astellas Pharma Europe, BV. January 2008 - August 2010
Astellas Pharma GmbH May 2006 - December 2007
P&S Partner GmbH July 2002 - April 2006
Oncology World GmbH March 2001 - June 2002
Dept. of Urology, University Hospital Bonn February 1998 - March 2001
Dept of Urology, University Hospital Freiburg July 1995 - January 1998
Dept of Surgery, Technical University of Munich July 1993 - June 1995
Skills
Pharmaceutical Industry, Clinical Development, Oncology, Urology, Clinical Trials, GCP, Drug Development, Therapeutic Areas, Biotechnology, CRO, CTMS, Medical Affairs, Pharmacovigilance, Medicine, Medical Writing
Education
European Board of Urology 2006 — 2010
Fellow of the European Board of Urology (FEBU), Urology
Rheinische Friedrich-Wilhelms-Universität Bonn 1998 — 2006
Graduation to University Professor (Habilitation), Urooncology
Technische Universität München 1993 — 1995
Doctor of Philosophy (PhD)
Ludwig-Maximilians Universität München 1985 — 1993
Doctor of Medicine (MD)
Astellas Pharma Global Development, Inc. January 2012 - Present
Astellas Pharma August 2008 - December 2011
Sanofi-Synthelabo 1999 - 2003
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Urology, Oncology, Cardiology, Dermatology, Medical Affairs
Education
University of Illinois Health Sciences Center 1983 — 1985
Doctor of Pharmacy (Pharm.D.)
University of Illinois Health Sciences Center 1978 — 1982
Bachelor's Degree, Pharmacy
University of Illinois at Urbana-Champaign 1976 — 1978
Pre-Pharmacy Studies
Rockline Industries November 2014 - Present
Astellas US Technologies Inc August 2010 - August 2014
Astellas Information Technology January 2010 - June 2010
Astellas Pharma Global Development, Inc. August 2007 - June 2009
Jett Services Inc. November 2001 - January 2007
KAR Products October 1991 - October 2001
American Health Information Management Association December 1990 - December 1991
Money Network - Association for Shared Electronic Funds Transfer February 1982 - December 1990
Associated General Contractors of Illinois August 1977 - December 1981
Fifth District Council of Governments September 1974 - August 1977
Skills
Outlook, Microsoft Word, Visio, Microsoft Office, Microsoft Excel, Quality Assurance, Project Management, Cross-functional Team..., 21 CFR Part 11, Software Documentation, Sop, Validation, Process Improvement, Project Planning, CAPA, FDA, Change Control, Computer System..., GxP, GMP, Quality System, GAMP, Pharmaceutical Industry, Regulatory Requirements, V&V, GLP, GCP, Regulatory Affairs, Regulatory Submissions, Trackwise, Biopharmaceuticals, Aseptic Processing, Clinical Development, Document Management, Quality Control, CTMS, IND, CRO, Cleaning Validation, SDLC, Pharmaceutics, SharePoint, Clinical Trials, Technology Transfer, Quality Auditing, Biotechnology, TrackWise, SOP
Education
University of New Orleans 1972 — 1974
MA, Public Administration, Finance and Public Policy
The University of South Dakota 1966 — 1970
BA, Economics and Government
ESL Associates October 2013 - Present
College of Lake County August 2011 - Present
Lake County Adult Learning Connection June 2010 - August 2011
Astellas Pharma Global Development, Inc. March 2008 - February 2010
TAP Pharmaceuticals 2004 - 2008
SRC, Inc. / Independent Consultant 1987 - 1997
Abbott Laboratories 1983 - 1986
Skills
CTMS, Validation, Pharmaceutical Industry, Cross-functional Team..., Process Improvement, Project Management, Training, Software Documentation, FDA, ESL, Quality Assurance, Adult Education, Instructional Design
Education
University of Illinois at Urbana-Champaign
BS, Biology
National Louis University
M.Ed, Adult Education
College of Lake County
TESOL Certificate, Adult ESL
Astellas Global Development March 2014 - Present
Astellas Pharma Global Development, Inc. September 2011 - November 2013
Astellas Pharma Global Development, Inc. March 2008 - September 2011
Astellas Pharma Global Development, Inc. 2006 - March 2008
Fujisawa Healthcare, Inc. 2004 - 2006
Fujisawa Healthcare, Inc. 2002 - 2004
Skills
EDC, Data Management, Clinical Data Management, FDA, CRO, Clinical Trials, Regulatory Affairs, Clinical Development, CTMS, GCP, 21 CFR Part 11, ICH-GCP, CDISC
Education
University of Illinois at Chicago
Bachelor of Science (B.S.), Chemistry
Astellas Pharma Global Development, Inc. October 2014 - Present
Astellas Pharma Global Development, Inc. 2010 - Present
Astellas Pharma Global Development, Inc. April 2009 - July 2010
Astellas Pharma US, Inc. April 2007 - March 2009
Astellas Pharma US, Inc. October 2003 - March 2007
Skills
Clinical Development, GCP, eCTD, CRO, Regulatory Submissions, Oncology, Clinical Trials, Dermatology, Rheumatology, Infectious Diseases, FDA, Clinical Research, Neurology, Regulatory Affairs, Diabetes, Clinical Monitoring, Immunology, CTMS, Sop, Protocol, Pharmacovigilance, ICH-GCP, EDC, Pharmacology, Pharmaceutical Industry, Biotechnology, Therapeutic Areas, 21 CFR Part 11, Clinical Data Management
Education
Southern Illinois University, Edwardsville 1977 — 1981
Bachelor of Arts (B.A.), English Language and Literature, General
Baxalta July 2015 - Present
The Chicago School of Professional Psychology July 2015 - Present
Baxter International Inc. February 2014 - June 2015
Astellas Pharma Global Development, Inc. August 2007 - February 2014
Abbott Laboratories February 2003 - August 2007
Skills
Drug Development, Pharmaceutical Industry, Validation, FDA, Regulatory Affairs, Clinical Development, Regulatory Submissions, Regulatory Requirements, Oncology, Clinical Trials, Sop, Pharmacovigilance, Regulations, 21 CFR Part 11, GCP, Biotechnology, SOP
Education
The Chicago School of Professional Psychology 2010 — 2013
Ph.D., Organizational Leadership
Benedictine University 1984 — 1986
M.P.H.
Astellas Pharma Global Development, Inc. January 2008 - Present
Astellas Pharma Global Development 2007 - Present
Astellas Pharma 2006 - Present
Pfizer (formerly Pharmacia / G. D. Searle) 1997 - 2000
Lorex Pharmaceuticals 1984 - 1997
Education
Lake Forest Graduate School of Management 1993 — 1995
Clinical Research+Plus, LLC 2001 - Present
Catabasis Pharmaceuticals, Inc. November 2014 - Present
C. R. Bard, Inc May 2013 - Present
Multiple Pharma Clients August 2010 - Present
Marathon Phamaceuticals September 2014 - March 2015
Wockhardt July 2014 - March 2015
Gilead Sciences July 2014 - January 2015
EVOKE Pharma July 2014 - December 2014
Novan Therapeutics May 2014 - December 2014
Astellas Pharma Global Development, Inc. October 2010 - June 2014
Skills
Phase I: QTc experienced, First in Man, Equivancy studies, PK & PD, Clinical Monitoring, CTMS, Clinical Development, EDC, Clinical Research, CRO, GCP, Medical Writing, Infectious Diseases, Regulatory Submissions, Cardiology, Neurology, Pharmaceutical Industry, Protocol, Dermatology, Pharmacovigilance, Regulatory Affairs, Gastroenterology, Urology, Biotechnology, Biopharmaceuticals, Therapeutic Areas, Pharmacology, FDA, Phase I, Immunology, Lifesciences, Cancer, Drug Development, Vaccines, ICH-GCP, Clinical Data Management
Education
Marquette University 1981 — 1983
Master of Education (MEd), MEd in psychology
Alverno College 1978 — 1980
BSN, Nursing
Astellas Pharma Global Development, Inc November 2013 - Present
Astellas Pharma Global Development, Inc. 2010 - 2013
Astellas Pharma April 2001 - December 2010
American Medical Association August 1994 - April 2001
Skills
CTMS, Clinical Development, Pharmaceutical Industry, CRO, Clinical Trials, GCP, Contract Negotiation, Contract Management, Project Management, Cross-functional Team..., Pharmacovigilance, Regulatory Affairs, Biotechnology, Clinical Research, Oncology, Regulatory Submissions, Drug Development
Education
Seton Hall University School of Law 2013 — 2013
Certificate, Phamraceutical & Medical Device Law & Compliance: Compliance Issues in Life Sciences
DePaul University 2001 — 2005
MPH, Healthcare Law/Administration
Allergan Pharmaceuticals August 2012 - Present
Baxter Healthcare May 2011 - August 2012
Astellas Pharma Global Development, Inc. January 2009 - February 2011
Biopoint Pharmaceutical & Biotech Consulting May 2008 - December 2008
Kos Pharmaceuticals (A wholly Owned Subsidiary of Abbott Laboratories) 2000 - 2008
Skills
Quality Assurance, Pharmacovigilance, Regulatory Affairs, Pharmaceutical Industry, GCP, Biotechnology, Auditing, Regulatory Submissions, GMP, Compliance, SOP development, Inspection readiness, Project Management, Process Improvement, Key Performance..., Quality control, FDA, Quality System
Education
Nova Southeastern University—Shepard Broad Law Center 2004 — 2006
Master's in Health Law/ Regulatory & Compliance
Saint Louis University School of Nursing 1984 — 1986
Bachelor Science of Nursing