Astellas Pharma Global Development, Inc.

Industry: Company

Description

Founded: 2009 Parent organization: Astellas Pharma

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Astellas Pharma Global Development, Inc. Employees

Employee
Years
Job
Industry
Scott Flanders, PhD Scott Flanders, PhD Greater Chicago Area Details
Scott Flanders, PhD's Astellas Pharma Global Development, Inc. Experience January 2013 - Present
Job Sr. Director, Health Economics and Clinical Outcomes Research Oncology (Astellas Medical Affairs Americas)
Industry Pharmaceuticals
Experience
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

Sharon Kelleher Sharon Kelleher Greater Chicago Area Details
Sharon Kelleher's Astellas Pharma Global Development, Inc. Experience June 2002 - Present
Job Associate Manager, Contracts at Astellas Pharma Global Development, Inc.
Industry Pharmaceuticals
Experience
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

Allam (Al) Fakhoury, PharmD Allam (Al) Fakhoury, PharmD Greater Chicago Area Details
Allam (Al) Fakhoury, PharmD's Astellas Pharma Global Development, Inc. Experience June 2008 - December 2010
Job Global Development Project Leader at Astellas Pharma
Industry Pharmaceuticals
Experience
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

Celia (Yixin) Chen Celia (Yixin) Chen Lake Zurich, Illinois Details
Celia (Yixin) Chen's Astellas Pharma Global Development, Inc. Experience January 2008 - May 2012
Job Principal Database Programmer, Sr. Manager at Astellas Pharma
Industry Pharmaceuticals
Experience
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

Frank Perabo Frank Perabo Houston, Texas Details
Frank Perabo's Astellas Pharma Global Development, Inc. Experience July 2011 - September 2014
Job CMO and Executive VP Clinical Development at Essa Pharmaceuticals, Corp.
Industry Pharmaceuticals
Experience
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)

Timothy Hoon Timothy Hoon Greater Chicago Area Details
Timothy Hoon's Astellas Pharma Global Development, Inc. Experience January 2012 - Present
Job National Director MSL Urology at Astellas Pharma Global Development, Inc.
Industry Pharmaceuticals
Experience
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

Patrick Bissell Patrick Bissell Sheboygan, Wisconsin Area Details
Patrick Bissell's Astellas Pharma Global Development, Inc. Experience August 2007 - June 2009
Job QA Quality Systems Document Management and Oracle JDE and PLM validations
Industry Medical Devices
Experience
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

Susan Ramsey Susan Ramsey Greater Chicago Area Details
Susan Ramsey's Astellas Pharma Global Development, Inc. Experience March 2008 - February 2010
Job
Industry Higher Education
Experience
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

Jennifer Alf Jennifer Alf Greater Chicago Area Details
Jennifer Alf's Astellas Pharma Global Development, Inc. Experience September 2011 - November 2013
Job Associate Director, Data Standards at Astellas Pharma
Industry Pharmaceuticals
Experience
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

Michelle Grimaud Michelle Grimaud Greater Chicago Area Details
Michelle Grimaud's Astellas Pharma Global Development, Inc. Experience October 2014 - Present
Job Associate Global Medical Writing Vendor Relationship Director at Astellas Pharma Global Development, Inc.
Industry Pharmaceuticals
Experience
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

Marsha Shetsky, PhD Marsha Shetsky, PhD Greater Chicago Area Details
Marsha Shetsky, PhD's Astellas Pharma Global Development, Inc. Experience August 2007 - February 2014
Job Director, Regulatory Affairs Advertising & Promotion at Baxalta
Industry Pharmaceuticals
Experience
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.

Lia Pocrnich Lia Pocrnich Greater Chicago Area Details
Lia Pocrnich's Astellas Pharma Global Development, Inc. Experience January 2008 - Present
Job at Astellas Pharma Global Development, Inc.
Industry Pharmaceuticals
Experience
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

Barbara A. Saiia, RN, BSN, MEd Barbara A. Saiia, RN, BSN, MEd Greater Milwaukee Area Details
Barbara A. Saiia, RN, BSN, MEd's Astellas Pharma Global Development, Inc. Experience October 2010 - June 2014
Job
Industry Pharmaceuticals
Experience
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

Leann Frankel Leann Frankel Mount Prospect, Illinois Details
Leann Frankel's Astellas Pharma Global Development, Inc. Experience November 2013 - Present
Job Director Operations, Global Contracts & Outsourcing at Astellas Pharma Global Development, Inc
Industry Pharmaceuticals
Experience
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

Marie-Jocelyne Colas Marie-Jocelyne Colas Miami/Fort Lauderdale Area Details
Marie-Jocelyne Colas's Astellas Pharma Global Development, Inc. Experience January 2009 - February 2011
Job Sr. Manager Compliance and Training
Industry Pharmaceuticals
Experience
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

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