Kyowa Hakko Kirin Pharma, Inc.

Industry: Pharmaceutical company

Description

Founded: 1992 Parent organization: Kyowa Hakko Kirin Co., Ltd.

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Kyowa Hakko Kirin Pharma, Inc. Employees

Employee
Years
Job
Industry
George Spitalny, PhD George Spitalny, PhD Greater Philadelphia Area Details
George Spitalny, PhD's Kyowa Hakko Kirin Pharma, Inc. Experience July 2010 - February 2012
Job Chief Scientific Officer at ERAD Therapeutics, Inc.
Industry Biotechnology
Experience
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

Jeffrey Humphrey Jeffrey Humphrey Greater New York City Area Details
Jeffrey Humphrey's Kyowa Hakko Kirin Pharma, Inc. Experience April 2013 - Present
Job Princeton, NJ
Industry Pharmaceuticals
Experience
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

Nobuyasu Tajime Nobuyasu Tajime United States Details
Nobuyasu Tajime's Kyowa Hakko Kirin Pharma, Inc. Experience October 2013 - Present
Job Clinical Trial Manager at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Donna Schubert Donna Schubert Millstone Township, New Jersey Details
Donna Schubert's Kyowa Hakko Kirin Pharma, Inc. Experience 2001 - Present
Job Vice President QA/DSS at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Mark Paskewitz Mark Paskewitz Greater Los Angeles Area Details
Mark Paskewitz's Kyowa Hakko Kirin Pharma, Inc. Experience 2005 - 2010
Job Vice President, Clinical Affairs at National Institute of Clinical Research
Industry Biotechnology
Experience
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

Carolyn Huntenburg Carolyn Huntenburg Greater Boston Area Details
Carolyn Huntenburg's Kyowa Hakko Kirin Pharma, Inc. Experience 2009 - 2010
Job VP, Regulatory Affairs at Momenta Pharmaceuticals
Industry Pharmaceuticals
Experience
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

Denis J. Healy, MS, MBA, PMP Denis J. Healy, MS, MBA, PMP Greater New York City Area Details
Denis J. Healy, MS, MBA, PMP's Kyowa Hakko Kirin Pharma, Inc. Experience March 2013 - Present
Job Senior Director, Drug Development (DTL KW0761) at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Lillian Ferreira Lillian Ferreira Greater New York City Area Details
Lillian Ferreira's Kyowa Hakko Kirin Pharma, Inc. Experience August 2009 - January 2011
Job Corporate Regulatory Affairs at Bracco Diagnostics
Industry Biotechnology
Experience
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

Hal Ward Hal Ward Greater Philadelphia Area Details
Hal Ward's Kyowa Hakko Kirin Pharma, Inc. Experience September 2011 - Present
Job Senior Director Drug Safety Surveillance at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Daniel Mannix, Ph.D. Daniel Mannix, Ph.D. Princeton, New Jersey Details
Daniel Mannix, Ph.D.'s Kyowa Hakko Kirin Pharma, Inc. Experience July 2014 - Present
Job Vice President, Regulatory Affairs at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

David Zammit David Zammit Greater New York City Area Details
David Zammit's Kyowa Hakko Kirin Pharma, Inc. Experience January 2014 - January 2015
Job Director, Clinical Development Oncology
Industry Biotechnology
Experience
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

Mei Hentrup Mei Hentrup Greater Philadelphia Area Details
Mei Hentrup's Kyowa Hakko Kirin Pharma, Inc. Experience June 2011 - December 2014
Job Global Clinical Project Management Consultant
Industry Pharmaceuticals
Experience
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

Deborah DeMaria Leonard Deborah DeMaria Leonard Greater Philadelphia Area Details
Deborah DeMaria Leonard's Kyowa Hakko Kirin Pharma, Inc. Experience July 2012 - Present
Job
Industry Writing and Editing
Experience
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

Niranjan Rao Niranjan Rao Greater New York City Area Details
Niranjan Rao's Kyowa Hakko Kirin Pharma, Inc. Experience September 2005 - January 2012
Job Vice President, Clinical Development at Asana Biosciences, LLC
Industry Pharmaceuticals
Experience
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

Dr. William Ofosu-Appiah Dr. William Ofosu-Appiah Greater Philadelphia Area Details
Dr. William Ofosu-Appiah's Kyowa Hakko Kirin Pharma, Inc. Experience October 2004 - December 2010
Job Clinical Trial Leader at Novartis Pharmaceuticals Corporation, Div. of Oncology Translational Medicine
Industry Pharmaceuticals
Experience
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

Takefumi Matsushita, Ph.D, MBA Takefumi Matsushita, Ph.D, MBA Princeton, New Jersey Details
Takefumi Matsushita, Ph.D, MBA's Kyowa Hakko Kirin Pharma, Inc. Experience Manager, Clinical OncologyKyowa Hakko Kirin Co., Ltd.December 2010 - March 2013
Job Director, Planning Department at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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.

Lynne Knauss Lynne Knauss Greater Philadelphia Area Details
Lynne Knauss's Kyowa Hakko Kirin Pharma, Inc. Experience November 2013 - Present
Job Manager, Clinical Trials at Kyowa Hakko Kirin Pharma, Inc.
Industry Research
Experience
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

Douglas Greene Douglas Greene Greater New York City Area Details
Douglas Greene's Kyowa Hakko Kirin Pharma, Inc. Experience April 2015 - Present
Job Senior Director, Clinical Pharmacology at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Nehal Mohamed Nehal Mohamed San Francisco Bay Area Details
Nehal Mohamed's Kyowa Hakko Kirin Pharma, Inc. Experience September 2007 - January 2013
Job Senior Director, Clinical Science at Onyx Pharmaceuticals
Industry Biotechnology
Experience
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

Tom Lauterio Tom Lauterio Greater New York City Area Details
Tom Lauterio's Kyowa Hakko Kirin Pharma, Inc. Experience April 2013 - Present
Job Senior Director, Project Management at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Carolyn Connors Carolyn Connors Murrells Inlet, South Carolina Details
Carolyn Connors's Kyowa Hakko Kirin Pharma, Inc. Experience August 2010 - April 2013
Job GCP Quality Consultant
Industry Pharmaceuticals
Experience
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

Lisa Conrad Lisa Conrad Greater New York City Area Details
Lisa Conrad's Kyowa Hakko Kirin Pharma, Inc. Experience September 2013 - Present
Job Manager, Quality Assurance at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Jennipher Truesdale Jennipher Truesdale Greater New York City Area Details
Jennipher Truesdale's Kyowa Hakko Kirin Pharma, Inc. Experience January 2013 - Present
Job
Industry Pharmaceuticals
Experience
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

Penny Bristow Penny Bristow Greater Philadelphia Area Details
Penny Bristow's Kyowa Hakko Kirin Pharma, Inc. Experience June 2009 - August 2014
Job President at CORE Clinical Solutions, LLC
Industry Pharmaceuticals
Experience
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

Meg Marshall Meg Marshall Princeton, New Jersey Details
Meg Marshall's Kyowa Hakko Kirin Pharma, Inc. Experience October 2014 - Present
Job Senior Director, Clinical Development at Kyowa Hakko Kirin Pharma
Industry Pharmaceuticals
Experience
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

Martha Osburn-Henry, CPS, IA Martha Osburn-Henry, CPS, IA Greater Philadelphia Area Details
Martha Osburn-Henry, CPS, IA's Kyowa Hakko Kirin Pharma, Inc. Experience October 2012 - August 2013
Job Administrative Assistant / Document Specialist at Weinberger Law Group, LLC
Industry Military
Experience
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

Barbara Novak Barbara Novak Greater New York City Area Details
Barbara Novak's Kyowa Hakko Kirin Pharma, Inc. Experience July 2009 - Present
Job Sr. Clinical Trials Manager at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Mollie Leoni, MD Mollie Leoni, MD Princeton, New Jersey Details
Mollie Leoni, MD's Kyowa Hakko Kirin Pharma, Inc. Experience March 2014 - Present
Job Director Safety Physician
Industry Pharmaceuticals
Experience
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

Janet Kaczmarczyk Janet Kaczmarczyk Greater Philadelphia Area Details
Janet Kaczmarczyk's Kyowa Hakko Kirin Pharma, Inc. Experience April 2011 - Present
Job Head of CMC at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Florentina Rinchita Silva Florentina Rinchita Silva Greater New York City Area Details
Florentina Rinchita Silva's Kyowa Hakko Kirin Pharma, Inc. Experience March 2014 - May 2015
Job Clinical Drug Supply Manager
Industry Pharmaceuticals
Experience
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

Ellen Geary Ellen Geary Greater Philadelphia Area Details
Ellen Geary's Kyowa Hakko Kirin Pharma, Inc. Experience January 2011 - June 2011
Job Sr. Clinical Trial Leader at Novartis Vaccines and Diagnostics
Industry Pharmaceuticals
Experience
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

Eric Sbar Eric Sbar Greater Philadelphia Area Details
Eric Sbar's Kyowa Hakko Kirin Pharma, Inc. Experience November 2012 - September 2013
Job Global Clinical Lead Dacomitinib at Pfizer
Industry Pharmaceuticals
Experience
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

DeCynda DeVoil DeCynda DeVoil Greater New York City Area Details
DeCynda DeVoil's Kyowa Hakko Kirin Pharma, Inc. Experience May 2015 - Present
Job Clinical Trials Coordinator at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Joyce George Joyce George Greater New York City Area Details
Joyce George's Kyowa Hakko Kirin Pharma, Inc. Experience September 2012 - December 2013
Job Sr. Manager, Biostatistics at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Mimma Formica, PharmD, RPh Mimma Formica, PharmD, RPh Greater New York City Area Details
Mimma Formica, PharmD, RPh's Kyowa Hakko Kirin Pharma, Inc. Experience May 2013 - Present
Job Drug Safety Surveillance at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

Brian Groff Brian Groff Greater San Diego Area Details
Brian Groff's Kyowa Hakko Kirin Pharma, Inc. Experience 2006 - Present
Job Senior Research Associate, Biochemistry Group at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
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

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