Ono Pharma USA
Description
Address: 2000 Lenox Dr, Trenton, NJ 08648 Hours: Open now · Add full hours Unable to add this file. Please check that it is a valid photo. Phone: (609) 219-1010Category: : : : : Place name: Website: : : Hours: Website: https://www.ono.co.jp/eng/ Category: Pharmaceutical company Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Ono Pharma USA Inc Posting publicly on the Web Write a review Reviews Be the first to review
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Ono Pharma USA Employees
Employee
Years
Job
Industry
Gregory Cuca Gregory Cuca's Ono Pharma USA Experience 2001 - 2003
Job Director Unit Head Oncology Submission Management at Novartis Pharmaceuticals
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals February 2013 - Present
Novartis Pharmaceuticals June 2009 - February 2013
Galderma 2005 - 2009
Merck & Co 2003 - 2005
Ono Pharma USA 2001 - 2003
Merck & Co. 1994 - 2001
Skills
IND, Oncology, Lifesciences, Pharmaceutics, Clinical Development, Pharmaceutical Industry, Clinical Trials, Medical Writing, Regulatory Submissions, Drug Development, Biotechnology, Therapeutic Areas, GCP, Regulatory Affairs, Clinical Research, Dermatology, ICH-GCP, Medical Affairs, Protocol, Pharmacokinetics, Regulatory Requirements, FDA
Education
Southern Illinois University, Edwardsville
MS, Genetics / Biological Sciences
Blackburn College
BA, Biology / Chemistry
Novartis Pharmaceuticals February 2013 - Present
Novartis Pharmaceuticals June 2009 - February 2013
Galderma 2005 - 2009
Merck & Co 2003 - 2005
Ono Pharma USA 2001 - 2003
Merck & Co. 1994 - 2001
Skills
IND, Oncology, Lifesciences, Pharmaceutics, Clinical Development, Pharmaceutical Industry, Clinical Trials, Medical Writing, Regulatory Submissions, Drug Development, Biotechnology, Therapeutic Areas, GCP, Regulatory Affairs, Clinical Research, Dermatology, ICH-GCP, Medical Affairs, Protocol, Pharmacokinetics, Regulatory Requirements, FDA
Education
Southern Illinois University, Edwardsville
MS, Genetics / Biological Sciences
Blackburn College
BA, Biology / Chemistry
John P. Hall John P. Hall's Ono Pharma USA Experience January 2010 - June 2012
Job President at Shore Research & Development, LLC
Industry Research
Experience
Amakem Therapeutics June 2012 - Present
Shore Research & Development, LLC May 2012 - Present
Ono Pharma USA January 2010 - June 2012
Ono Pharma USA August 2007 - December 2009
IHC March 2002 - August 2007
Rhode Island Public Health Foundation March 2000 - March 2002
Skills
Clinical Development, CRO, Clinical Trials, Clinical Research, Therapeutic Areas, Sop, Pharmaceutical Industry, CTMS, EDC, Oncology, Microsoft Office, Clinical Monitoring, Microsoft Word, Research, Ophthalmology, Microsoft Excel, GCP, Hematology, Vendor Management, Phase I, Negotiation, Cardiology, Process Improvement, Budgets, ICH-GCP, Financial Analysis, Contract Negotiation, Biotechnology, Medical Writing, Operations Management, Budgeting, PowerPoint, Diabetes, Medical Devices, Regulatory Submissions, Neurology, Clinical Trial..., Regulatory Affairs, Vaccines, Clinical Data Management, FDA, Pharmaceuticals, Problem Solving, Word, Excel, Mentoring, Drug Development, Clinical Operations, SOP
Education
Rider University 2009 — 2011
MBA, Business
University of Rhode Island 1991 — 1995
BS, Human Science and Services
Seton Hall Preparatory
Amakem Therapeutics June 2012 - Present
Shore Research & Development, LLC May 2012 - Present
Ono Pharma USA January 2010 - June 2012
Ono Pharma USA August 2007 - December 2009
IHC March 2002 - August 2007
Rhode Island Public Health Foundation March 2000 - March 2002
Skills
Clinical Development, CRO, Clinical Trials, Clinical Research, Therapeutic Areas, Sop, Pharmaceutical Industry, CTMS, EDC, Oncology, Microsoft Office, Clinical Monitoring, Microsoft Word, Research, Ophthalmology, Microsoft Excel, GCP, Hematology, Vendor Management, Phase I, Negotiation, Cardiology, Process Improvement, Budgets, ICH-GCP, Financial Analysis, Contract Negotiation, Biotechnology, Medical Writing, Operations Management, Budgeting, PowerPoint, Diabetes, Medical Devices, Regulatory Submissions, Neurology, Clinical Trial..., Regulatory Affairs, Vaccines, Clinical Data Management, FDA, Pharmaceuticals, Problem Solving, Word, Excel, Mentoring, Drug Development, Clinical Operations, SOP
Education
Rider University 2009 — 2011
MBA, Business
University of Rhode Island 1991 — 1995
BS, Human Science and Services
Seton Hall Preparatory
ChristieLynne Williamson ChristieLynne Williamson's Ono Pharma USA Experience October 2012 - February 2014
Job Global Labeling Project Leader, Immunology at Janssen Research & Development, LLC
Industry Pharmaceuticals
Experience
Janssen Research & Development, LLC March 2015 - Present
Williamson Clinical Consulting, LLC July 2011 - Present
State of New Jersey March 2010 - Present
Regeneron Pharmaceuticals, Inc. May 2014 - November 2014
Ono Pharma USA October 2012 - February 2014
Merck July 2011 - December 2011
Merck July 2009 - July 2011
Rutgers University July 2009 - July 2011
CVS Caremark Corporation July 2008 - June 2009
The Medicine Shoppe Pharmacy September 2002 - July 2008
Skills
Health Education, Fast Learner, Medical Education, Medical Writing, Clinical Research, Compassion, Clinical Trials, Innovative Thinking, Electronic Case Report..., Microsoft Office, Pharmacology, Pharmacy, Healthcare, Clinical Study Design, Infectious Diseases, Pharmacovigilance, Diabetes, Protocol, Pharmacists, Clinical Development, Pharmaceutical Industry, FDA, Regulatory Submissions, Biotechnology, Medicine, Oncology, Regulatory Affairs, Clinical Pharmacology, Medical Affairs, Drug Development, GCP, Pharmaceutics, Outcomes Research, Managed Care, Pharmacokinetics, Pharmacoeconomics, CRO, Medication Therapy...
Education
Duquesne University 2003 — 2009
PharmD, Pharmacy
Janssen Research & Development, LLC March 2015 - Present
Williamson Clinical Consulting, LLC July 2011 - Present
State of New Jersey March 2010 - Present
Regeneron Pharmaceuticals, Inc. May 2014 - November 2014
Ono Pharma USA October 2012 - February 2014
Merck July 2011 - December 2011
Merck July 2009 - July 2011
Rutgers University July 2009 - July 2011
CVS Caremark Corporation July 2008 - June 2009
The Medicine Shoppe Pharmacy September 2002 - July 2008
Skills
Health Education, Fast Learner, Medical Education, Medical Writing, Clinical Research, Compassion, Clinical Trials, Innovative Thinking, Electronic Case Report..., Microsoft Office, Pharmacology, Pharmacy, Healthcare, Clinical Study Design, Infectious Diseases, Pharmacovigilance, Diabetes, Protocol, Pharmacists, Clinical Development, Pharmaceutical Industry, FDA, Regulatory Submissions, Biotechnology, Medicine, Oncology, Regulatory Affairs, Clinical Pharmacology, Medical Affairs, Drug Development, GCP, Pharmaceutics, Outcomes Research, Managed Care, Pharmacokinetics, Pharmacoeconomics, CRO, Medication Therapy...
Education
Duquesne University 2003 — 2009
PharmD, Pharmacy
Ming Q. Lu, MD, PhD Ming Q. Lu, MD, PhD's Ono Pharma USA Experience October 2007 - April 2012
Job Executive Director of Clinical, Senior Medical Director at Helsinn Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Helsinn Therapeutics, Inc. April 2012 - Present
Ono Pharma USA October 2007 - April 2012
Galderma March 2006 - October 2007
NexMed, Inc. 1998 - March 2006
West Pharmaceutical Services 1997 - 1998
Skills
Clinical Trials, Clinical Development, Clinical Research, Pharmacovigilance, Oncology, Immunology, Diabetes, Pharmaceuticals, Therapeutic areas, Infectious Diseases, Neurology, IND/NDA in China, Pharmaceutical Industry, Therapeutic Areas, Medical Affairs, Medicine, Dermatology, Drug Development, FDA, CRO, Phase I, IND, Protocol, GCP
Education
The Johns Hopkins University School of Medicine 1994 — 1997
Postdoc
University of Connecticut 1990 — 1994
Ph.D
Icahn School of Medicine at Mount Sinai 1989 — 1990
Postdoc
Qingdao Medical College
MD
Helsinn Therapeutics, Inc. April 2012 - Present
Ono Pharma USA October 2007 - April 2012
Galderma March 2006 - October 2007
NexMed, Inc. 1998 - March 2006
West Pharmaceutical Services 1997 - 1998
Skills
Clinical Trials, Clinical Development, Clinical Research, Pharmacovigilance, Oncology, Immunology, Diabetes, Pharmaceuticals, Therapeutic areas, Infectious Diseases, Neurology, IND/NDA in China, Pharmaceutical Industry, Therapeutic Areas, Medical Affairs, Medicine, Dermatology, Drug Development, FDA, CRO, Phase I, IND, Protocol, GCP
Education
The Johns Hopkins University School of Medicine 1994 — 1997
Postdoc
University of Connecticut 1990 — 1994
Ph.D
Icahn School of Medicine at Mount Sinai 1989 — 1990
Postdoc
Qingdao Medical College
MD
Brenda Souza Brenda Souza's Ono Pharma USA Experience September 2006 - February 2014
Job Executive Assistant/Senior Administrative Assistant Seeking opportunties
Industry Pharmaceuticals
Experience
Ono Pharma USA September 2006 - February 2014
Novo Nordisk March 2006 - August 2006
Medpointe October 2005 - January 2006
EDUCATIONAL TESTING SERVICE, Princeton, NJ (temp position) January 2005 - October 2005
Beardsworth Consulting Group April 2001 - February 2004
Covance July 1995 - April 2001
Skills
Clinical Trials, CRO, GCP, Pharmaceutical Industry, EDC, Clinical Development, Oncology, Drug Development, ICH-GCP, Therapeutic Areas, FDA, Biotechnology, Regulatory Affairs, Clinical Research, Assertiveness, Teamwork, Quality Control, Proofreading, Reconciling Reports, Event Planning, Multi Tasking, clinical study reports, Protocol, Office Administration, Project Management
Education
Mercer County Community College 1989 — 2004
Certificate of Proficiency, Office Skills Technology
Ono Pharma USA September 2006 - February 2014
Novo Nordisk March 2006 - August 2006
Medpointe October 2005 - January 2006
EDUCATIONAL TESTING SERVICE, Princeton, NJ (temp position) January 2005 - October 2005
Beardsworth Consulting Group April 2001 - February 2004
Covance July 1995 - April 2001
Skills
Clinical Trials, CRO, GCP, Pharmaceutical Industry, EDC, Clinical Development, Oncology, Drug Development, ICH-GCP, Therapeutic Areas, FDA, Biotechnology, Regulatory Affairs, Clinical Research, Assertiveness, Teamwork, Quality Control, Proofreading, Reconciling Reports, Event Planning, Multi Tasking, clinical study reports, Protocol, Office Administration, Project Management
Education
Mercer County Community College 1989 — 2004
Certificate of Proficiency, Office Skills Technology
Daniel Brois Daniel Brois's Ono Pharma USA Experience April 2012 - May 2013
Job
Industry Pharmaceuticals
Experience
Ono Pharma USA April 2012 - May 2013
Bayer HealthCare June 2009 - March 2012
Daiichi Sankyo May 2005 - May 2009
Novartis October 2003 - May 2005
Skills
Clinical Development, Management, GCP, Pharmaceutical Industry, Oncology, Clinical Trials, Market Research, Drug Development, Biotechnology, CRO, CTMS, Cardiology, Clinical Data Management, Clinical Monitoring, Clinical Pharmacology, Clinical Research, Diabetes, Drug Discovery, EDC, FDA, ICH-GCP, IND, Immunology, Infectious Diseases, Lifesciences, Medical Affairs, Medical Writing, Neurology, Pharmacology, Pharmacovigilance, Project Management, Regulatory Affairs, Regulatory Submissions, Sop, Therapeutic Areas, Vaccines, Life Sciences, SOP
Education
Rutgers, The State University of New Jersey-Newark 1999 — 2003
Master of Business Administration (M.B.A.), Strategic Management
University of Medicine and Dentistry of New Jersey 1990 — 1996
Doctor of Philosophy (PhD), Pathology/Experimental Pathology
Seton Hall University 1988 — 1990
Master of Science (MS), Microbiology, General
Cook College, Rutgers University 1984 — 1987
Bachelor of Science (BS), Biology, General
Ono Pharma USA April 2012 - May 2013
Bayer HealthCare June 2009 - March 2012
Daiichi Sankyo May 2005 - May 2009
Novartis October 2003 - May 2005
Skills
Clinical Development, Management, GCP, Pharmaceutical Industry, Oncology, Clinical Trials, Market Research, Drug Development, Biotechnology, CRO, CTMS, Cardiology, Clinical Data Management, Clinical Monitoring, Clinical Pharmacology, Clinical Research, Diabetes, Drug Discovery, EDC, FDA, ICH-GCP, IND, Immunology, Infectious Diseases, Lifesciences, Medical Affairs, Medical Writing, Neurology, Pharmacology, Pharmacovigilance, Project Management, Regulatory Affairs, Regulatory Submissions, Sop, Therapeutic Areas, Vaccines, Life Sciences, SOP
Education
Rutgers, The State University of New Jersey-Newark 1999 — 2003
Master of Business Administration (M.B.A.), Strategic Management
University of Medicine and Dentistry of New Jersey 1990 — 1996
Doctor of Philosophy (PhD), Pathology/Experimental Pathology
Seton Hall University 1988 — 1990
Master of Science (MS), Microbiology, General
Cook College, Rutgers University 1984 — 1987
Bachelor of Science (BS), Biology, General
Cheryl Rowe-Rendleman Cheryl Rowe-Rendleman's Ono Pharma USA Experience 2011 - March 2014
Job Consultant at Omar Consulting Group, LLC
Industry Pharmaceuticals
Experience
Omar Consulting 2005 - Present
Princeton Area Alumni Association August 2008 - Present
Ono Pharma USA 2011 - March 2014
IntraMed Educational Group 2003 - 2005
Insite Vision 2000 - 2003
Geron 1997 - 2000
Skills
Clinical Trials, Clinical Development, Research, Medical Education, Pharmaceutical Industry, Drug Development, Training, Clinical Research, Healthcare, Management, Medical Writing, Lifesciences, Strategy, Biotechnology, Oncology, Medicine, Neurology, FDA, Leadership
Education
University of California, San Francisco - School of Medicine 1995 — 1997
Fellow Degenerative ocular diseases, Growth factors and degenerative retinal diseases
Princeton University
AB, Biology
The University of Texas Medical School at Houston
Fellow, Developmental Retinal Cell Biology
University of Houston
PhD, Biochemistry and Biophysics
Omar Consulting 2005 - Present
Princeton Area Alumni Association August 2008 - Present
Ono Pharma USA 2011 - March 2014
IntraMed Educational Group 2003 - 2005
Insite Vision 2000 - 2003
Geron 1997 - 2000
Skills
Clinical Trials, Clinical Development, Research, Medical Education, Pharmaceutical Industry, Drug Development, Training, Clinical Research, Healthcare, Management, Medical Writing, Lifesciences, Strategy, Biotechnology, Oncology, Medicine, Neurology, FDA, Leadership
Education
University of California, San Francisco - School of Medicine 1995 — 1997
Fellow Degenerative ocular diseases, Growth factors and degenerative retinal diseases
Princeton University
AB, Biology
The University of Texas Medical School at Houston
Fellow, Developmental Retinal Cell Biology
University of Houston
PhD, Biochemistry and Biophysics
Koichiro Terai Koichiro Terai's Ono Pharma USA Experience April 2013 - Present
Job Senior Director at Ono Pharma USA
Industry Pharmaceuticals
Experience
Ono Pharma USA April 2013 - Present
Ono Pharmaceutical Co. Ltd. April 2012 - March 2013
Director, Business Development November 2008 - November 2011
Skills
Clinical Trials, Pharmacology, Drug Development, Clinical Development, GCP, Pharmaceutical Industry, CTMS, Oncology, CRO, Drug Discovery, Commercialization, Biopharmaceuticals, Life Sciences, Technology Transfer
Education
Kyoto University
Master's degree, Pharmacology
Ono Pharma USA April 2013 - Present
Ono Pharmaceutical Co. Ltd. April 2012 - March 2013
Director, Business Development November 2008 - November 2011
Skills
Clinical Trials, Pharmacology, Drug Development, Clinical Development, GCP, Pharmaceutical Industry, CTMS, Oncology, CRO, Drug Discovery, Commercialization, Biopharmaceuticals, Life Sciences, Technology Transfer
Education
Kyoto University
Master's degree, Pharmacology
Matthew Fenner Matthew Fenner's Ono Pharma USA Experience March 2012 - February 2014
Job Clinical Operations Lead at Anges MG, Inc
Industry Pharmaceuticals
Experience
Anges MG, Inc June 2014 - Present
Ono Pharma USA March 2012 - February 2014
Tolerx, Inc. September 2009 - April 2011
Tolerx, Inc March 2006 - September 2009
ReSearch Pharmaceutical Services September 2005 - March 2006
ReSearch Pharmaceutical Services February 2004 - August 2005
ViaCell Inc. November 2002 - January 2004
Shire Biologics, Inc January 2000 - January 2002
Hypertronics January 1997 - 2000
Education
Clarkson University
B.S, Technical Communications
SUNY Morrisville 1991 — 1993
A.A.S., Journalism
Anges MG, Inc June 2014 - Present
Ono Pharma USA March 2012 - February 2014
Tolerx, Inc. September 2009 - April 2011
Tolerx, Inc March 2006 - September 2009
ReSearch Pharmaceutical Services September 2005 - March 2006
ReSearch Pharmaceutical Services February 2004 - August 2005
ViaCell Inc. November 2002 - January 2004
Shire Biologics, Inc January 2000 - January 2002
Hypertronics January 1997 - 2000
Education
Clarkson University
B.S, Technical Communications
SUNY Morrisville 1991 — 1993
A.A.S., Journalism
Nicole Blair's Ono Pharma USA Experience June 2012 - November 2013
Job at
Industry Hospitality
Experience
onefinestay February 2015 - Present
onefinestay October 2014 - February 2015
onefinestay December 2013 - October 2014
Ono Pharma USA June 2012 - November 2013
NEOGOV January 2012 - April 2012
Anchor Bay Films September 2011 - December 2011
MetLife of Southern California - Financial Services June 2011 - September 2011
Anchor Bay Films June 2010 - December 2010
Skills
Script Coverage, Social Media, Administration, Lotus Notes, Salesforce.com, Microsoft Office, Employee Benefits, Employee Wellness..., Event Planning, Travel Management
Education
Loyola Marymount University 2008 — 2012
Bachelor of Business Administration (B.B.A.), Business Administration
onefinestay February 2015 - Present
onefinestay October 2014 - February 2015
onefinestay December 2013 - October 2014
Ono Pharma USA June 2012 - November 2013
NEOGOV January 2012 - April 2012
Anchor Bay Films September 2011 - December 2011
MetLife of Southern California - Financial Services June 2011 - September 2011
Anchor Bay Films June 2010 - December 2010
Skills
Script Coverage, Social Media, Administration, Lotus Notes, Salesforce.com, Microsoft Office, Employee Benefits, Employee Wellness..., Event Planning, Travel Management
Education
Loyola Marymount University 2008 — 2012
Bachelor of Business Administration (B.B.A.), Business Administration
Kevin Emes Kevin Emes's Ono Pharma USA Experience March 2005 - June 2006
Job
Industry Biotechnology
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson 1996 - Present
Centocor 1998 - 2008
Ono Pharma USA March 2005 - June 2006
McNeil CPC 1996 - 1998
Rhone-Poulenc Rorer 1996 - 1998
Bio-Pharm/IBAH/Omnicare 1993 - 1994
Skills
Decision Support, Risk Assessment, Decision Analysis, Clinical Development, Oncology, Pharmaceutical Industry, Regulatory Submissions, Drug Development, Biotechnology, CTMS, FDA, Biologics, CRO, IND, Biomarker Discovery, GCP, Therapeutic Areas, Immunology, Clinical Trials, Clinical Research, Biopharmaceuticals, Drug Discovery, Medical Affairs, Clinical Monitoring, Biomarkers, EDC, Clinical Operations, Infectious Diseases
Education
Bloomsburg University of Pennsylvania 1979 — 1983
BS, Biology
Manheim Twp 1975 — 1978
Academic
Janssen, Pharmaceutical Companies of Johnson and Johnson 1996 - Present
Centocor 1998 - 2008
Ono Pharma USA March 2005 - June 2006
McNeil CPC 1996 - 1998
Rhone-Poulenc Rorer 1996 - 1998
Bio-Pharm/IBAH/Omnicare 1993 - 1994
Skills
Decision Support, Risk Assessment, Decision Analysis, Clinical Development, Oncology, Pharmaceutical Industry, Regulatory Submissions, Drug Development, Biotechnology, CTMS, FDA, Biologics, CRO, IND, Biomarker Discovery, GCP, Therapeutic Areas, Immunology, Clinical Trials, Clinical Research, Biopharmaceuticals, Drug Discovery, Medical Affairs, Clinical Monitoring, Biomarkers, EDC, Clinical Operations, Infectious Diseases
Education
Bloomsburg University of Pennsylvania 1979 — 1983
BS, Biology
Manheim Twp 1975 — 1978
Academic
Ibrahima Soumaoro, MD's Ono Pharma USA Experience July 2011 - April 2012
Job Director, Clinical Research at Amphastar Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Amphastar Pharmaceuticals, Inc. September 2014 - Present
Allergan May 2012 - September 2014
Ono Pharma USA July 2011 - April 2012
Eisai Inc August 2008 - August 2011
Organon USA Inc March 2005 - July 2008
Long Island University 2002 - 2005
Skills
Clinical Research, Clinical Development, Pharmacology, Clinical Trials, Oncology, Therapeutic Areas, Pharmaceutical Industry, GCP, Drug Development, Clinical Pharmacology, Medical Writing, Regulatory Submissions, Drug Safety, CRO, Infectious Diseases, Immunology, CTMS, EDC, Cardiology, Medical Affairs, Clinical Data Management, Toxicology, IND, ICH-GCP, Pharmacovigilance, FDA, Protocol, Biotechnology, Clinical Monitoring, Vaccines, Lifesciences, Regulatory Affairs, Clinical Study Design, Clinical Operations, Translational Medicine, Drug Discovery, Neurology, Pharmacokinetics, Neuroscience, Biomarkers, Hematology, Life Sciences
Education
LIU Brooklyn 2002 — 2005
Master of Science, Pharmacology and Toxicology
Guangxi Medical University 1986 — 1999
MD, MS, Anesthesilogy
Amphastar Pharmaceuticals, Inc. September 2014 - Present
Allergan May 2012 - September 2014
Ono Pharma USA July 2011 - April 2012
Eisai Inc August 2008 - August 2011
Organon USA Inc March 2005 - July 2008
Long Island University 2002 - 2005
Skills
Clinical Research, Clinical Development, Pharmacology, Clinical Trials, Oncology, Therapeutic Areas, Pharmaceutical Industry, GCP, Drug Development, Clinical Pharmacology, Medical Writing, Regulatory Submissions, Drug Safety, CRO, Infectious Diseases, Immunology, CTMS, EDC, Cardiology, Medical Affairs, Clinical Data Management, Toxicology, IND, ICH-GCP, Pharmacovigilance, FDA, Protocol, Biotechnology, Clinical Monitoring, Vaccines, Lifesciences, Regulatory Affairs, Clinical Study Design, Clinical Operations, Translational Medicine, Drug Discovery, Neurology, Pharmacokinetics, Neuroscience, Biomarkers, Hematology, Life Sciences
Education
LIU Brooklyn 2002 — 2005
Master of Science, Pharmacology and Toxicology
Guangxi Medical University 1986 — 1999
MD, MS, Anesthesilogy
Sara Leone's Ono Pharma USA Experience October 2011 - February 2013
Job Director Oncology Program / Clinical Project Director. Pharma, Greater NYC/NJ/Phila area
Industry Pharmaceuticals
Experience
PAREXEL January 2013 - Present
Ono Pharma USA October 2011 - February 2013
Pharmaxis February 2008 - November 2011
PRA International 2006 - 2008
PRA International 2004 - 2006
PRA International 2002 - 2004
PharmaNet 2001 - 2002
Wyeth Pharmaceuticals 2000 - 2001
Skills
Clinical Trials, CRO, Oncology, Clinical Research, GCP, Neurology, Pharmaceutical Industry, EDC, Clinical Development, Diabetes, ICH-GCP, Clinical Monitoring, Drug Development, Cardiology, Clinical Data Management, Biotechnology, Clinical, Data Management, Protocol, 21 CFR Part 11, Project Management, Therapeutic Areas, Budgets, EU, Budgeting, Pharmaceuticals, Clinical Trial..., Contract Negotiation, Research, Phase I, Cross-functional Team..., Vendor, FDA, Clinical Operations, Hematology, Validation, CRF design, Patient Recruitment, Clinical Study Design, Oracle Clinical, Global Operations, Trial Management, MedDRA, Phase 2, Pharmacokinetics, Asthma, Dermatology, IRB, IND, Program Transitions...
Education
John Cabot University_Rome, Italy
Saint Joseph's University
B.S.
Saint Joseph's University
MS Coursework
PAREXEL January 2013 - Present
Ono Pharma USA October 2011 - February 2013
Pharmaxis February 2008 - November 2011
PRA International 2006 - 2008
PRA International 2004 - 2006
PRA International 2002 - 2004
PharmaNet 2001 - 2002
Wyeth Pharmaceuticals 2000 - 2001
Skills
Clinical Trials, CRO, Oncology, Clinical Research, GCP, Neurology, Pharmaceutical Industry, EDC, Clinical Development, Diabetes, ICH-GCP, Clinical Monitoring, Drug Development, Cardiology, Clinical Data Management, Biotechnology, Clinical, Data Management, Protocol, 21 CFR Part 11, Project Management, Therapeutic Areas, Budgets, EU, Budgeting, Pharmaceuticals, Clinical Trial..., Contract Negotiation, Research, Phase I, Cross-functional Team..., Vendor, FDA, Clinical Operations, Hematology, Validation, CRF design, Patient Recruitment, Clinical Study Design, Oracle Clinical, Global Operations, Trial Management, MedDRA, Phase 2, Pharmacokinetics, Asthma, Dermatology, IRB, IND, Program Transitions...
Education
John Cabot University_Rome, Italy
Saint Joseph's University
B.S.
Saint Joseph's University
MS Coursework
Jabed Seraj's Ono Pharma USA Experience December 2011 - November 2013
Job Medical Director at Taiho
Industry Pharmaceuticals
Experience
Taiho Oncology Inc., October 2013 - Present
Ono Pharma USA December 2011 - November 2013
Merck April 2006 - December 2011
Johnson & Johnson January 2002 - April 2006
Skills
Clinical Trials, Clinical Development, Oncology, Clinical Research, Clinical Pharmacology, Drug Development, CTMS, Therapeutic Areas, Pharmaceutical Industry, GCP, Biomarkers, Drug Discovery, Pharmacology, Regulatory Submissions, Biotechnology, FDA
Education
Pennsylvania State University College of Medicine 1997 — 1999
Oncology Fellowship
The University of Tokushima, Japan 1992 — 1997
PhD, Medical Science
Dhaka University 1983 — 1989
MBBS, Medical Doctor
Taiho Oncology Inc., October 2013 - Present
Ono Pharma USA December 2011 - November 2013
Merck April 2006 - December 2011
Johnson & Johnson January 2002 - April 2006
Skills
Clinical Trials, Clinical Development, Oncology, Clinical Research, Clinical Pharmacology, Drug Development, CTMS, Therapeutic Areas, Pharmaceutical Industry, GCP, Biomarkers, Drug Discovery, Pharmacology, Regulatory Submissions, Biotechnology, FDA
Education
Pennsylvania State University College of Medicine 1997 — 1999
Oncology Fellowship
The University of Tokushima, Japan 1992 — 1997
PhD, Medical Science
Dhaka University 1983 — 1989
MBBS, Medical Doctor
Jeanne Mendell-Harary's Ono Pharma USA Experience 2005 - 2007
Job Director, Clinical Pharmacology at Daiichi Sankyo
Industry Pharmaceuticals
Experience
Daiichi Sankyo 2007 - Present
Ono Pharma USA 2005 - 2007
Noven Pharmaceuticals 2002 - 2005
Pharmacokinetic Consulting, LLC 1997 - 2002
University of Maryland 1994 - 1997
IVAX 1989 - 1994
Skills
Clinical Pharmacology, Pharmacology, Phase I, PK/PD, Clinical Development, CRO, Clinical Trials, Pharmacodynamics, Drug Development, Informatics, Translational Medicine, Clinical Study Design, Pharmacokinetics, IND, Biomarkers
Education
Massachusetts College of Pharmacy and Health Sciences
BS, Pharmacy
University of Maryland Baltimore
PhD, Pharmaceutical Sciences (pharmacokinetics)
University of Miami
MPH, Epidemiology and Biostatistics
Daiichi Sankyo 2007 - Present
Ono Pharma USA 2005 - 2007
Noven Pharmaceuticals 2002 - 2005
Pharmacokinetic Consulting, LLC 1997 - 2002
University of Maryland 1994 - 1997
IVAX 1989 - 1994
Skills
Clinical Pharmacology, Pharmacology, Phase I, PK/PD, Clinical Development, CRO, Clinical Trials, Pharmacodynamics, Drug Development, Informatics, Translational Medicine, Clinical Study Design, Pharmacokinetics, IND, Biomarkers
Education
Massachusetts College of Pharmacy and Health Sciences
BS, Pharmacy
University of Maryland Baltimore
PhD, Pharmaceutical Sciences (pharmacokinetics)
University of Miami
MPH, Epidemiology and Biostatistics
Madhu Anant's Ono Pharma USA Experience 2000 - 2002
Job Pharmaceutical Consultant with Expertise in Clinical Development, Regulatory Affairs and Drug Safety
Industry Pharmaceuticals
Experience
A.V. Pharmaceutical Consulting September 2011 - Present
Valeant Pharmaceuticals November 2011 - January 2013
Bristol-Myers Squibb 2009 - 2011
Bayer Health Care Pharmaceuticals June 2008 - June 2009
Solvay Pharmaceuticals 2005 - 2008
Aventis, Bristol-Myers Squibb 2002 - 2005
Ono Pharma USA 2000 - 2002
Bracco Diagnostics/Research USA 1994 - 2000
Sterling-Eastman 1990 - 1993
Skills
Clinical Development, Clinical Research, Clinical Trials, Product Launch, Drug Development, Vaccines, Oncology, Regulatory Affairs, Endocrinology, Therapeutic Areas, Pharmaceutical Industry, CRO, FDA, Regulatory Submissions, Biotechnology, Pharmacovigilance, Pharmacology, eCTD, Pharmaceutics, GCP, GMP, Change Control, Protocol, IND, Infectious Diseases, V&V, CAPA, NDA, Validation, GxP, Biologics, CTMS, Sop, Medical Writing, Technology Transfer, GLP, Medical Devices, Medical Affairs, Drug Safety, Immunology, 21 CFR Part 11, Lifesciences, Biopharmaceuticals, Regulatory Requirements, Drug Discovery, CMC, Clinical Pharmacology, Toxicology, Pharmacokinetics, ICH-GCP
Education
Nagpur University
Master of Science, Biochemistry
Rutgers, The State University of New Jersey-New Brunswick
Ph.D., Integrated Health Science
A.V. Pharmaceutical Consulting September 2011 - Present
Valeant Pharmaceuticals November 2011 - January 2013
Bristol-Myers Squibb 2009 - 2011
Bayer Health Care Pharmaceuticals June 2008 - June 2009
Solvay Pharmaceuticals 2005 - 2008
Aventis, Bristol-Myers Squibb 2002 - 2005
Ono Pharma USA 2000 - 2002
Bracco Diagnostics/Research USA 1994 - 2000
Sterling-Eastman 1990 - 1993
Skills
Clinical Development, Clinical Research, Clinical Trials, Product Launch, Drug Development, Vaccines, Oncology, Regulatory Affairs, Endocrinology, Therapeutic Areas, Pharmaceutical Industry, CRO, FDA, Regulatory Submissions, Biotechnology, Pharmacovigilance, Pharmacology, eCTD, Pharmaceutics, GCP, GMP, Change Control, Protocol, IND, Infectious Diseases, V&V, CAPA, NDA, Validation, GxP, Biologics, CTMS, Sop, Medical Writing, Technology Transfer, GLP, Medical Devices, Medical Affairs, Drug Safety, Immunology, 21 CFR Part 11, Lifesciences, Biopharmaceuticals, Regulatory Requirements, Drug Discovery, CMC, Clinical Pharmacology, Toxicology, Pharmacokinetics, ICH-GCP
Education
Nagpur University
Master of Science, Biochemistry
Rutgers, The State University of New Jersey-New Brunswick
Ph.D., Integrated Health Science
Jennifer Yang's Ono Pharma USA Experience April 2010 - January 2011
Job
Industry Biotechnology
Experience
Novo Nordisk Inc. September 2013 - Present
Liquent February 2011 - September 2013
Ono Pharma USA April 2010 - January 2011
Genmab November 2007 - April 2010
Skills
Regulatory Submissions, eCTD, Regulatory Operations, IND, Electronic Document..., NDA, BLA, Document Management, Regulatory Requirements, EDRMS, Sop, Validation, Drug Development, Regulatory Affairs, SOP
Education
New York University 1998 — 2000
MA, Food Management
Taipei Medical University 1993 — 1996
BS, Nutrition and Health
Novo Nordisk Inc. September 2013 - Present
Liquent February 2011 - September 2013
Ono Pharma USA April 2010 - January 2011
Genmab November 2007 - April 2010
Skills
Regulatory Submissions, eCTD, Regulatory Operations, IND, Electronic Document..., NDA, BLA, Document Management, Regulatory Requirements, EDRMS, Sop, Validation, Drug Development, Regulatory Affairs, SOP
Education
New York University 1998 — 2000
MA, Food Management
Taipei Medical University 1993 — 1996
BS, Nutrition and Health
Emily Clark, MPA, CCRP's Ono Pharma USA Experience January 2007 - December 2007
Job Senior Regional Site Manager at Forest Laboratories
Industry Research
Experience
Forest Laboratories December 2013 - Present
Forest Laboratories (contracted through Precept Life Sciences) July 2012 - December 2013
Pfizer (contract position with various companies) March 2011 - July 2012
Pfizer (contracted with Kforce) December 2007 - March 2011
Ono Pharma USA January 2007 - December 2007
Skills
Clinical Trials, CTMS, Clinical Monitoring, ICH-GCP, Pharmaceutical Industry, GCP, EDC, Oncology, CRO, Therapeutic Areas, Clinical Research
Education
Louisiana State University 2000 — 2002
M.P.A, Public Administration
Louisiana State University 1993 — 1997
B.S, Microbiology
Forest Laboratories December 2013 - Present
Forest Laboratories (contracted through Precept Life Sciences) July 2012 - December 2013
Pfizer (contract position with various companies) March 2011 - July 2012
Pfizer (contracted with Kforce) December 2007 - March 2011
Ono Pharma USA January 2007 - December 2007
Skills
Clinical Trials, CTMS, Clinical Monitoring, ICH-GCP, Pharmaceutical Industry, GCP, EDC, Oncology, CRO, Therapeutic Areas, Clinical Research
Education
Louisiana State University 2000 — 2002
M.P.A, Public Administration
Louisiana State University 1993 — 1997
B.S, Microbiology
Shinji Shinoda's Ono Pharma USA Experience June 2010 - Present
Job Senior Manager at Ono Pharma USA
Industry Pharmaceuticals
Experience
Ono Pharma USA June 2010 - Present
Ono Pharma USA June 2010 - Present
Skills
Clinical Development, Pharmaceutical Industry, Oncology, Biotechnology, CRO, Clinical Trials, Pharmacology, Drug Discovery, Vaccines, Biopharmaceuticals, Commercialization, Licensing, FDA, Immunology, Lifesciences, Infectious Diseases, GLP, Drug Development, Medical Devices
Education
大阪大学 / Osaka University
Master's degree
Ono Pharma USA June 2010 - Present
Ono Pharma USA June 2010 - Present
Skills
Clinical Development, Pharmaceutical Industry, Oncology, Biotechnology, CRO, Clinical Trials, Pharmacology, Drug Discovery, Vaccines, Biopharmaceuticals, Commercialization, Licensing, FDA, Immunology, Lifesciences, Infectious Diseases, GLP, Drug Development, Medical Devices
Education
大阪大学 / Osaka University
Master's degree
Thuy Anh Le's Ono Pharma USA Experience May 2008 - Present
Job Associate Director of Medical Communications at Ono Pharma USA
Industry Pharmaceuticals
Experience
The Cloud Institute For Sustainability Education 2011 - Present
Ono Pharma USA May 2008 - Present
Skills
Clinical Trials, Biotechnology, Drug Development, Clinical Development, FDA, Medical Writing, Protocol, Pharmaceutics, Cross-functional Team..., Oncology, CTMS, Pharmaceutical Industry, 21 CFR Part 11, GCP, IND, Therapeutic Areas, Pharmacology, Regulatory Submissions
Education
Fairleigh Dickinson University
Master of Business Administration (M.B.A.), Pharmaceutical Sciences
Rutgers University
Bachelor's degree, Biochemistry
The Cloud Institute For Sustainability Education 2011 - Present
Ono Pharma USA May 2008 - Present
Skills
Clinical Trials, Biotechnology, Drug Development, Clinical Development, FDA, Medical Writing, Protocol, Pharmaceutics, Cross-functional Team..., Oncology, CTMS, Pharmaceutical Industry, 21 CFR Part 11, GCP, IND, Therapeutic Areas, Pharmacology, Regulatory Submissions
Education
Fairleigh Dickinson University
Master of Business Administration (M.B.A.), Pharmaceutical Sciences
Rutgers University
Bachelor's degree, Biochemistry
Daisuke Nakayama's Ono Pharma USA Experience July 2013 - Present
Job Director at Ono Pharma USA
Industry Pharmaceuticals
Experience
Ono Pharma USA July 2013 - Present
Ono Pharma USA July 2010 - July 2013
Skills
Lifesciences, CRO, Oncology, Drug Development, Clinical Development, Biotechnology, Pharmaceutical Industry, Life Sciences, Technology Transfer, Regulatory Submissions, GCP, CTMS
Education
熊本大学 / Kumamoto University 2001 — 2006
Doctor of Philosophy (Ph.D.), Biochemistry
Ono Pharma USA July 2013 - Present
Ono Pharma USA July 2010 - July 2013
Skills
Lifesciences, CRO, Oncology, Drug Development, Clinical Development, Biotechnology, Pharmaceutical Industry, Life Sciences, Technology Transfer, Regulatory Submissions, GCP, CTMS
Education
熊本大学 / Kumamoto University 2001 — 2006
Doctor of Philosophy (Ph.D.), Biochemistry
Shinji Eguchi's Ono Pharma USA Experience January 2013 - Present
Job Manager at Ono Pharma USA
Industry Pharmaceuticals
Experience
Ono Pharma USA January 2013 - Present
ONO Pharmaceutical Company, LTD April 2004 - December 2012
Education
Okayama University 1998 — 2007
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Ono Pharma USA January 2013 - Present
ONO Pharmaceutical Company, LTD April 2004 - December 2012
Education
Okayama University 1998 — 2007
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences