Cato Research
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Cato Research Employees
Strategic Drug Development Services, LLC 2014 - Present
Cardinal Health , Specialty Pharmaceutical Distribution 2005 - 2014
Kowa Research 2003 - 2005
PAREXEL 2000 - 2003
Nobex Corporation 1999 - 2000
Cato Research 1989 - 1999
Skills
Strategic Communications, Product Development, Global Drug Development, Regulatory Submissions, Clinical Research, FDA, Regulatory Requirements, Medical Writing, Regulatory Affairs, Healthcare, Patient Safety, Risk Analysis, Healthcare Consulting, Healthcare Industry, Marketing Strategy, Licensing
Education
State University of New York College at Potsdam
Bachelor of Arts (BA), Biology/Psychology
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Neurobiology
Quintiles August 2014 - Present
PAREXEL November 2012 - August 2014
PAREXEL May 2011 - November 2012
INC Research October 2010 - May 2011
INC Research December 2009 - October 2010
INC Research August 2009 - December 2009
Duke University Medical Center February 2009 - July 2009
North Carolina State University September 2008 - December 2008
North Carolina State University August 2008 - December 2008
Cato Research May 2008 - October 2008
Skills
CRO, Clinical Research, Clinical Trials, GCP, Human Resources, ICH-GCP, IRB, Informed Consent, Interviews, Lifesciences, Oncology, Pharmaceutical Industry, Protocol, Regulatory Requirements, Research, Start-ups, Clinical Monitoring, Clinical Operations, Sop
Education
North Carolina State University 2005 — 2009
Psychology
Argos Therapeutics August 2007 - Present
PPD June 2003 - September 2007
Cato Research June 1996 - June 2003
Abbott Laboratories January 1979 - January 1996
Skills
Clinical Trials, Clinical Research, Infectious Diseases, Immunology, Biotechnology, Oncology, Clinical Development, CTMS, CRO, GCP, Sop, Lifesciences, Drug Development, FDA, GLP
Education
Libertyville HS
Biology
Purdue University
BS, Biology
Cato Research June 2013 - Present
Bravo Brio Restaurant Group November 2008 - July 2014
La Piazza Italian Restaurant January 2008 - October 2008
Ruby Tuesday August 2006 - October 2008
United States Air Force September 2000 - September 2005
Education
North Carolina State University 2009 — 2013
Bachelor of Science (BS), Biochemistry
Wake Technical Community College 2005 — 2008
Associate of Science (AS), Science
BioMarin Pharmaceutical Inc October 2008 - Present
Cato Research April 2004 - October 2008
Schering Plough Animal Health 1993 - 2004
Skills
IND, Regulatory Submissions, Drug Development, Regulatory Affairs, Clinical Development, eCTD, FDA, GCP, Clinical Trials, CRO, Pharmacovigilance, Medical Writing, Biopharmaceuticals, Life Sciences, Biotechnology, NDA, Pharmaceutical Industry
Education
Texas A&M University 2000 — 2003
Ph.D., Molecular Virology
Walla Walla University
BS, MS, Biology
Novella Clinical, Inc. August 2000 - Present
ClinTrials Research August 1998 - August 2000
Cato Research May 1996 - May 1998
Skills
Project Finance, Budgets, CRO, Clinical Trials, Cost Accounting, Financial Analysis, Financial Reporting, Forecasting, Microsoft Excel, Pharmaceutical Industry, Process Improvement, Variance Analysis
Education
North Carolina State University 1991 — 1995
BA, Communication
Club Z! In-Home Tutoring Services May 2014 - Present
Cato Research October 2012 - Present
Nemours 2011 - 2011
Skills
Clinical Research, Microsoft Office, Time Management, HIPAA, EMR, Medical Terminology, Medical Records, Microsoft Excel, Regulatory Submissions, Regulatory Affairs, Data Management, Project Coordination, Organization, Gantt Project
Education
University of Alabama 2008 — 2012
Bachelor of Science (B.S.), Mathematics
University of Alabama 2008 — 2012
Bachelor of Science (B.S.), Mathematics
Trevena, Inc June 2014 - Present
IKARIA, Inc. October 2012 - January 2014
Janssen Services, LLC August 2006 - September 2012
University of North Carolina December 1996 - August 2006
Cato Research 1995 - 1996
Skills
Clinical Development, Clinical Trials, Medical Affairs, Immunology, Clinical Research, Protocol, Gastroenterology, Hematology, Regulatory Affairs, Sop, Drug Development, Cell, Medical Writing, Biotechnology, Pharmacology, Dermatology, Translational Research, FDA, Medical Research, Pharmaceutical Industry, Vascular Biology, KOL development, Protocol Design, Pediatrics, Orphan Drugs, GCP, Clinical Trial Analysis, Clinical Protocols, Cardiovascular..., Respiratory Disease, Biomarkers, Medical Information
Education
Holly Hill-Roberts High School
High School
University of North Carolina
Bachelor of Arts, Biology
North Carolina Central University
Master of Science, Biology
University of North Carolina
Doctor of Philosophy, Pharmacology
Covance Lead CRACovanceJanuary 2012 - November 2014
PharmaNet Development Group, Inc. 2009 - 2012
ResearchPoint March 2007 - March 2009
PAREXEL January 2005 - March 2007
King Pharmaceuticals June 2002 - January 2005
Cato Research March 2000 - May 2002
Peace Corps September 1998 - December 1999
Skills
CRO, CTMS, Clinical Research, Clinical Trials, GCP, Pharmaceutical Industry, Infectious Diseases, Clinical Development, Clinical Monitoring, EDC
Education
Tulane University 1997 — 1998
MSPH, Parasitology
University of North Carolina at Chapel Hill 1993 — 1997
BS, Biology, Chemistry
Cato Research July 2012 - Present
University of North Carolina at Chapel Hill November 2005 - June 2012
University of California, San Francisco August 1999 - December 2005
UC San Diego June 1998 - July 1999
Skills
Molecular Biology, Genetics, PCR, Developmental Biology, Genomics, Microscopy, qPCR, Molecular Cloning, RT-PCR, In Vitro, Cell Culture, Transfection, Fluorescence Microscopy, Confocal Microscopy, Life Sciences, Cell Biology, Research, eCTD, Regulatory Affairs, Medical Writing, Protein Chemistry, Drug Development, Clinical Development, Cell, FDA, Animal Models, Immunology, Biochemistry, Lifesciences, Clinical Research, Oncology, In Vivo, CTMS, Clinical Trials
Education
University of California, San Francisco 1999 — 2006
Ph.D., Biomedical Sciences
University of California, San Diego 1994 — 1998
B.S., Molecular Biology
FHI 360 June 2007 - Present
Cato Research July 2005 - June 2007
Skills
Research Management, Technical Writing, Editing, Clinical Research
Education
University of Washington 1999 — 2005
Doctor of Philosophy (PhD), Physiology and Biophysics
University of Washington 1997 — 1999
Master of Science (MS), Applied Mathematics
Spelman College 1993 — 1997
Bachelor of Arts (B.A.), Mathematics
Catalent Pharma Solutions May 2014 - Present
GSK May 2012 - May 2014
GSK March 2009 - May 2012
Cato Research May 2005 - January 2006
Skills
HPLC, Drug Discovery, GMP, Biotechnology, FDA, Dissolution, R&D, LIMS, Chromatography, Clinical Trials, Leadership, Drug Development, Laboratory, Next Generation..., Pharmaceutical Industry, Empower, Chemstation, Analytical Chemistry, Content Uniformity, Delivered Dose, USP, Validation
Education
North Carolina State University 2006 — 2008
BS, Microbiology, Genetics
North Carolina State University 2000 — 2004
BA, Chemistry
Millbrook High School 1996 — 2000
High School Diploma, College Prep
PRA Health Sciences October 2012 - Present
INC Research January 2007 - October 2012
Constella Group July 2006 - October 2006
PPD April 2004 - November 2005
Cato Research February 2001 - February 2004
Araccel January 2000 - February 2001
PAREXEL August 1998 - December 1999
InSite Clinical Trials August 1997 - August 1998
InSite Clinical Trials January 1997 - August 1997
Duke University Medical Center-CALGB Cancer Center January 1996 - January 1997
Skills
CRO, Clinical Trials, Oncology, Clinical Research, Pharmaceutical Industry, Regulatory Affairs, Clinical Monitoring, CTMS, ICH-GCP, EDC, GCP, Therapeutic Areas, Clinical Development, Data Management, Clinical Operations, FDA, Protocol
Education
North Carolina State University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
SynteractHCR March 2014 - Present
Pfizer Inc 2010 - 2012
PRA International 2010 - 2010
PRA International 2007 - 2010
Cato Research 2004 - 2007
Cato Research 2003 - 2004
The Scripps Research Institute 2002 - 2003
The University of Chicago 2000 - 2002
Skills
CTMS, EDC, CRO, Pharmaceutical Industry, Trial Management, Clinical Research, Clinical Monitoring, Clinical Study Design, ICFs, Investigator Brochures, Clinical Trials, CRF design, Project Management, MS Project, Regulatory Affairs, International, Investigator Meetings, Protocol Design, Vendor Management, Quality Management, Budget, Monitoring report review, Subject Recruitment, Subject retention, Clinical Operations, Microsoft Office, Compliance, GCP, Regulatory Requirements, Therapeutic Areas, Protocol, Regulatory Submissions, ICH guidelines, ICH-GCP, Oracle Clinical, Drug Development, Sop, Medical Writing, IRB, Rheumatology, Neurology, IND, Patient Recruitment, Budgets, Clinical Development, Clinical Data Management
Education
San Diego State University-California State University
MS, Regulatory Affairs
University of California, San Diego 2003 — 2004
Professional Certificate, Clinical Trials Design and Management
Indiana University 1994 — 1999
BS, BA, Biology, Spanish
Cato Research June 2010 - Present
Cato Research March 2005 - June 2010
Maxim Pharmaceuticals September 1997 - February 2005
Accumetrics December 1996 - September 1997
Pacific Pharmaceuticals March 1995 - December 1996
Pacific Biotech, Inc. (Eli Lilly) November 1990 - March 1995
Hybritech, Inc. June 1980 - November 1990
Skills
Biotechnology, Medical Devices, Drug Development, Oncology, Clinical Trials, FDA, Pharmaceutical Industry, Regulatory Affairs, IND, GLP, Validation, Clinical Development, Infectious Diseases, Lifesciences, GMP, Biopharmaceuticals, Sop, Life Sciences, Chemistry, Formulation, Clinical Research, CRO, Pharmaceutics, Strategy, Technology Transfer, Regulatory Submissions
Education
University of Phoenix 1990 — 1993
MBA, Business
University of California, San Diego 1977 — 1979
BA, Biology and Biochemistry
H. Lundbeck A/S January 2013 - Present
Lundbeck May 2010 - December 2012
Cato Research February 2002 - May 2010
Skills
Clinical Operations, CTMS, Oncology, Clinical Research, Therapeutic Areas, GCP, Clinical Trials, CRO, Molecular Biology, Clinical Development, Psychiatry, Neurology, Clinical Study Design, Pharmaceutical Industry
Education
Université de Montréal 1999 — 2002
Ph.D., Biomedical Sciences
Université Laval 1997 — 1999
M.Sc., Physiology-Endocrinology
Université Laval 1994 — 1997
B.Sc., Biochemistry
Cato Research August 2009 - Present
Cato Research, Ltd. July 2007 - August 2009
Cato Research, Ltd. June 2007 - June 2008
Skills
Clinical Trials, CRO, Life Sciences, GCP
Education
North Carolina State University 2004 — 2008
Bachelor of Science (BS), Biological Sciences
GlobalSubmit May 2015 - Present
Bioventus February 2013 - April 2015
Cato Research January 2010 - February 2013
Cato Research March 2008 - January 2010
Cato Research October 2006 - March 2008
US Investigations August 2004 - July 2006
A Cleaner World April 2003 - July 2004
Skills
Regulatory Affairs, IND, FDA, eCTD, NDA, Project Management, Combination Products, Strategy, Document Preparation, Clinical Trials, Validation, Training, GCP, Pharmaceutical Industry, Sop, Drug Development, Biotechnology, SOP, Regulatory Submissions, CRO, Medical Devices
Education
North Carolina State University 1995 — 2001
BS
Cato Research November 2013 - Present
Quintiles January 2013 - November 2013
ethica Clinical Research Inc. 2007 - May 2010
ethica Clinical Research Inc. October 2005 - September 2007
Skills
Clinical Data Management, Clinical Research, GCP, SAS programming, CDISC, Clinical Trials, EDC, Oracle Clinical, Interpersonal Skill, CRO, CRF design, Biostatistics, Pharmaceutical Industry, Clinical Development, Secteur pharmaceutique, Bonnes pratiques..., Développement clinique
Education
2002 — 2003
Maitrise, Statistique
1995 — 1999
Baccalauréat, Statistique
MacroGenics December 2009 - Present
MedImmune March 2007 - December 2009
MedImmune July 2001 - March 2007
Cato Research December 1999 - June 2001
INTRACEL Corporation May 1998 - December 1999
Education
Northern Virginia Community College
A.A.S., Animal Science
Radius Health, Inc. November 2014 - Present
Sanofi January 2011 - November 2014
Novartis April 2009 - December 2010
Cato Research 2008 - 2009
National Health Service 2007 - 2008
University of Manchester 2004 - 2007
AstraZeneca 2001 - 2004
Skills
Oncology, Clinical Development, Clinical Trials, Clinical Research, Translational Medicine, Drug Development, GCP, ICH-GCP
Education
Newcastle University 1998 — 2001
PhD
The University of Edinburgh 1994 — 1998
BSc
Cato Research September 2013 - Present
Biotechnology Industry August 2012 - September 2013
Centre for Integrated Preclinical Drug Development/TetraQ, University of Queensland June 2009 - August 2012
Alchemia Limited, Queensland, Australia 2000 - 2008
Ribi ImmunoChem Research, Montana, USA 1983 - 1999
Beckman Instruments 1976 - 1982
Skills
Commercialization, Intellectual Property, Strategy, Product Marketing, Venture Capital, Clinical Trials, Genetics, Market Analysis, Infectious Diseases, Start-ups, Oncology, Business Development, Cross-functional Team..., Bioinformatics, Business Strategy, Biopharmaceuticals, Vaccines, Cell Biology, Analysis, Regulatory Affairs, Microbiology
Education
University of California, Berkeley 1970 — 1975
BA, Bacteriology
Self January 2014 - Present
SunTrust Mortgage November 2011 - December 2013
Experis July 2011 - November 2011
Insmed, Inc. August 2005 - December 2010
Self February 2003 - August 2005
MedImmune November 1999 - February 2003
Cato Research December 1996 - November 1999
Boehringer Mannheim September 1991 - December 1996
Skills
Clinical Data Management, EDC, Oracle Clinical, Oracle Inform, SDLC, Databases, Biotechnology, CRF design, Clinical Study..., Data Validation, Test Scripts, SAE Reconciliation, ICH-GCP, CDISC, Vendor Relationship..., Client Rapport, Client Presentation, Software Documentation, Technical Documentation, Technical Writing, Policies & Procedures..., Project Tracking, Immunology, Cardiology, Respiratory Therapy, Gastrointestinal..., Medical Devices, Medical Terminology, Training, MS Office Suite, Microsoft Office, Data Management, Pharmaceutical Industry, Clinical Trials
Education
University of Phoenix
Bachelor of Science
Montgomery College 1997 — 2001
Associates of Applied Sciences
Montgomery College 1991 — 1997
Certificate
inVentiv Health Clinical November 2012 - Present
Cato Research March 2010 - November 2012
PharmaNet Development Group, Inc. June 2008 - February 2010
Quintiles May 2005 - June 2008
MedFocus March 2004 - May 2005
MedFocus September 2002 - March 2004
Skills
CRO, Biostatistics, Clinical Trials, CDISC, Clinical Development, EDC, Clinical Data Management, GCP, Clinical Research, Clinical Study Design, Oncology, SAS, SAS programming
Education
University of California, Los Angeles - Fielding School of Public Health 2000 — 2002
MS, Biostatistics
University of California, Los Angeles 1998 — 2000
MS, Human Genetics
Peking University 1992 — 1997
BS, Medicine
Law Offices of Marc Grossman October 2013 - March 2014
Law Offices of William W. Green & Associates February 2013 - May 2013
Superior Court of California, County of San Bernardino May 2012 - August 2012
Cato Research October 2007 - July 2010
Meeting Sites Pro January 2006 - June 2007
Skills
Microsoft Office, Training, Event Planning, Customer Service, Event Management, Budgets, Program Management, Sales, Legal Research, Westlaw, Legal Writing, Personal Injury, Family Law, Lexis, Mediation, Policy, Courts, Civil Litigation, Contract Negotiation
Education
University of La Verne 2010 — 2013
JD/MBA, Emphasis in Leadership and Management, 3.96 GPA (MBA)
San Diego State University-California State University 2002 — 2007
B.S., Business Management
Canyon High
Atlantic Research Group November 2014 - Present
Atlantic Research Group October 2011 - November 2014
Cato Research June 2010 - October 2011
Cato Research May 2010 - September 2011
Cato Research 2009 - September 2011
Cato Research 2007 - 2009
Skills
Clinical Trials, Marketing, GCP, CRO, Project Management, Clinical Research, CTMS, Pharmaceutical Industry, Biotechnology
Education
University of Arizona
Cato Research April 2013 - Present
PharmaNet/i3 January 2010 - January 2013
PharmaNet/i3 July 2006 - January 2010
PharmaNet Development Group, Inc. March 2000 - June 2006
Quintiles Transnational January 1995 - March 2000
Skills
Data Management, EDC, Sop, CTMS, Databases, Clinical Trials, Software Development, Clinical Data Management, 21 CFR Part 11, SQL, Enterprise Architecture, Testing, System Architecture, Java, GCP, Clinical Research, Clinical Development, Pharmaceutical Industry, Oracle, CRO, CDISC, Crystal Reports, Project Management, JavaScript, SDLC, Integration, Cross-functional Team..., Protocol, Web Applications, Computer System..., Quality Assurance, SOP, SharePoint, Oracle Clinical
Education
North Carolina State University
MS
North Carolina Central University
BSc
Benson Scientific Consulting July 2014 - Present
Jazz Pharmaceuticals April 2008 - July 2014
Amgen November 2004 - March 2008
Watson Pharmaceuticals September 2001 - August 2004
Cato Research April 2000 - August 2001
Skills
Clinical Development, Oncology, Biotechnology, Clinical Trials, Pharmaceutical Industry, Drug Development, FDA, CRO, Lifesciences, GCP, Clinical Research, Biopharmaceuticals, Immunology, Endocrinology, Protocol, Clinical Study Design, Pharmacology, IND, Medical Affairs, Therapeutic Areas
Education
University of Utah School of Medicine 1995 — 2000
Post-doc, Genetics, cellular and molecular biology
The University of Kansas 1990 — 1995
PhD, Pharmacology & Toxicology
University of Oklahoma 1978 — 1982
B.S., Microbiology
WHDH-TV September 2015 - Present
WNCN July 2015 - Present
Carolina Woman, Inc. July 2015 - Present
Her Campus Media January 2015 - Present
Greentarget Global Group January 2015 - June 2015
Cato Research June 2013 - August 2013
Triangle Sportsplex September 2012 - August 2013
Skills
News Writing, Breaking News, Online News, Newspapers, Television News, Social Media, Facebook, Editing, Political Science, Spanish, Teaching, Sports, Research, Coaching, Event Planning, Public Speaking, Fundraising, Public Relations, Marketing, Advertising, Video Editing, Photography
Education
Northeastern University 2013 — 2017
Bachelor's Degree, Journalism and Political Science, Sophomore
Chapel Hill High School 2009 — 2013
HS Diploma
Premier Research 2014 - Present
Cato Research 2010 - 2014
Cato Research 2006 - 2010
Cato Research 2005 - 2007
LabCorp 2004 - 2005
CompUSA 2000 - 2005
LabCorp 2003 - 2004
Rex Healthcare 2002 - 2003
Skills
Clinical Trials, GCP, CTMS, CRO, Clinical Research, Clinical Monitoring, EDC, FDA, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Development, Lifesciences, Sop, Infectious Diseases, Protocol, Clinical Study Design, ICH-GCP, Regulatory Submissions, SOP
Education
North Carolina State University 1998 — 2002
B.S., Biological Sciences
vTv Therapeutics LLC May 2015 - Present
Cato Research June 2013 - May 2015
Cato Research 2012 - May 2015
Cato Research 2007 - 2013
Cato Research 2007 - 2011
Cato Research 2005 - 2007
Cato Research 2003 - 2005
Cato Research 2002 - 2003
Skills
Drug Development, Oncology, Medical Writing, CTMS, Biologics, Clinical Study Design, Regulatory Affairs, IND, CRO, Clinical Development, Clinical Trials, Pharmaceutical Industry, Immunology, FDA, GCP, Vaccines, Gastroenterology, eCTD, NDA
Education
Northwestern University 1996 — 2001
Ph.D., Immunnology, Neuroscience
The Johns Hopkins University 1992 — 1996
B.A., Biology, Psychology
BioMarin Pharmaceutical Inc. September 2006 - Present
Dey, L.P. March 2000 - August 2006
Cato Research 1991 - 2000
Skills
Regulatory Affairs, Pharmaceutical Industry, FDA, Document Management, Biotechnology, Regulatory Submissions, Lifesciences, Sop, Regulatory Requirements, Biopharmaceuticals, GxP, Computer System..., Change Control, CRO, Medical Devices, Drug Development, Clinical Development, Pharmacovigilance, V&V, Life Sciences, Management, Cross-functional Team..., SOP, Clinical Trials
Education
Saint Leo University 2002 — 2005
BA
Cato Research September 2014 - Present
42nd Street Oyster Bar February 2012 - Present
Globe Kids and gals 2006 - 2010
Education
North Carolina State University 2008 — 2014
Bachelor's Degree, Biology/Biological Sciences, General
VistaGen Therapeutics, Inc. August 2009 - Present
Armour Therapeutics Inc. January 2011 - Present
Cato BioVentures February 2001 - August 2009
Cato Research February 2001 - August 2009
Echo Therapeutics September 2007 - June 2009
Start-up Law November 2000 - February 2001
SciClone Pharmaceuticals November 1993 - November 2000
Morrison & Foerster LLP May 1991 - November 1993
Skills
Biotechnology, Clinical Development, Clinical Trials, Drug Development, Clinical Research, Assay Development, Toxicology, Neurology, Medicinal Chemistry, Pharmaceutics, Lifesciences, Licensing, Mergers & Acquisitions, Corporate Governance, Intellectual Property, Venture Capital, Pain Management, Pharmaceutical Industry, Laboratory, Due Diligence, Medical Devices, Technology Transfer, Life Sciences
Education
University of Maryland School of Law 1988 — 1991
Juris Doctor, Law
University of California, Berkeley 1982 — 1985
BA with Honors, Political Science
UCB May 2013 - Present
UCB Pharma January 2012 - May 2013
PharmaNet/i3 August 2010 - December 2011
Cato Research August 2007 - August 2010
Meredith College August 2006 - May 2007
Winston-Salem State University August 2005 - May 2006
Education
Meredith College
B.S., molecular biology and chemistry
Wake Forest University School of Medicine
Ph.D., Molecular Medicine
OBrien CQA, LLC January 2013 - Present
LifeSci Compliance, LLC July 2012 - December 2012
Falcon Consulting Group, LLC January 2011 - June 2012
Falcon Consulting Group LLC April 2009 - January 2011
Falcon Consulting Group, LLC September 2007 - April 2009
Cato Research May 2007 - August 2007
Cato Research August 2003 - May 2007
Cato Research February 1998 - August 2003
Skills
GCP, Clinical Trials, CRO, 21 CFR Part 11, Pharmaceutical Industry, Sop, Clinical Research, Clinical Development, FDA, CTMS, Validation, Oncology, Biotechnology, IND, Medical Writing, EDC, CAPA, Quality Assurance, Quality Control, Biopharmaceuticals, Quality Auditing, SOP
Education
North Carolina State University 1994 — 1998
PhD, Immunology
North Carolina State University 1991 — 1994
Master of Science (M.S.), Biological Engineering
Mississippi State University 1985 — 1989
BS, Biological Engineering
ICON plc February 2014 - Present
Cato Research November 2010 - January 2014
BrainCells, Inc. April 2008 - August 2010
Therapeutics Inc 2005 - 2007
DermTech 2002 - 2004
UC San Diego 1999 - 2002
Salk Institute for Biological Studies 1997 - 1999
San Diego Zoo Global 1991 - 1997
Skills
Clinical Trials, Regulatory Submissions, CRO, Clinical Development, GCP, Clinical Research, Clinical Monitoring, Biotechnology, ICH-GCP, IRB, EDC
Education
San Diego State University-California State University
Bachelor's degree, Pre-Medicine/Pre-Medical Studies
MetLife July 2015 - Present
MetLife October 2014 - July 2015
Randstad Technology - Client: UNC Health Care Systems (UNC, Rex, Johnston, High Point, etc) November 2011 - August 2014
Blue Cross Blue Shield May 2008 - November 2011
Nations Home Funding 2007 - 2007
Cato Research February 2002 - August 2006
Nortel 1996 - 2001
Nortel 1988 - 1996
Skills
Software Documentation, Cross-functional Team..., Project Management, Business Process, Process Improvement, Training, Business Requirements, Requirements Analysis, Human Resources, Telecommunications, Business Analysis, Quality Assurance, Leadership, Software Project..., Budgets, Business Process..., Visio
Education
North Carolina Wesleyan College
BS, Computer Information Systems
Array BioPharma October 2012 - Present
Array BioPharma May 2010 - October 2012
Cato Research October 2004 - May 2010
Skills
Clinical Trials, Oncology, Clinical Development, CRO, Clinical Monitoring, GCP, Medical Writing, Drug Development, Clinical Research, EDC, Biotechnology, Therapeutic Areas, Phase I, Pharmaceutical Industry, Lifesciences, Translational Medicine, IND, FDA
Education
University of North Carolina at Chapel Hill School of Medicine 1999 — 2004
Ph.D., Cellular and Molecular Pathology
Sweet Briar College 1995 — 1999
B.S., Biochemistry and Molecular Biology
Monroe High School
NuVasive May 2011 - Present
Cato Research January 2011 - April 2011
University of California, San Diego 2004 - 2010
Tissue Engineering and Regenerative Medicine International Society, North America December 2007 - December 2008
Johns Hopkins University May 2003 - August 2003
University of California, San Francisco June 2002 - April 2003
Skills
Histology, Tissue Culture, Biomaterials, Assay Development, Tissue Engineering, Cell Culture, Molecular Biology, Biomechanics, Medical Devices
Education
University of California, San Diego 2004 — 2010
PhD, Bioengineering
University of California, Berkeley 2000 — 2004
BS, Bioengineering
Emergent BioSolutions October 2013 - Present
DynPort Vaccine Company LLC, A CSC Company October 2007 - September 2013
MedImmune January 2005 - October 2007
Cato Research 1995 - 2003
Skills
Clinical Trials, CRO, CTMS, GCP, Vaccines, EDC, Oncology, Clinical Development, Clinical Monitoring, FDA, Regulatory Submissions, Biotechnology, Data Management, Infectious Diseases, Clinical Data Management, Therapeutic Areas, Clinical Research, ICH-GCP, Sop, Protocol, IND, Clinical Operations
Education
State University of New York College at Brockport 1980 — 1983
Archbishop Walsh 1975 — 1979
University of Maryland University College
St. Elizabeth's Medical Center February 2014 - Present
St. Elizabeth's Medical Center July 2013 - February 2014
Cato Research May 2010 - 2014
Kate Lembck Orthodontics 2008 - 2010
Skills
Nursing, Clinical Research, Healthcare, Nurse Practitioners, Family Medicine, Medical-Surgical, Patient Advocacy, Patient Safety, Patient Education, Quality Patient Care
Education
Regis College 2012 — 2015
Master’s Degree, Family Nurse Practitioner
Ursinus College 2006 — 2010
B.S., Biology, Spanish, Biostatistics
Cato Research January 2015 - Present
Cato Research January 2014 - January 2015
North Carolina State University April 2013 - July 2013
West Virginia University October 2009 - January 2013
Bureau of Economic Analysis March 2008 - August 2009
JHT, Inc. August 2005 - March 2008
Skills
Data Mining, Public Speaking, Statistics, SAS, Data Analysis, Time Series Analysis, Statistical Modeling, R, Biostatistics, Predictive Modeling, Economics, SAS programming, Logistic Regression, Machine Learning, Analysis
Education
North Carolina State University 2002 — 2005
Master's degree, Statistics
Concord College 1998 — 2001
Bachelor of Science (BS), Mathematics
INC Research July 2009 - Present
Cato Research September 2005 - July 2009
Cato Research February 2004 - September 2005
Skills
Clinical Monitoring, ICH-GCP, EDC, CRO, IWRS/IVRS, Infectious Diseases, Oracle Clinical, Clinical Trials, Therapeutic Areas, Sop, Clinical Research, Oncology, Diabetes, FDA, GCP, CTMS, Vaccines, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Clinical Data Management, Drug Development, Clinical Operations
Education
Université Laval 2001 — 2003
M.B.A., Pharmaceutical Management
Université Laval 1998 — 2001
B.Sc., Microbiology
Ecole Secondaire Soulanges 1990 — 1995
SGS LSS US January 2010 - Present
Cato Research 1999 - 2002
Education
North Carolina State University 1995 — 1999
North Carolina State University - College of Management 1995 — 1999
BS, Biochemistry
PPD November 2014 - Present
PharmaNet/i3 May 2012 - November 2014
Symbiance Inc. January 2011 - May 2012
PPD November 2009 - December 2010
Cato Research August 2009 - November 2009
Symbiance Inc. May 2006 - August 2009
Skills
CDISC, Biostatistics, Clinical Trials, SAS, SAS programming, SDTM, Clinical Study Design, Survival Analysis, Clinical Research, Oncology, Statistical Modeling, R, Statistical Consulting, GCP, EDC, CRO, Statistical Programming, Statistics, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Clinical Development, Data Management, Regulatory Submissions, Infectious Diseases, Multivariate Analysis, SAS Programming
Education
Rutgers University-New Brunswick 2004 — 2006
Master, Statistics
Land of the Waterfalls September 2013 - Present
Mead Johnson & Company 2003 - September 2013
Mead Johnson Nutrition 2003 - January 2011
Mead Johnson Nutrition 2003 - January 2011
CATO November 1997 - August 2003
Cato Research 1997 - 2003
Clintec Nutrition Company 1986 - 1996
Baxter Healthcare November 1976 - August 1986
Skills
Infant Formula..., Clinical Nutrition, Drug Development, Supplements, Pediatrics, Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, FDA, Clinical Development, Oncology, Clinical Research, Biotechnology, Lifesciences, GCP, Babies, Regulations, Quality System, Pharmaceutics, Ingredients, Regulatory Requirements, GMP, Science, Regulatory Submissions, Nutrition, Sop, R&D, Commercialization, GLP, Validation, Technology Transfer, Life Sciences, SOP
Education
University of Tennessee-Health Science Center College of Medicine 1966 — 1974
PhD, Medicine
The University of Memphis 1968 — 1971
MS, Cellular Biology
University of Tennessee-Knoxville 1964 — 1966
BS, Biology, Chemistry
Rhodes College 1962 — 1964
Biology, Music
Bartlett High School 1957 — 1962
High School Diploma, Biology/Biological Sciences, General
Array BioPharma November 2013 - Present
Quintiles May 2013 - November 2013
Array BioPharma November 2011 - May 2013
Array BioPharma May 2009 - October 2011
Abraxis BioScience April 2006 - March 2009
Cato Research 2003 - 2006
Skills
Oncology, Clinical Trials, CTMS, GCP, Clinical Monitoring, Multiple Myeloma, Clinical Development, Clinical Research, Drug Development, FDA, Protocol, IND, Sop, CRO, ICH-GCP, EDC, Biotechnology
Education
North Carolina State University 1998 — 2002
BS, Microbiology
Harvard Clinical Research Institute October 2013 - Present
Clinsys Clinical Research March 2011 - October 2013
Clinsys March 2008 - March 2011
Clinsys Clinical Research January 2007 - March 2008
Sepracor May 2003 - January 2007
Sepracor Pharma 2003 - 2007
INC Research 1999 - 2003
Cato Research 1996 - 1997
PAREXEL 1995 - 1997
PPD 1995 - 1996
Skills
CRO, Clinical Trials, CTMS, GCP, Clinical Development, EDC, Clinical Monitoring, Pharmaceutical Industry, Oncology, Clinical Research, Therapeutic Areas, Clinical Data Management, ICH-GCP, Biotechnology, Sop, FDA, Regulatory Affairs, Regulatory Submissions, Infectious Diseases, Drug Development, Lifesciences, Clinical Study Design, Medical Devices, CRF design, Pharmacovigilance, Protocol, Clinical Operations, IND, 21 CFR Part 11, Medical Writing, Neurology, Data Management, Vaccines, Medical Affairs, Patient Recruitment, Inform, Project Management, Management, Dermatology, Oracle Clinical, Biopharmaceuticals, Phase I, Trial Management, Endocrinology
Education
Western Carolina University 2003 — 2005
Masters of Project Management, Project Management
Rutgers University 1989 — 1993
Bachelor of Arts, Biology
Agility Clinical, Inc. July 2015 - Present
SynteractHCR August 2014 - July 2015
Bristol-Myers Squibb May 2014 - August 2014
SynteractHCR March 2013 - May 2014
Synteract, Inc. August 2009 - March 2013
Cato Research April 2008 - August 2009
Cato Research October 2006 - October 2008
Cato Research February 2005 - October 2006
Skills
Clinical Trials, CRO, CTMS, GCP, EDC, Oncology, Clinical Research, FDA, Clinical Monitoring, Drug Development, Pharmaceutical Industry, Biotechnology, ICH-GCP, Clinical Development, Regulatory Affairs, Clinical Study Design, Therapeutic Areas, Protocol
Education
North Carolina State University 2004 — 2008
Bachelor's degree, Postbaccalaureate studies in statistics, microbiology and zoology
North Carolina State University 2000 — 2004
B.A., Psychology, Genetics
Quintiles January 2015 - Present
Quintiles December 2013 - January 2015
LGBT in the South Conference 2015 - 2015
LGBT in the South Conference 2015 - 2015
LGBT in the South Conference 2015 - 2015
Duke Clinical Research Institute March 2013 - December 2013
Duke Clinical Research Institute June 2011 - March 2013
Duke Clinical Research Institute August 2007 - June 2011
Cato Research December 2005 - July 2007
Cato Research December 2004 - December 2005
Skills
CRO, GCP, Clinical Trials, CTMS, Clinical Research, EDC, Clinical Development, Infectious Diseases, Protocol, Drug Development, ICH-GCP, Process Improvement, Clinical Monitoring, Oncology, Regulatory Affairs, Neurology, Change Management, Leadership, Clinical Data Management, Psychiatry, Strategy, Therapeutic Areas, Clinical Trial..., Psychology, Customer Service, Employee Management, Employee Training, Central Nervous System, CNS, Strategy Development, Training & Development, Personnel Management, Staff Development, Staff Management, Training, Training Delivery, Program Management, Program Evaluation, Neuroscience, Client Liaison, Project Closeout, Project Start-up, Project Management, Clinical, Program evalu, Facilitation, Customer Satisfaction, Stakeholder Analysis, Schedule Development, Earned Value Management
Education
North Carolina State University 1997 — 2002
Bachelor of Science, Zoology
University College Cork 2001 — 2001
Honors, Zoology/Animal Biology
Chiesi Pharmaceuticals Inc. 2008 - 2015
Supernus Pharmaceuticals, Inc. (formerly Shire Laboratories / Shire plc) 2005 - 2008
Shire 2003 - 2004
Sucampo Pharmaceuticals, Inc. 2003 - 2003
Cato Research 1999 - 2003
Johns Hopkins University, Montgomery County Campus 2001 - 2002
Skills
Regulatory Strategy..., Regulatory Affairs, Drug Development, Regulatory Submissions, IND, NDA, FDA, Clinical Research, Orphan Designation /...
Education
The George Washington University
Doctor of Philosophy (Ph.D.), Genetics
Mount Holyoke College
Bachelor’s Degree, Chemistry Major; Biology Minor
Stone Ridge Country Day School
High School
Algorithme Pharma September 2013 - Present
Cato Research November 2006 - September 2013
Quintiles June 1999 - December 2005
Skills
EDC, CRO, Clinical Data Management, Oracle Clinical, CDISC, CRF design, ICH-GCP, GCP, Inform, Clinical Trials, 21 CFR Part 11, Clinical Development, Pharmaceutical Industry, Clinical Research, Data Management, Clinical Study Design, Validation
Education
Université de Montréal 1996 — 1999
Bacc, Mathematiques Informatique
Université de Montréal - Ecole polytechnique de Montréal 1995 — 1996
Amgen July 2013 - Present
Amgen June 2006 - July 2013
Shire Pharmaceuticals April 2003 - June 2006
Cato Research April 2001 - April 2003
Education
The Johns Hopkins University 2002 — 2004
MS, Biotechnology
University of California, San Diego 1995 — 1999
BS, Biology
Bristol-Myers Squibb July 2015 - Present
Bristol-Myers Squibb October 2013 - July 2015
BMS February 2004 - October 2013
Cato Research 2000 - 2005
Queens College 1994 - 1996
Education
Queens University of Charlotte 1991 — 1996
BSN, Nursing
high school 1964 — 1968
Cato Research August 2013 - Present
Cato Research January 2012 - July 2013
Charles River Laboratories September 2009 - January 2012
Genizon BioSciences June 2007 - April 2009
Concordia University June 2006 - June 2007
Skills
Clinical Trials, GCP, CRO, Clinical Research, Sop, Biotechnology, ICH-GCP, Lifesciences, Pharmaceutical Industry, Clinical Data Management, Clinical Monitoring, EDC, CTMS, ELISA, Cytometry, Cell Culture, ECL, Luminex, Immunogenicity, Toxicology, Clinical Development, Drug Development
Education
University of Montreal 2005 — 2006
Certificat, Criminology
Université du Québec à Montréal 2002 — 2005
Bachelor of Science (B.Sc.), Biology
Sucampo Pharmaceuticals, Inc. November 2012 - Present
Sucampo Pharmaceuticals, Inc. March 2012 - Present
Sucampo Pharmaceuticals, Inc. September 2011 - Present
Salix Pharmaceuticals, Inc. September 2006 - April 2011
Cato Research May 2001 - September 2006
Education
Texas A&M University 1988 — 1993
Ph.D., Chemistry
St. Olaf College 1984 — 1987
B.A., Chemistry
PRA Health Sciences May 2015 - Present
Ockham Development Group May 2012 - Present
Cato Research July 2009 - May 2012
Premier Research Group September 2008 - May 2009
Pfizer Inc. January 2008 - August 2008
MaxisIT Inc. January 2007 - December 2007
Skills
CDISC, SDTM, ADaM, SAS, SAS/SQL, Clinical Trials, Statistical Programming, Clinical Data Management, Data Management, Statistics, Data Analysis, Validation, Pharmaceuticals, SQL, Oncology, Programming, FDA, Databases, Analysis, Excel, Biostatistics, Microsoft Office, PowerPoint, Problem Solving, 21 CFR Part 11, Pharmaceutical Industry, SAS programming, CRO, GCP, EDC, Clinical Development, Clinical Research, Biotechnology
Education
The University of Texas at Arlington 2004 — 2006
Master of Business Administration (MBA)
JB Life Sciences January 2008 - Present
PharmaDirections January 2008 - November 2008
King Pharmaceuticals January 2007 - December 2007
Cato Research July 2004 - January 2007
AAI Pharma May 2001 - July 2003
Aventis Life Sciences 1999 - 2001
Rhone-Poulenc 1987 - 2001
Monsanto 1976 - 1986
Skills
Drug Development, Drug Discovery, Pharmaceutical Industry, Regulatory Affairs, CRO, CMC, Regulatory Submissions, FDA, Clinical Development, Lifesciences, R&D, CMC Regulatory Affairs, CMC development, Analytical Chemistry, Medicinal Chemistry, IND, GLP
Education
Northwestern University 1975 — 1976
Post Doctoral, Medicinal Chemsitry, Biochemistry
The Johns Hopkins University 1971 — 1975
Ph.D., Chemistry
Cato Research March 2013 - Present
Pamlico Pharma March 2009 - March 2012
Serenex January 2004 - July 2008
Serenex July 2001 - January 2004
Skills
Protein Purification, Protein Expression, Proteomics, Assay Development, Drug Discovery, Pharmacokinetics, Project Management, Biomarker Discovery, Biomarker Development
Education
University of Virginia 1992 — 1997
PhD, Physiology
Miami University 1986 — 1991
Bachelor's degree, Manufacturing Engineering
Algorithme Pharma May 2009 - Present
Cato Research April 2006 - May 2009
TD Meloche Monnex 2005 - 2006
Montreal Heart Institute- Coordinating Center - MHICC April 2002 - June 2005
Novartis October 2001 - April 2002
Quintiles 1998 - 2001
Skills
Clinical Research, Clinical Trials, CRO, SAS, Clinical Data Management
Education
Université de Montréal 1995 — 1998
B.Sc., Informatique et Recherche Opérationnelle
CEGEP Lionel-Groulx 1992 — 1994
DEC, Sciences Pures
Externat Sacré-Coeur 1987 — 1992
DES
CTI Clinical Trials and Consulting May 2013 - Present
Quintiles April 2010 - November 2011
Drug Safety Alliance February 2008 - April 2010
DSA May 2007 - February 2008
Salix November 2004 - May 2007
Cato Research 2002 - 2004
Skills
CRO, GCP, Clinical Trials, Regulatory Submissions, Regulatory Affairs, Pharmacovigilance, Pharmaceutical Industry, Clinical Development, CTMS, FDA, ICH-GCP, Oncology, EDC, Data Management, Sop
Education
North Carolina State University 1996 — 2000
Bachelor of Science, Zoology/Animal Biology
Beddingfield High School 1992 — 1996
Cato Research May 2008 - Present
University of North Carolina at Chapel Hill October 2007 - April 2008
Skills
Lifesciences, Biotechnology, Immunology, CTMS, Biochemistry, Pharmaceutical Industry, GCP, Cancer, Drug Discovery, Vaccines, Clinical Study Design, Regulatory Submissions, Regulatory Affairs, Biology, Microscopy, Data Management
Education
University of North Carolina at Chapel Hill 2002 — 2007
PhD, Pathoolgy
Providence College 1998 — 2002
BS, Biology
NeuroPace December 2008 - Present
Pharmanet November 2006 - October 2008
Pharmanet 1999 - 2008
Cato Research November 2003 - November 2006
CATO Research 2004 - 2006
Pfizer 2002 - 2004
Pfizer January 2002 - November 2003
Pharmanet November 1999 - January 2002
Omnicare November 1997 - November 1999
Covance September 1996 - November 1997
Education
Naval Postgraduate School 1980 — 1982
MS, Operations Research
Washburn University 1967 — 1968
BA, Biology
SRA International November 2002 - Present
Cato Research 1997 - 2003
Education
North Carolina State University 1993 — 1997
BS, Zoology
Agility Clinical, Inc. February 2013 - Present
Synteract, Inc. February 2009 - February 2013
Cato Research October 2006 - February 2009
Cato Research June 2005 - October 2006
UNC-CH, Department of Immunology and Microbiology January 2003 - June 2005
Skills
Clinical Monitoring, Oncology, Clinical Trials, EDC, Immunology, Clinical Research
Education
North Carolina State University 1997 — 2001
BS, Biology
Echo Therapeutics, Inc. June 2008 - December 2014
Cato Research 2004 - 2008
Investors Title Insurance Company 2002 - 2004
Devine Millimet & Branch 1999 - 2002
Skills
Corporate Governance, Licensing, Corporate Law, Intellectual Property, Mergers & Acquisitions, Legal Compliance, Contract Negotiation, Due Diligence, Venture Capital, SEC filings, Joint Ventures, Biotechnology, Strategy, Pharmaceutical Industry, Medical Devices, Mergers, Private Equity, Securities, Document Review, Securities Regulation, General Corporate..., Corporate Compliance, Executive Management, Risk Management, Life Sciences, Proxy Statements, Litigation Management, Human Resources, Management, Employment Law, Start-ups, Leadership, Clinical Trials, Strategic Planning
Education
The College of William and Mary - Marshall Wythe Law School 1996 — 1999
JD
Mount Holyoke College 1992 — 1996
BA
PAREXEL May 2015 - Present
Cato Research January 2011 - Present
Cato Research January 2013 - April 2015
Arena Pharmaceuticals September 2007 - January 2011
Illumina November 2006 - September 2007
Ichor Medical Systems 2004 - 2005
Skills
Pharmaceutical Industry, FDA, Validation, Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Clinical Development, Lifesciences, GLP, CRO, Clinical Trials, Biotechnology, Medical Devices, Sop, IND, GCP, Drug Development, EDC, Oncology, Analytical Chemistry, Quality Assurance, Clinical Research, Clinical Monitoring, Quality Auditing, Drug Safety, GMP, Protocol, Pharmacokinetics, SOP
Education
San Diego State University-California State University 2000 — 2005
BS, Cellular and Molecular Biology
Cato Research October 2005 - Present
Pfizer August 2004 - October 2005
Cato Research June 2002 - August 2004
Education
Université de Montréal 1999 — 2001
M. Sc. Pharmacology
Kara Consultant August 2007 - Present
MethylGene Inc. 2006 - 2007
Cato Research 2004 - 2006
Bristol-Myers Squibb 2002 - 2004
Anapharm December 1999 - December 2001
Skills
Clinical Research, GCP, CRO, Clinical Development, CTMS, Clinical Monitoring, Clinical Trials, ICH-GCP, Oncology, EDC, Therapeutic Areas, Infectious Diseases, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Clinical Operations, Research, Cardiology
Education
Université Laval 1995 — 2000
Master’s Degree, immunology
Université Laval 1991 — 1994
B.Sc., Biology
Cato Research January 2013 - Present
PharmaNet Development Group, Inc. July 2007 - December 2012
United Therapeutics February 2005 - June 2007
Tab Clinical Trials August 2004 - January 2005
Triangle Orthopaedic Associates July 2003 - August 2004
Williams-Sonoma, Inc. 1999 - 2004
Skills
EDC, GCP, Clinical Trials, Protocol, Sop, Clinical Research, CRF design, CRO, CTMS, Clinical Study Design, Clinical Development, Clinical Monitoring, ICH-GCP, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry
Education
University of the Sciences in Philadelphia 2007 — 2009
MBA, Pharmaceutical Business
Durham Technical Community College 2002 — 2004
CTRA, Clinical Research
North Carolina State University - College of Management 1997 — 1999
B.S., Management - Marketing
Wake Forest University 1995 — 1996
Management
PPD April 2014 - Present
PPD June 2006 - March 2014
PPD October 2005 - June 2006
PPD June 2004 - October 2005
PPD June 2001 - June 2004
PPD June 1999 - June 2001
PAREXEL 1998 - 1999
Cato Research July 1992 - November 1995
Skills
Strategy, Project Management, CRO, Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Clinical Operations, ICH-GCP, CTMS, GCP, Sop, Budgets, Clinical Data Management, Clinical Research, Clinical Monitoring, FDA, Training, Clinical Development, Regulatory Affairs, Quality Assurance
Education
North Carolina Central University 1986 — 1991
B.A., Public Administration
Aviat Networks July 2014 - Present
Cree November 2013 - July 2014
Global Knowledge Training May 2011 - October 2013
Aviat Networks (formerly Harris Stratex) May 2008 - March 2011
etrials Worldwide 2007 - 2008
PPD 2004 - 2007
Quintiles 2001 - 2004
Cato Research 2000 - 2001
Covance 1998 - 2000
Coopers & Lybrand 1994 - 1998
Skills
Sarbanes-Oxley Act, Forecasting, Financial Reporting, Accounting, Finance, Leadership, Management, Revenue Recognition, Financial Analysis, Variance Analysis, Strategic Financial..., Managerial Finance, US GAAP, GAAP, Internal Controls, Auditing, Cost Accounting, Consolidation, General Ledger
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 1993 — 1994
MAC, Accounting
North Carolina State University 1983 — 1988
BA, Business Management, Economics
SciLucent, LLC January 2014 - Present
DR Consulting (DRC) September 2013 - January 2014
Bristol-Myers Squibb June 2012 - September 2013
Amylin Pharmaceuticals Inc July 2006 - June 2012
Cato Research 2001 - 2006
Cato Research 1999 - 2001
Charles River Laboratories June 1998 - June 1999
Endoresearch March 1997 - June 1998
Skills
International Drug..., Nonclinical Safety..., Inhalation Toxicology, Reproductive Toxicology, CRO Outsourcing and..., GLP Audits & Study..., Regulatory Submissions..., Pre-IND, IND/CTA,..., Drugs, Biologics,...
Education
Université Laval 1994 — 1997
Ph.D., Physiology-Endocrinology
Université Laval 1992 — 1994
M.Sc., Experimental Medicine
Université Laval 1989 — 1992
B.Sc., Biology
Polyvalente Mont Saint-Anne
InSymbiosis May 2009 - Present
Cato Research June 2000 - January 2009
Cato Research June 2000 - January 2009
Skills
CRO, Drug Development, Regulatory Submissions, Toxicology, Pharmaceutics, Oncology, Biologics, Lifesciences, Pharmaceutical Industry, Biotechnology, Drug Discovery, Program Management, GLP, Sop, Regulatory Affairs, Pharmacology, FDA
Education
Université de Montréal 1988 — 1994
Ph.D., Pharmacology
Université du Québec à Trois-Rivières 1983 — 1986
B.Sv., Biochemistry
MabVax Therapeutics, Inc. May 2013 - Present
BENNETT Clinical Research SOLUTIONS February 2009 - Present
MabVax Therapeutics, Inc. May 2010 - May 2013
Phenomix 2006 - 2009
Cato Research 1996 - 2006
Skills
Case Report Forms, Clinical Trials, Clinical Development, CRO, GCP, Clinical Operations, Sop, Trial Management, Pharmaceutical Industry, Drug Development, Regulatory Submissions, Clinical Research, Clinical Study Design, Leadership, CTMS, Oncology, Protocol, Biotechnology
Education
University of Calgary 1972 — 1982
BN, Nursing
The University of Calgary
BN, Nursing Education
Cato Research October 2014 - Present
Cato Research June 2014 - Present
Cato BioVentures March 2013 - Present
Cato Research June 2011 - June 2014
Cato Research April 2010 - June 2014
Cato Research August 2008 - April 2010
Cato Research September 2005 - August 2008
Cato Research February 2002 - September 2005
Skills
Excutive Management, Marketing Management, Collection Development, Pharmaceutical Industry, CRO, Clinical Trials, GCP, CTMS, Marketing, Clinical Development, Drug Development, EDC, Regulatory Submissions, Regulatory Affairs, Oncology, Clinical Monitoring, Biotechnology, FDA, Therapeutic Areas, ICH-GCP, Lifesciences, Medical Writing, Vaccines, Protocol, Sop, Management, Infectious Diseases, Clinical Research, Cross-functional Team..., Strategy
Education
North Carolina State University 1996 — 2000
Bachelor of Science (B.S.), Animal Sciences
North Carolina State University 1996 — 2000
Bachelor of Science (B.S.), Animal Sciences
Velan Inc. March 2011 - Present
Cato Research March 2005 - March 2011
Gexel Telecommunications July 2004 - March 2005
Skills
Employee Relations, HRIS, Talent Acquisition, Talent Management, Performance Management, Human Resources
Education
Université de Montréal 1999 — 2002
Bachelor's, Industrial Relations
PRA Health Sciences May 2015 - Present
Cato Research April 2013 - May 2015
Cato Research December 2011 - May 2015
Cato Research Israel Ltd. October 2010 - November 2011
Albert Einstein College of Medicine August 2009 - August 2010
Synergy Research Inc. April 2008 - August 2009
Skills
Oncology, Clinical Trials, Clinical Monitoring, IRB, Clinical Study Design, GCP, Pharmaceutical Industry, CTMS
Education
Rutgers University-New Brunswick 2003 — 2008
B.A., Sociology, Pre-Medicine
Cato Research February 2011 - Present
GlaxoSmithKline November 2009 - March 2010
GlaxoSmithKline October 2006 - October 2009
GlaxoSmithKline January 2002 - October 2006
Woolf Group January 2001 - December 2001
TAB Consulting, Inc November 1995 - December 2000
Skills
Medical Writing, Clinical Development, Clinical Trials
Education
Northwestern University 1990 — 1994
PhD, Chemistry
University of California, Berkeley 1988 — 1990
Chemistry
Purdue University 1985 — 1988
BS, Chemistry
North Carolina School of Science and Mathematics 1983 — 1985
High School
Robert Half International July 2011 - Present
The Experts, Inc. November 2010 - May 2011
NIMS April 2008 - July 2010
Cato Research May 2006 - April 2008
Skills
Financial Reporting, SOX, SEC reporting, Compliance, GAAP, Accounting, Internal Controls, Revenue Recognition, Budgeting, Cash Management, Consolidation, General Ledger, Mergers, Financial Analysis, Financial Control, Forecasting, Accounts Payable, Quickbooks, Cash Flow, Accounts Receivable, Inventory Management, Accruals, Due Diligence, Reconciliation, Process Improvement, IFRS, US GAAP, Cost Reduction, Sarbanes-Oxley Act, Budgets, Analysis, Account Reconciliation, Financial Statements, Mergers & Acquisitions, Sarbanes-Oxley, Payroll, Great Plains Software, Tax, External Audit, Management Accounting, Bank Reconciliation, Variance Analysis, Auditing, Management, Finance, Executive Management, Leadership, CPA
Education
Southern New Hampshire University 1980 — 1986
Bachelor's Degree, International Business with concentration in Accounting, 3.68
Cato Research June 2011 - Present
Quintiles December 2010 - June 2011
Lundbeck April 2009 - December 2010
LEO Pharma 2007 - 2008
Cato Research 2002 - 2007
Skills
GCP, Clinical Trials, ICH-GCP, CTMS, EDC, Pharmaceutical Industry, CRO, Therapeutic Areas, Clinical Operations, Clinical Research, Clinical Monitoring, Clinical Development, Oncology, Regulatory Submissions, Drug Development, Clinical Data Management, Biotechnology, Regulatory Affairs, Infectious Diseases, Critical Thinking, SOP
Education
Mount Allison University 1997 — 2001
B.Sc., Mathematics
Cato Research March 2010 - Present
Cato Research February 2009 - March 2010
Cato Research June 2007 - February 2009
Cato Research June 2002 - June 2007
Cato Research June 2000 - June 2002
Skills
Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, Regulatory Submissions
Education
North Carolina State University 1996 — 2000
Animal Science, Anatomy, Physiology, Chemistry, Biology, Busniess Management
INC Research September 2010 - Present
Cato Research July 2007 - August 2010
North Carolina State University July 2006 - July 2007
Education
North Carolina State University 2002 — 2006
BA, Communication
Chiesi USA, Inc. April 2015 - Present
GlaxoSmithKline August 2011 - April 2015
Pfizer, Inc. (formerly King Pharmaceuticals Research & Development,Inc.) January 2010 - August 2011
Cato Research March 2007 - December 2009
Cato Research September 2005 - March 2007
Cato Research July 2002 - September 2005
Monsanto 1989 - 1995
Skills
FDA, IND, Oncology, Regulatory Affairs, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Neurology, Clinical Trials, Life Sciences, Biotechnology
Education
University of Washington 1995 — 2001
Ph.D., Pharmacology
Northwestern University 1991 — 1995
BA, Chemistry
Cato Research 2004 - Present
Skills
Oncology, CTMS, Clinical Trials, CRO, GCP, Biotechnology, FDA, Pharmaceutical Industry, Clinical Monitoring, Clinical Development
Education
North Carolina State University 1997 — 2001
B.S.
Bellicum Pharmaceuticals, Inc. November 2014 - Present
Targacept, Inc. February 2002 - November 2014
Osiris Therapeutics January 2001 - January 2002
Cato Research 1997 - 2001
Duramed Pharmaceuticals January 1995 - March 1997
Pfizer 1989 - 1995
KPMG Peat Marwick 1984 - 1987
Skills
Pharmaceutical Industry, Biotechnology, Financial Analysis, Clinical Development, Financial Reporting, IPO, Investor Relations, Business Strategy, Strategic Partnerships
Education
Thunderbird School of Global Management 2008 — 2008
MIM, International Busines and Finance
Saint Mary's College of California 1980 — 1984
BS, Accounting
Quintiles January 2011 - Present
Quintiles December 2005 - January 2011
Quintiles April 2003 - December 2005
Quintiles September 2001 - April 2003
Ingenix June 2000 - September 2001
GlaxoWellcome June 1999 - June 2000
PPD October 1996 - May 1999
GlaxoWellcome August 1995 - October 1996
Cato Research 1995 - 1995
Education
North Carolina State University 1990 — 1995
BA, Chemistry
North Carolina State University 1990 — 1994
BS, Biology
DSM May 2013 - Present
Martek Biosciences July 2006 - April 2013
Martek Biosciences May 2004 - June 2006
Cato Research 1998 - 2004
Skills
Nutrition, Neurology, Clinical, Neuroscience, Pharmacology, Clinical Trials, Clinical Research, Clinical Development, GCP, Clinical Trial..., Medical Writing, Biotechnology, CRO, IND, Protocol Development, Sop, CTMS, ICH-GCP, Drug Development, Clinical Data Management, Clinical Operations, Cross-functional Team..., Clinical Study Design, Therapeutic Areas, CRF design, 21 CFR Part 11, Protocol, Life Sciences, Pharmaceutical Industry, Lifesciences, Immunology
Education
Medical College of PA 1987 — 1994
PhD, Pharmacology
University of Hartford 1981 — 1983
MA, Neuroscience
Roanoke College 1977 — 1981
BA, Psychology
Array BioPharma Inc. April 2015 - Present
Chiltern March 2014 - April 2015
INC Research September 2012 - February 2014
Cato Research 2009 - September 2012
Cato Research October 2007 - September 2012
Medical College of Georgia 2002 - 2007
Medical College of Georgia 2004 - 2005
Skills
Clinical Trials, Molecular Biology, Toxicology, Clinical Research, Oncology, Research, CRO, CTMS, GCP, Clinical Monitoring, Regulatory Affairs, Clinical Study Design, EDC, Biotechnology, Drug Development, Medical Writing, Lifesciences, Clinical Development, ICH-GCP
Education
North Carolina State University 1997 — 2002
Ph.D., Environmental and Molecular Toxicology
The University of Georgia 1993 — 1997
BS, Environmental Health Sciences
Neural Ideas Inc. July 2012 - Present
Parametric Sound/Turtle Beach Corporation April 2012 - Present
Self Employed Contractor December 2010 - July 2012
Orthoscan January 2011 - February 2012
Strategic Operations April 2010 - January 2011
SAIC August 2009 - March 2010
Trusonic, Inc. July 2006 - September 2006
Cato Research July 2006 - September 2006
SAIC June 2005 - September 2005
Skills
C++, Assembly, C, Matlab, Linux, Java, SQL, Microcontrollers, DSP, Solidworks, CAMWorks, CNC Programming, Robotics, Software Engineering, Manufacturing, Engineering, Digital Signal...
Education
The University of Manchester 2005 — 2009
BEng, Mechatronics
San Diego High School 2001 — 2005
DP Clinical November 2011 - Present
CATO Research March 2000 - January 2011
Skills
CRO, CRF design, Clinical Data Management, Oracle Clinical, OC RDC, EDC, Databases, Data Entry, Database Design, Database Administration, GCP, Validation, SQL, Management
Education
Strayer University-Maryland 2011 — 2013
BS, Computer Information Systems, 3.8
Strayer University-Maryland 2007 — 2011
Associate of Arts (A.A.), Computer and Information Sciences, General, 3.9
Raymond Buck Consulting February 2005 - Present
Cato Research February 1989 - February 2005
Ortho-McNeil Pharmaceutical September 1984 - January 1989
Skills
Clinical Trials, CRO, Clinical Development, Oncology, GCP, Clinical Research, CTMS, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Medical Writing, FDA, SAS, Lifesciences, Medical Devices, Immunology, Regulatory Submissions, Drug Development, Biostatistics, Data Management
Education
University of North Carolina at Chapel Hill 1977 — 1984
PhD, Biostatistics
University of Alabama 1974 — 1977
BS magna cum laude, Mathematics
ICON Clinical Research December 2005 - Present
Duke Clinical Research Institute May 2004 - November 2005
i3 Research February 2002 - May 2004
Quintiles May 1999 - February 2002
United Therapeutics April 1998 - February 1999
Cato Research March 1991 - June 1997
Skills
EDC, Clinical Monitoring, Neurology, Clinical Development, CRO, Clinical Trials, Therapeutic Areas, Regulatory Submissions, GCP, ICH-GCP, Medical Devices, CTMS, Clinical Operations, Pharmaceutical Industry, Clinical Research
Education
North Carolina Wesleyan College 2002 — 2004
BS, Business Administration
Cato Research August 2010 - Present
Cato Research March 2004 - July 2010
Allergan Medical Optics 1989 - 1999
Baxter Edwards Laboratories 1984 - 1989
Education
University of California, Berkeley 1980 — 1984
Bachelor of Science (B.S.), Microbiology and Immunology
Algorithme Pharma March 2012 - Present
Algorithme Pharma July 2008 - March 2012
Cato Research October 2007 - July 2008
Skills
Pharmacology, GCP, Clinical Research, GLP, Drug Development, CRO
Education
2005 — 2007
M.Sc
2002 — 2005
B.Sc.
Fashion Lyfe, LLC June 2015 - Present
Anonymous November 2013 - Present
INC Research (formerly Kendle International) May 2008 - November 2013
Cato Research January 2007 - April 2008
Skills
Clinical Trials, Forecasting, Variance Analysis, Pharmaceutical Industry, CRO, Clinical Development, Clinical Research, EDC, Oncology, GCP, Microsoft Excel
Education
North Carolina State University
BS/BA, Accounting/Political Science
Rutgers Business School
Master's Degree, Accounting
Kolltan Pharmaceuticals, Inc. September 2013 - July 2015
EntreMed, Inc. June 2001 - May 2012
Cato Research 1993 - 2001
Skills
Clinical Trials, Regulatory Submissions, Oncology, Biopharmaceuticals, Clinical Development, Regulatory Affairs, CRO, CTMS, Clinical and Regulatory..., Regultory Submissions, Hematology, Vaccines, Infectious Diseases, EDC, FDA, Clinical Data Management, GCP, GMP, Medical Writing, Technology Transfer, Therapeutic Areas, Sop, Commercialization, Drug Discovery, Early clinical trials
Education
Thomas Jefferson University
Doctor of Medicine (MD), Hematology/oncology
University of Delaware 1972 — 1974
Master of Business Administration (MBA), Marketing
Syracuse University
BS, Biochemistry
Synthon February 2009 - Present
UCB Pharma March 2007 - December 2009
Schwarz Biosciences February 2006 - November 2007
AAIPharma Services Corp. 2002 - January 2006
DSM Pharmaceuticals 2000 - 2002
DSM Pharmaceuticals 1999 - 2000
Cato Research 1997 - 1999
Cato Research 1994 - 1997
Cato Research 1993 - 1994
Skills
Regulatory Submissions, Pharmaceuticals, GMP, Change Management, Strategic Planning, Product Development, Writing, Business Strategy, Negotiation, Biotechnology, Budgeting, Product Management, Team Leadership, Quality Assurance, Due Diligence, Compliance, Medical Devices, Research, Pharmaceutical Industry
Education
Meredith College 1988 — 1992
Bachelor of Science, Biology
GSK Oncology February 2007 - Present
Cato Research 1999 - 2007
Skills
Clinical Development, Clinical Trials, Drug Development, Oncology, Pharmaceutical Industry, GCP, CRO, Medical Writing, Regulatory Submissions, IND, Clinical Operations, Translational Medicine, Clinical Study Design, ICH-GCP, Clinical Research, Cancer, Regulatory Affairs
Education
Wesleyan University 1993 — 1999
Doctor of Philosophy (PhD), Biology
Universitatea din București / University of Bucharest 1987 — 1992
Master of Science (MSc), Biophysics
Allscripts January 2013 - Present
Dex One March 2007 - January 2013
Cato Research October 2006 - March 2007
Cato Research August 1998 - October 2006
Interim HealthCare July 1996 - August 1998
Skills
Revenue Recognition, Variance Analysis, Sarbanes-Oxley Act, GAAP, General Ledger, Hyperion Enterprise, SEC filings, Financial Reporting, Sarbanes-Oxley, US GAAP, Financial Analysis, Account Reconciliation, Process Improvement, Oracle R12 Financials, Accounting, Financial Accounting, Essbase
Education
Siena College 1992 — 1996
Bachelor of Business Administration (BBA), Accounting
Banner Life Sciences December 2005 - Present
Banner Pharmacaps Inc. December 2005 - Present
GSK 2002 - 2004
Cato Research 2001 - 2002
Skills
FDA, GMP, Regulatory Affairs, Regulatory Submissions, Sop, Clinical Trials, Regulatory Requirements
Education
The Johns Hopkins University 2009 — 2013
Regulatory Science, Biotechnology, Masters Degree
North Carolina State University 1996 — 2000
Biological Sciences, Biology/Biological Sciences, General, Bachelors Degree