PPD Development
Industry: Pharmaceutical company
DescriptionThe Pharmaceutical Product Development, LLC is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. Headquarters: Wilmington, NC CEO: David Simmons Number of employees: 20,000 (2017) Founder: Fredric N Eshelman Subsidiaries: EVIDERA, Acurian, Inc., PPD Japan K.K., Parent organization: Jaguar Holding Company I
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PPD Development Employees
Quintiles Transnational May 2011 - Present
KENDLE INTERNATIONAL INC September 2009 - May 2011
KENDLE INTERNATIONAL INC January 2009 - August 2009
UCB, Inc. March 2006 - December 2008
UCB PHARMA (RPS CONSULTANT) February 2003 - March 2006
UCB PHARMA (RPS CONSULTANT) May 2002 - February 2003
PPD DEVELOPMENT July 2001 - May 2002
INGENIX - Clinical Research Associate (Regional) July 1999 - July 2001
CALIFORNIA CLINICAL TRIALS MEDICAL GROUP January 1998 - July 1999
National Institutes of Health January 1996 - January 1998
Skills
Clinical Trials, CRO, Clinical Development, Oncology, Regulatory Submissions, Clinical Research, Protocol, Sop, Regulatory Affairs, FDA, Clinical Operations, Clinical Study Design, CTMS, GCP, EDC, Medical Affairs, Rheumatoid Arthritis
Education
Virginia Polytechnic Institute and State University 1992 — 1997
BS, Biology
Virginia Polytechnic Institute and State University (Virginia Tech) 1992 — 1997
B.S, Biology
The George Washington University
Masters, Clinical Research Administration
PPD Development March 2011 - Present
PPD Development August 2005 - February 2011
Skills
GMP, 7 years of cGMP..., 16 years of in lab..., Extensive knowledge in..., Biopharmaceuticals, Molecular Biology, Vaccines, Laboratory, CRO, HPLC, Analytical Chemistry, Biotechnology, Chromatography, FDA, GLP, Protein Chemistry, Sop, Validation
Education
University of Wisconsin-Madison
M.Sci.
University of Shanghai for Science and Technology
Credit Suisse July 2013 - Present
Children's Creativity Museum 2011 - Present
RBC Capital Markets 2009 - May 2013
Morgan Stanley March 2006 - January 2009
Credit Suisse First Boston August 2004 - March 2006
ALZA Corporation (J&J) June 2003 - August 2003
Gilead Sciences November 2001 - August 2002
BioStreet.com September 2000 - July 2001
PPD Development June 1998 - August 2000
Quintiles April 1995 - March 1997
Skills
Biotechnology, Lifesciences, Healthcare, Licensing, Clinical Research, Corporate Development, Financial Modeling, Venture Capital, Valuation, Mergers, Due Diligence, Private Equity, Competitive Analysis, Mergers & Acquisitions, Pharmaceutical Industry, Biotechnology Industry, IPO, Investment Banking, Corporate Finance, M&A experience, Strategy, Acquisitions, Investor Relations, Life Sciences, Business Development
Education
Tuck School of Business at Dartmouth College 2002 — 2004
MBA
University of California, San Diego 1989 — 1994
B.S. / B.A.
Menlo Atherton High School
Physicians Allied Health Professionals Group January 2014 - November 2014
Blood Systems Inc. January 2013 - October 2013
Seton Medical Center February 2011 - August 2012
PPD Development March 2010 - July 2011
PPD Development February 2008 - February 2010
Skills
Laboratory Automation, Microsoft Office, Microsoft Excel, PowerPoint, Pay Close Attention to..., Work Well Independently, Works well in a team, Work in A Fast Paced...
Education
The University of Texas at Austin 2004 — 2010
Bachelor's degree, Spanish
Austin Community College 2011 — 2012
Associate of Science (A.S.), Medical Laboratory Technology
PATH November 2014 - Present
Bill & Melinda Gates Foundation January 2013 - November 2014
Bill & Melinda Gates Foundation October 2010 - January 2013
Bill & Melinda Gates Foundation April 2009 - October 2010
Biomedical Systems August 2008 - April 2009
PRA International February 2006 - July 2008
Ockham Ventures December 2004 - February 2006
PPD Development August 2004 - December 2004
PPD Development March 2000 - July 2004
STATPROBE 1998 - 2000
Skills
Clinical Trials, CRO, Clinical Research, Infectious Diseases, Strategic Planning, Vaccines, Venture Capital, Lifesciences, Biotechnology, Pharmaceutical Industry, Business Development, Competitive Analysis, Project Management, Business Strategy, Healthcare, Start-ups, Clinical Development, Global Health, Strategic Partnerships, GCP, Drug Development, R&D, Oncology, Cross-functional Team..., Leadership, Immunology, Management, Program Management, Strategy, Executive Management, Nonprofits, Research, Life Sciences, Biopharmaceuticals, Mentoring
Education
Seattle University 2009 — 2012
MBA
University of Washington 1986 — 1997
PhD
Williams College 1985 — 1986
Punahou School 1979 — 1985
HSD
Self-employed Consultant CRAISTA PharmaceuticalsOctober 2007 - November 2009
Clinical Research Center of Nevada February 2009 - February 2009
Cevelex, Inc. October 2008 - January 2009
EnVision Clinical Research Consulting, Inc. March 2008 - June 2008
Altana Pharma April 2006 - October 2007
Kforce January 2005 - December 2005
PPD Development 2002 - 2005
SciRex 1996 - 1996
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, GCP, ICH-GCP
Education
The University of Texas at Austin 1992 — 1995
ICON plc March 2014 - Present
ICON plc August 2011 - February 2014
GlaxoSmithKline August 2002 - August 2011
GlaxoSmithKline August 2002 - August 2011
Mark / Marks Consulting, LLC August 1998 - June 2010
Ingenix Pharmaceutical Services August 2001 - August 2002
Ingenix Pharmaceutical Services August 2000 - August 2002
i3 Research 2000 - 2002
Ingenix Pharmaceutical Services August 2000 - August 2001
PPD Development February 1999 - August 2000
Skills
Clinical Research, Clinical Trials, Clinical, Global Projects, Hypnotherapy, Chiropractic, Oracle Clinical, Microsoft Office, SharePoint, Clinical Trial..., Pharmaceuticals, Medical Devices, Vaccines, CTMS, Pharmaceutical Industry, Clinical Monitoring, GCP, CRO, EDC, ICH-GCP, Clinical Development, Neurology, Clinical Operations, Protocol, Drug Development, Therapeutic Areas, Sop, Regulatory Submissions, Clinical Data Management, Clinical Study Design, SOP, Oncology, Life Sciences
Education
Hypnosis Motivation Institute 2011 — 2012
Certified Hypnotherapist, Hypnotherapy
New York College of Chiropractic 1991 — 1992
C.C.S.P, Chiropractic Sports Physician
Logan College of Chiropractic, Missouri 1987 — 1990
Doctor of Chiropractic, Chiropractic
Logan University 1987 — 1990
Doctor Of Chiropractic, Health Sciences
Logan College of Chiropractic, Missouri 1987 — 1988
B.Sc, Human Biology
State University of New York at Albany 1983 — 1987
B.A, Psychology
BioMarin Pharmaceutical Inc. May 2014 - Present
Genentech, Inc. June 2013 - December 2013
Theravance, Inc. March 2013 - May 2013
Janssen R&D (started at Scios then Alza then Centocor under Johnson and Johnson) October 2004 - September 2012
PPD Development August 2002 - September 2004
Allergan 2001 - 2002
Pharmacia (started with Searle) 1990 - 2001
Skills
Clinical Trials, CTMS, Pharmaceutical Industry, Oncology, GCP, Clinical Development, Clinical Research, Diabetes, CRO, EDC, Rheumatology, Immunology, Endocrinology, Infectious Diseases, Urology, Dermatology, Sop, Protocol, Biotechnology, Project Management, Regulatory Submissions, Regulatory Affairs, Pharmacovigilance, 21 CFR Part 11, FDA, Therapeutic Areas, Drug Development, Medical Affairs
Education
Governors State University 1985 — 1988
Bachelor's of Health Administration, Health Administration
R J Daley College 1982 — 1984
Associate of Applied Science (AAS), Pre-Pharmacy
Novella Clinical, Inc. 2013 - Present
INC Research, Inc August 2008 - August 2011
Kendle International August 2002 - August 2008
INC Research, Inc November 2001 - August 2002
PAREXEL June 2001 - November 2001
PPD Development February 1998 - May 2001
Skills
Sop, Clinical Data Management, Data Management, CTMS, CRO, Clinical Research, Inform, Oracle Clinical, Software Documentation, CRF design, Databases, Quality Assurance, Protocol, ICH-GCP, GCP, Pharmaceutical Industry, Clinical Trials, EDC, Data Validation, 21 CFR Part 11, CDISC, Clinical Development
Education
Elizabeth City State University 1990 — 1994
BS, Accounting
Contracted/Independent Clinical Resaerch Associate July 2012 - Present
King's Daughters Clinic May 2010 - August 2012
ICON Clinical Research February 2008 - March 2009
Pharma Services July 2007 - January 2008
INC Clinical Research October 2006 - July 2007
PPD Development August 2005 - October 2006
Silpada Designs 2005 - 2006
Grace Lutheran Church, Child Care January 2005 - April 2005
Scott & White Hospital October 2000 - May 2004
Gap Inc January 1998 - January 2001
Skills
Clinical Research, Clinical Trials, CTMS, Clinical Development, EDC, Oncology, Healthcare, ICH-GCP, Clinical Monitoring, GCP, Infectious Diseases, Regulatory Affairs, Regulatory Submissions, Therapeutic Areas, Sop, Pharmaceutical Industry, Trial Management, Protocol, CRO, Patient Recruitment, Clinical Operations, Clinical Data Management, IRB, Oracle Clinical, Pharmacovigilance, Biotechnology, CRF design, Medical Writing, Medical Devices, FDA, SOP
Education
University of Mary Hardin-Baylor 1999 — 2001
Bachelor, History, Kinesiology, and Secondary Educ.
University of North Texas 1997 — 1999
Killeen High School 1993 — 1995
PPD January 2015 - Present
PPD October 2013 - December 2014
PPD development November 2008 - October 2013
Covance Laboratories 2006 - 2008
Covance Laboratories 2005 - 2006
Covance Laboratories 2005 - 2005
Covance Laboratories 2002 - 2005
PPD 1999 - 2002
PPD 1997 - 1999
PPD 1996 - 1997
Skills
CRO, 21 CFR Part 11, GLP, FDA, GMP, Pharmaceutical Industry, CAPA, GCP, OECD, MHLW, HPLC, LC-MS, GC-MS, Analytical Chemistry, Solid Phase Extraction, Cross-functional Team..., Communication Skills, Organization &..., Sop, Quality Assurance, Validation, Bioanalysis, Laboratory, Chromatography, Regulatory Submissions, Regulatory Affairs, UV/Vis, Mass Spectrometry, Quality Auditing, GLPs, Analytical Method..., ICH guidelines, SOP development, Chemistry, SOP, Biotechnology, Quality Control, Life Sciences, Drug Development, Biopharmaceuticals, Clinical Trials, LIMS
Education
University of Wisconsin-Madison 1991 — 1996
BS in Chemistry, Chemistry
Milwaukee School of Engineering 1990 — 1991
Benchmark Research May 2001 - Present
PPD Development 1997 - 2001
Vandenberg Ambulance 1990 - 1993
Skills
CRO, Oncology
Education
Christ Hospital EMT-P
Paramedic
Moraine Valley Community College
Paramedic
Pfizer Pharmaceuticals May 2005 - Present
Wyeth May 2005 - August 2010
PPD Development 1999 - 2005
Children's Hospital of Pittsburgh 1996 - 1999
Skills
Clinical Trials, CTMS, Clinical Development, Drug Development, GCP, Pharmaceutical Industry, Regulatory Submissions, Vaccines, Oncology, CRO, Clinical Monitoring, ICH-GCP, Infectious Diseases, Biotechnology, Protocol, Pharmacovigilance, Clinical Research, Sop, Regulatory Affairs, Therapeutic Areas, Neurology, IND, EDC, Biopharmaceuticals, Lifesciences, Cardiology, 21 CFR Part 11, GLP, GMP, Pharmacology, FDA, Immunology, Medical Writing, Market Access, Drug Discovery, Validation, Medical Affairs, Pharmaceutics, Dermatology, Diabetes, Clinical Operations, Clinical Data Management, Neuroscience, Regulatory Requirements, Biomarkers, Biologics, Clinical Study Design, Pharmacokinetics, Change Control, Cross-functional Team...
Education
St. Francis University 1992 — 1996
BS, Biology, Magna Cum Laude
Merck November 2009 - Present
Schering Plough Research Institute May 2006 - November 2009
ICON Clinical Research April 2003 - May 2006
PPD Development October 2001 - April 2003
Skills
CTMS, Clinical Monitoring, CRO, Clinical Trials, GCP, EDC, ICH-GCP, Therapeutic Areas, Oncology, Clinical Development, Infectious Diseases, Clinical Research, Clinical Data Management, Pharmaceutical Industry, Oracle Clinical, Pharmacovigilance, Inform, Trial Management, Patient Recruitment, Clinical Operations, Vaccines, Protocol, Regulatory Submissions, Clinical Research...
Education
The University of Texas Medical Branch at Galveston 1996 — 1998
Bachelor of Science
Hearthstone Health and Fitness April 2012 - January 2014
World Instructor Training Schools August 2008 - May 2012
Charlottesville Parks and Recreation August 2011 - April 2012
Smith Aquatic and Fitness Center August 2011 - April 2012
Best In Health Personal Training/Health Promotion May 2008 - April 2012
University of Virginia Medical Center June 2008 - January 2012
University of Virginia Intramural Recreation Sports December 2009 - December 2010
University of Virginia Medical Center August 2003 - August 2007
University of Virginia Recreational Sports Program August 2003 - August 2007
PPD Development December 2002 - May 2003
Skills
Health, Fitness, Kinesiology, Wellness, Exercise Physiology, running, Running, Strength Training, Sports, Exercise Prescription, Personal Training, Health Promotion, Public Health, Health Education, Healthcare, Nutrition, Athletics, Treatment, Weight, Rehabilitation, Diabetes, Hospitals, Cpr Certified, Fitness Training, Wellness Coaching, Injury Prevention, Clinical Research, Rehabilitation..., Strength & Conditioning, Operant Conditioning, Weight Training, Sports Nutrition, Nutritional Counseling, Functional Training, Athletic Training, Sports Medicine, Stretching, Physical Therapy, Lifestyle Coaching, Biomechanics, Nutrition Education, Fitness Instruction, Endurance, Employee Wellness, Fitness Consulting, Cardio, Yoga, Group Training, Lifestyle, Cardiac Rehabilitation
Education
Chesapeake Community College 2013 — 2014
Associate's degree, Registered Nursing/Registered Nurse
University of Virginia School of Nursing 2007 — 2010
Ball State University 1997 — 1999
MS, Exercise Physiology/Adult Physical Fitness
Ohio Northern University 1993 — 1997
BS, Biology
PAREXEL May 2012 - Present
ReSearch Pharmaceutical Services May 2011 - May 2012
Alpha Professional Resources July 2010 - May 2011
Quintiles June 2004 - July 2010
PPD Development January 2001 - June 2004
American Social Health Association 1986 - 1996
Education
Cary Senior High
North Carolina State University
ACTELION CLINICAL OPERATIONS June 2011 - Present
Actelion Clinical Research February 2005 - June 2011
Actelion January 2001 - February 2005
HESPERION USA, INC January 2001 - December 2002
HESPERION USA, INC June 2000 - January 2001
PPD DEVELOPMENT January 1998 - June 2000
PPD DEVELOPMENT January 1997 - January 1998
PPD DEVELOPMENT January 1996 - January 1997
Skills
Clinical Trials, Clinical Trial..., GCP, Clinical Research, Clinical Monitoring, Clinical Development, ICH-GCP, Pediatrics, Biotechnology, Pulmonology, Research, CTMS, Clinical Study Design, FDA, Protocol, Sop
Education
University of North Carolina at Greensboro
BA, Sociology
NC State University 1989 — 1991
BA, Criminal Justice / Sociology
Foremost Farms USA March 2010 - Present
BioCascade (Contract) February 2009 - February 2010
TDX Power Inc, (Contract) March 2008 - October 2008
PPD DEVELOPMENT August 2006 - March 2008
Fend-All, Inc (Contract) March 2004 - March 2006
KJF COMPLIANCE May 1999 - March 2004
Tetrionics, Inc. February 1995 - March 1999
Clasen Quality Coatings August 1990 - February 1995
The Swiss Colony June 1986 - March 1990
Skills
cGMP, Regulatory Strategy, SPC, FDA, Quality Systems, ISO, CAPA, Auditing, Quality Assurance, Six Sigma, GMP, Process Validation, Quality Auditing, Root Cause Analysis, Supplier Quality, Validation, HACCP, Change Control, SOP, ISO 22000, Complaint Handling, 21 CFR Part 11, LIMS, Food, Regulatory Affairs, Food Safety, Pharmaceuticals, Documentation, Problem Solving, Document Management, Internal Audit, GxP, Change Management, Regulatory Submissions, ISO standards, Supplier Audits, ISO 17025, Supply Chain, Microsoft Office, SQF, Quality System
Education
University of Wisconsin-Madison 1983 — 1986
BS
Madison Area Technical College 1971 — 1973
Associate Degree
PPD March 2011 - Present
PPD Development February 2009 - March 2011
Campbell University April 2010 - July 2010
PPD Development July 2006 - December 2008
ACC Staffing December 2005 - July 2006
Hospira January 2005 - December 2005
Skills
Technical Writing, Research, FDA, Chemistry, GMP, GLP, HPLC, Analytical Chemistry, LIMS, Regulatory Affairs, Chromatography, Laboratory, SOP, Clinical Development, Biotechnology, Pharmaceutical Industry
Education
Campbell University 2007 — 2010
M.S, Clinical Research
North Carolina State University 2001 — 2004
B.S, Biology
Covance December 2013 - Present
Covance January 2012 - December 2013
PPD Development February 2006 - December 2011
Skills
Central Laboratory, CRO, Pharmaceutical Industry, Clinical Trials, Drug Development, CAP/CLIA, GCP, cGMP, Product Development, Method Development, Small Molecule Analysis, Inhalation Analysis, Stability Studies, Proposal Writing, Global Drug Development, Sales Presentations, Salesforce.com, SOP, Early Clinical..., Protocol Writing, Client Service Oriented, RFI, RFP Design, RFP Generation, Skin Care, Aesthetics, Skin Care Products, CTMS, GMP, Biopharmaceuticals, Sop, Client Services, Therapeutic Areas, Clinical Development, Life Sciences, Biotechnology
Education
California State University-Bakersfield 2002 — 2005
Bachelor of Science, Biology
Southern Oregon University 2002 — 2002
Bachelor of Science, Biology
Carroll University
Blue Cross and Blue Shield of North Carolina 2004 - Present
PPD June 1998 - October 2004
PPD Development June 1999 - May 2004
Skills
Health Insurance, Process Improvement, Insurance, Vendor Management, Team Building, Training, SharePoint, Program Management, Leadership, Budgets, Business Analysis, HIPAA, Project Management, Visio, •Strong teamwork,..., •Flexible, able to..., •Strong working..., •Able to keep..., Microsoft Office, Customer Service
Education
University of Phoenix 2012 — 2016
Bachelor's Degree, Business Administration and Management, General
AstraZeneca July 2014 - Present
INC Research October 2013 - July 2014
inVentiv Health Clinical August 2011 - October 2013
Diversified Research Inc. February 2011 - August 2011
GlaxoSmithKline Biologicals August 2010 - January 2011
Ockham Development Group (an ASG Company) October 2006 - December 2009
Wyeth February 2005 - September 2006
AstraZeneca February 2004 - February 2005
PPD DEVELOPMENT January 2004 - January 2005
WYETH LABORATORIES January 1997 - January 2003
Skills
Oncology, Cardiology, Gastroenterology, Therapeutic Areas, FDA, Clinical Research, Sop, Clinical Trials, Protocol, Pharmacovigilance, EDC, Data Management, CRO, ICH-GCP, Diabetes, Neurology, CTMS, Clinical Monitoring, Lifesciences, Biotechnology, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Medical Devices, Clinical Data Management, GCP, Dermatology, Drug Development, Vaccines, Neuroscience, SOP, Life Sciences
Education
Kutztown University of Pennsylvania
B.S
The Law Offices of Mark T. McCullough, PLLC April 2012 - September 2015
Durham County District Attorney's Office March 2008 - March 2012
Moore County DA's Office October 2007 - March 2008
PPD Development February 2002 - July 2004
Orange County North Carolina June 1989 - June 1999
Skills
Litigation, Criminal Law, Legal Writing, Legal Research, Constitutional Law, Negotiations, Medical Records, Medical Terminology, Clinical Trials, Emergency Medicine, Leadership, Supervision of Personnel, Negotiation, Public Speaking, Microsoft Word, Criminal Defense, Management, Policy, Criminal Justice, Courts, Appeals, Trials, Mediation, Supervision Of Personnel, Civil Litigation, Trial Practice, Hearings, Legal Assistance
Education
Campbell University, Norman Adrian Wiggins School of Law 2004 — 2007
JD, Law
University of North Carolina at Chapel Hill 1996 — 2001
B.A., Political Science and History
Durham Technical Community College 1989 — 1991
Certification, Emergency Medical Technology/Technician (EMT Paramedic)
Orange High School 1986 — 1989
Diploma, General Education
PAREXEL February 2012 - Present
INC Research October 2010 - February 2012
PPD Development May 2006 - October 2010
Village of July 2001 - May 2006
American Tower Corporation May 2000 - May 2001
Carteret County Planning Department May 1999 - May 2000
Auto Specialty Company August 1993 - May 1999
US Army November 1990 - May 1993
Skills
Process Improvement, Clinical Trials, Proposal Writing, Strategy, Management, Analysis, Leadership, Training, Project Planning, Business Development, Negotiation, New Business Development, Sales, Sop, Biotechnology, CRO, Human Resources, Policy, Cross-functional Team..., Pharmaceutical Industry, CTMS, GCP
Education
University of North Carolina at Wilmington 2003 — 2005
Master of Business Administration (MBA)
East Carolina University 1993 — 1999
Bachelor of Science, Urban and Regional Planning
ITT Technical Institute September 2009 - Present
Madison Area Technical College August 2001 - Present
Tetrionics February 2001 - August 2001
PPD Development 1998 - 1999
Alpharma 1988 - 1998
Skills
HPLC, IC, Writing, R&D, Teaching, UV-Vis, Chemistry, Life Sciences, Mathematics, Statistics, Science, UV/Vis, Training, Analytical Chemistry, Instructional Design, Spectroscopy, Lifesciences, Laboratory, Validation, Purification, FTIR, Chromatography, Microsoft Office, Research
Education
Governors State University 1989 — 1994
MS, Analytical Chemistry
Governors State University 1986 — 1988
Bachelor’s Degree, Chemistry, 3.82 G.P.A. - Cumulative of my Junior & Senior Years
South Suburban College 1982 — 1984
Associate's Degree, Chemistry, 3.0 gpa
RJ Reynolds July 2010 - Present
Pharmaceutical Regulatory and Product Development Consulting April 2008 - June 2010
Pharma Form March 2007 - April 2008
Sapphire Therapeutics September 2005 - February 2007
Akros Pharma. Inc. January 2001 - March 2005
PPD Development April 1997 - January 2001
Knoll Pharmaceutical Company December 1990 - April 1997
Baylor College of Medicine September 1985 - December 1990
Education
University of Houston 1982 — 1986
Ph.D., Pharmacology
University of Houston 1979 — 1981
MS
Jiwaji University 1972 — 1973
MSc, Chemistry
Jiwaji University 1968 — 1971
BSc, Biology/ Chemistry
Quintiles May 2015 - Present
Quintiles June 2014 - Present
Quintiles Transnational August 2010 - June 2014
ReSearch Pharmaceutical Services April 2008 - July 2010
PPD Mexico February 2006 - April 2008
PPD Mexico April 2005 - February 2006
PPD Development August 2004 - April 2005
PPD Development Mexico February 2004 - August 2004
PPD Development Mexico August 2003 - January 2004
PPD Development Mexico January 2003 - July 2003
Skills
Clinical Trials, Clinical Monitoring, Clinical Research, Clinical Operations, ICH-GCP, Protocol, Therapeutic Areas, Diabetes, Biotechnology, GCP, CRO, CTMS, Clinical Development, Data Management, EDC
Education
Nottingham Trent University/ E.A.E./ U.P.C, Barcelona, Spain 2001 — 2002
MBA, Masters in Business Administration
Universidad Iberoamericana, Ciudad de México 1996 — 2001
BSc, Chemical Engineering
Mexico
Napier Realtors ERA August 2014 - Present
PPD Development 2011 - May 2014
PPD November 2004 - September 2011
PPD January 2001 - November 2004
PPD August 1999 - January 2001
VA Department of Health 1996 - 1999
Ethyl Corporation 1993 - 1996
Skills
Clinical Trials, Biostatistics, SAS, Validation, Data Management, Data Validation, Programming, CRO, SAS programming, Clinical Research, EDC, Oncology, Clinical Data Management, FDA, GCP, CDISC, Clinical Development, Pharmaceutical Industry, Oracle Clinical, CTMS
Education
ECPI 1992 — 1994
Programming, Computer Science
East Carolina University 1989 — 1992
Fair Housing Center of Southeastern Michigan September 2013 - Present
Lakeshore Legal Aid July 2010 - September 2013
Legal Services of South Central Michigan January 2010 - June 2010
Lakeshore Legal Aid July 2008 - December 2009
Arapahoe County District Court July 2007 - November 2007
Office of the Colorado State Public Defender August 2006 - October 2006
PPD Development September 2002 - June 2003
Skills
Criminal Law, Family Law, Courts, Legal Issues, Trials, Legal Assistance
Education
University of Denver - Sturm College of Law 2003 — 2006
JD
Emory University 1998 — 2001
B.A., History, Sociology
RPS, Inc. October 2007 - Present
Altana Pharma, A Nycomed Company November 2004 - October 2007
PPD Development February 2003 - November 2004
Education
University of New Orleans 1997 — 2002
US Biotest November 2010 - Present
Fulcrum Pharma Developments May 2000 - November 2010
PPD Development 1992 - 2000
Skills
Oncology, GMP, R&D, Biopharmaceuticals, Program Management, Molecular Biology, Drug Development, IND, Regulatory Submissions, Pharmacology, Pharmaceutical Industry, Clinical Development, Clinical Research, Clinical Study Design, Drug Discovery, GCP, CTMS, Biotechnology, Lifesciences, Regulatory Affairs, CRO, Immunology, EDC, Clinical Trials, ICH-GCP, FDA
Education
St Mary College
Texas A&M University
Shimadzu Scientific Instruments June 2014 - Present
RxBio April 2013 - June 2014
Advion Biosciences May 2003 - April 2013
Tandem Labs 2007 - 2008
PPD Development January 2000 - April 2003
Skills
Bioanalysis, Chromatography, Mass Spectrometry, LC-MS, HPLC, Analytical Chemistry, Proteomics
Education
Randolph-Macon College 1995 — 1999
Austin Community College 2010 - Present
Melissa Noel, Consultant 2001 - Present
Ingenix International 1999 - 2000
Worldwide Clinical Trials 1998 - 1999
Clinicor, Inc 1997 - 1998
PPD Development 1996 - 1997
PPD Pharmaco 1994 - 1996
Pharmaco LSR 1991 - 1994
Sherikon, Inc 1988 - 1990
EER Systems 1988 - 1989
Skills
Teaching, Higher Education, Data Analysis, Computer System..., Clinical Data Management, Clinical Research, Data Management, Biotechnology
Education
North Carolina State University - College of Management 1986 — 1988
Master of Economics
University of Delaware 1977 — 1980
B.A.
Amgen December 2009 - Present
ICON Development Solutions August 2008 - December 2009
ICON Development Solutions May 2007 - July 2008
ICON Development Solutions November 2005 - May 2007
ICON Development Solutions February 2004 - January 2006
First Health November 2002 - February 2004
Insmed May 2001 - September 2002
PPD Development January 2000 - May 2001
PPD Development July 1997 - January 2000
Skills
Clinical Trials, SAS, Clinical Research, Statistical Programming, CDISC, CRO, Data Management, Oncology, Clinical Data Management, Biostatistics, Validation, Biotechnology, Pharmaceuticals, Oracle Clinical, Data Analysis, Pharmaceutical Industry, GCP, CTMS, Clinical Development, EDC, Regulatory Submissions, 21 CFR Part 11, Protocol, FDA, SAS programming
Education
Virginia Commonwealth University - School of Business 1993 — 1995
Post Bacheloriate, Business Information Systems
Radford University 1985 — 1990
Bachelor of Science, Fine Art and Graphic Design
Amgen July 2011 - Present
Amgen October 2004 - August 2011
PPD Development September 2001 - October 2004
Roche Pharmaceuticals September 1999 - June 2001
Skills
Oncology, Clinical Trials, CRO, CTMS, Clinical Research, Clinical Development, Biotechnology, Drug Development, Pharmaceutical Industry, Microsoft Office, Neuroscience, Osteoporosis
Education
University of California, Davis 1993 — 1998
PPD Development November 2001 - June 2015
Skills
Cross-functional Team..., Customer Service, Quality Assurance
Education
B.S. Biology
The University of Texas at Austin
Bachelor of Science (B.S.), Biology/Zoology
Lubbock ISD June 2013 - Present
West Texas A&M University August 2012 - August 2013
IMPACT Futures December 2011 - January 2013
VALIC 2009 - 2011
Amarillo Center for Clinical Research 2003 - 2007
PPD Development 2000 - 2004
Skills
Clinical Research, Psychology, Community Outreach, Program Development, Microsoft Office, PowerPoint, Data Analysis, Leadership Development, Training, Microsoft Excel, Statistics, Staff Development, Program Evaluation, Curriculum Design, EDC, Event Planning, Fundraising, Grant Writing, Healthcare, Higher Education, Research, Teaching, Curriculum Development, E-Learning, Nonprofits
Education
Texas Tech University 2015 — 2018
PhD, Educational Psychology/LSSP
West Texas A & M University 2011 — 2014
Specialist in School Psychology (SSP), Specialist in School Psychology Program
West Texas A&M University 2007 — 2011
BS, Psychology
Wayland Baptist University 1997 — 1999
Pre-Medicine/Pre-Medical Studies
Pharm-Olam International October 2014 - Present
Pharm-Olam International May 2013 - Present
S. Research June 2012 - May 2013
Premier Research Group April 2010 - March 2012
PharmaNet May 2007 - March 2010
i3 Research 2005 - 2007
PPD Development 1998 - 2005
ManTech 1990 - 1994
Skills
Oracle Clinical, EDC, Clinical Data Management, CDISC, CRF design, CRO, GCP, Clinical Trials, Data Management, Inform, CTMS, Oncology, Clinical Development, 21 CFR Part 11, Clinical Monitoring, ICH-GCP, Pharmaceutical Industry, Protocol, Sop, Therapeutic Areas
Education
North Carolina State University 1984 — 1988
BS, Biological Sciences
Merck April 2010 - Present
Schering-Plough Research Institute August 2005 - April 2010
PPD Development March 2002 - July 2005
PRA International March 2000 - March 2002
Education
University of Central Missouri 1994 — 2000
Biology
Everest Clinical Research Services Inc. February 2014 - Present
Everest Clinical Research Services Inc. February 2013 - January 2014
Warner Chilcott August 2010 - January 2013
Merck November 2009 - August 2010
Schering-Plough November 2007 - November 2009
Organon USA November 2003 - November 2007
PPD Development April 2003 - September 2003
PPD Development June 1999 - March 2003
TEXAS A&M UNIVERSITY January 1999 - May 1999
Skills
SAS, Statistics, Clinical Trials, Clinical Development, Protocol Development, Analysis, Biostatistics, Statistical Programming, Data Analysis, Data Mining, Statistical Modeling, CRO, Protocol, Oncology, Pharmaceutical Industry, Regulatory Submissions, GCP, CDISC, Clinical Data Management, EDC, Clinical Study Design, Drug Development, FDA, Data Management, CTMS, Medical Writing, Clinical Research, 21 CFR Part 11, SAS programming, SDTM, Oracle Clinical, Survival Analysis, Therapeutic Areas, Pharmacovigilance, Validation, ICH-GCP, Biotechnology, Regulatory Affairs, Pharmacokinetics, Neuroscience, CRF design, GxP, Lifesciences, Pharmacology, Infectious Diseases, Computer System..., R, Biomarkers, Epidemiology, Inform
Education
Texas A&M University 1994 — 1999
Ph.D., Statistics
Texas A&M University 1992 — 1994
MS, Statistics
National Cheng Kung University 1985 — 1989
BS, Mathematics
American City Business Journals November 2011 - Present
American City Business Journals 2010 - 2013
American City Business Journals 2010 - 2013
Apple Inc. December 2010 - November 2011
PPD Development April 2002 - July 2009
PPD Development April 2005 - January 2009
PPD 2002 - 2009
PPD Development April 2004 - April 2005
PPD Development April 2002 - April 2004
EDS January 2000 - January 2001
Skills
System Administration, Software Documentation, MySQL, PHP, CSS, Troubleshooting, SQL, Active Directory, Linux, Social Media Marketing, Windows, SharePoint, Help Desk Support, HTML, Access, Technical Support, Web Development, JavaScript, Unix, Social Media, Project Management
Education
Mount Olive College 1992 — 1996
BS, Recreation and Leisure Studies (emphasis on Therapeutic Recreation)
ECPI Technical College
Program, the Information Technology Field
Novella Clinical, Inc. (A Quintiles Company) August 2014 - Present
Quintiles October 2012 - July 2014
ClearTrial LLC August 2011 - October 2012
Covance Inc January 2011 - July 2011
Covance Inc July 2006 - January 2011
Covance Clinical & Periapproval Services Ltd June 2005 - July 2006
Kendle International April 2004 - June 2005
Mills & Reeve September 2003 - March 2004
PPD Development April 2002 - September 2003
UUNET, a Worldcom company November 1999 - April 2002
Skills
Contract Negotiation, Budgets, Forecasting, Strategic Planning, Competitive Analysis, Business Development, Strategy, Management, Process Improvement, Analysis, Project Management, Proposal Writing, CRO, Procurement, Leadership, Training, Negotiation, Team Building, Cross-functional Team...
Education
Oxford Brookes University 2002 — 2005
BSC, Applied Accounting
Association of Chartered Certified Accountants 2000 — 2005
Part II Qualified, Accounting
Cambridge Regional College
Diploma, Business and Finance
Hallux Inc. November 2014 - Present
Santen April 2012 - October 2014
Celtic Pharma July 2008 - June 2012
Alexion Pharmaceuticals August 2005 - July 2008
Protein Sciences Corporation July 2004 - July 2005
PPD Development 1997 - 2004
Skills
Clinical Development
Education
University of Cape Town 1995 — 1997
MBA
Utrecht University 1980 — 1989
MD, Medicine
Bogerman School Houten
Dr FH de Bruijnelyceum
Bristol-Myers Squibb January 2015 - Present
GlaxoSmithKline April 2005 - January 2015
Kelly Scientific November 2004 - April 2005
Kelly Scientific August 2004 - September 2004
Kelly Scientific July 2002 - July 2003
PPD DEVELOPMENT December 2000 - June 2002
ASTRAZENECA February 2000 - October 2000
UNIVERSITY OF PENNSYLVANIA MEDICAL CENTER January 1996 - January 2000
UNIVERSITY OF PENNSYLVANIA MEDICAL CENTER January 1993 - December 1995
American Association of Medical Assistants 1988 - 1993
Skills
Clinical Trials, GCP, Clinical Development, Pharmaceutical Industry, Clinical Research, Clinical Data Management, Drug Development, Oncology, ICH-GCP, Clinical Operations, FDA, Biotechnology, Medical Affairs, Protocol, Infectious Diseases, Contracts, CRO
Education
La Salle University - School of Business Administration 1989 — 1992
Bachelor of Science, Business Management
Fisher College 1986 — 1988
Associate of Science, Medical Assisting
PPD October 2011 - Present
PPD Development April 2006 - October 2011
PPD May 2004 - April 2006
PPD November 1999 - May 2004
Tyrex, Inc March 1999 - November 1999
Aera Manufacturing March 1998 - February 1999
Powerlogix, R&D December 1996 - March 1998
Atlanta Community Food Bank June 1994 - December 1996
Skills
Strategic Planning, Pharmaceutical Industry, Financial Audits, Change Management, US GAAP, Finance, Management, Accounting, Auditing, Internal Audit, Analysis, Sarbanes-Oxley Act, Mergers & Acquisitions, Account Reconciliation, Financial Reporting, Business Process..., Cross-functional Team..., Budgets, Clinical Trials, CRO
Education
University of Texas 1988 — 1993
Bachelor of Business Administration (B.B.A.), Accounting and Finance
Stephen F. Austin State University 1986 — 1987
PPD Development February 2008 - Present
Skills
CRO, FDA, Clinical Development, Pharmaceutical Industry, Drug Development, Regulatory Affairs, Oncology, Lifesciences, Technology Transfer, Biotechnology, Clinical Trials, GLP, Drug Discovery
Education
Lewis University 1992 — 1996
MBA, Finance
Lewis University 1987 — 1991
BS, Biology
Kinetic Concepts Inc. October 2007 - Present
Kinetic Concepts Inc. November 2003 - Present
PPD Development September 2002 - November 2003
Skills
SAS programming, Biostatistics, Clinical Trials, SAS, Statistics, Clinical Data Management, Clinical Research, Validation, GCP, Clinical Development, Data Management, FDA, Survival Analysis, Clinical Study Design, Medical Devices, Data Analysis, R, Quality Assurance, 21 CFR Part 11, Design of Experiments, EDC, CRO, CAPA, CTMS, Regulatory Submissions, Protocol
Education
Texas State University 1990 — 1993
M.S., Biostatistics
Solid company in San Diego area Clinical Data Analyst IIResearchPoint2005 - 2011
Keller Williams Realty 2004 - 2011
PPD Development 2003 - 2004
PPD 2001 - 2003
PPD 2000 - 2001
PPD 1994 - 2000
PPD 1992 - 1994
Skills
Professional Healthcare..., Proficient in Microsoft..., Good rapport with..., Customer Service..., Detail Orientation, Data Analysis experience, Policy and procedure..., Task Organization, Real Estate experience
Education
Texas A&M University-Kingsville
BA, Major in Biology
Quintiles International September 2009 - Present
PRA International April 2006 - May 2009
SFBCI (Kennett Square office) March 2005 - May 2006
PPD Development November 2003 - July 2004
Synteract, Incorporated 2001 - 2003
Gen-Probe, Incorporated 1993 - 2001
Gen-Probe 1985 - 2001
Skills
Clinical Trials, Clinical Research, CRO, Clinical Data Management, Regulatory Affairs, Infectious Diseases, Clinical Monitoring, Therapeutic Areas, Vaccines, FDA, Medical Devices
Education
San Diego State University-California State University
B.S., Biology, Molecular Biology
Brunswick County Schools August 2010 - Present
Tanger Outlet Mall November 2009 - August 2010
Statistics and Data Corporation August 2008 - November 2008
Applied Solutions Group (ASG), IncMyriad Pharmaceuticals May 2008 - August 2008
PPD Development August 2005 - May 2008
Quintiles-Contract June 2004 - August 2005
PPD Development August 2001 - May 2004
Applied Clinical Concepts October 1999 - April 2001
Duke Clinical Research Institute, Duke University May 1999 - July 1999
Butler Clinical Research February 1999 - March 1999
Skills
Molecular Biology, PCR, Western Blotting, Cell Culture, Biochemistry, Microscopy, Cell Biology, Genetics, Molecular Cloning, ELISA, Clinical Research, EDC, Oncology, Infectious Diseases
Education
Shaw University 1992 — 1998
Bachelor of Science (B.S.), Biology/Biological Sciences, General
West Brunswick High School 1988 — 1992
Diploma
Shaw University
Bachelor of Science, Biology
Fresenius Kabi August 2007 - Present
Baxter August 2003 - May 2007
Pfizer/Pharmacia February 2002 - August 2003
PPD Development July 1999 - January 2002
Skills
HPLC, Analytical Chemistry, LC-MS, Validation, Quality System, GMP, CAPA, Design of Experiments, Medical Devices, Gas Chromatography, Biotechnology, Polymers, FDA, R&D, V&V, Chemistry, GLP, Laboratory, Pharmaceutics, Chromatography, FTIR, Technology Transfer, GC-MS
Education
Sun Yat-Sen University
B.S.
Sun Yat-Sen University
Master of Science (MS)
University of Louisville
Master of Science (MS)
INC Research April 2012 - Present
INC Research January 2011 - April 2012
MetaClin Research, Inc. July 2006 - February 2011
PPD Development December 2004 - July 2006
Austin Cardiovascular Associates September 2003 - December 2004
PPD Development January 2002 - August 2003
Skills
Clinical Trials, Protocol, Clinical Research
Education
The University of Texas at Austin 1997 — 2001
Bachelor of Science, Kinesiology
PPD May 2015 - Present
Quintiles November 2010 - May 2015
Quintiles June 2007 - October 2010
Unifour Medical Research September 2006 - June 2007
MedARK Clinical Research July 2006 - August 2006
Metrolina Medical Research September 2001 - July 2006
PPD Development March 2000 - July 2001
Experimental Pathology Laboratories, Inc. May 1999 - March 2000
University of North Carolina School of Medicine May 1995 - July 1995
Skills
Clinical Trials, EDC, Protocol, ICH-GCP, CTMS, GCP, CRO, Study Coordination, Medical Terminology, Endocrinology, Therapeutic Areas, IRB, Data Management, Patient Recruitment, Regulatory Submissions, Clinical Research, Trial Management, Medidata, Infectious Diseases, Inform, Sop, Clinical Development, Clinical Data Management, Oncology, Diabetes, Cardiology, ICH guidelines, Rheumatoid Arthritis, Hypertension, Asthma, Rheumatology, Gastroenterology, Oracle Clinical, Pharmaceutical Industry, Regulatory Requirements, FDA, Life Sciences, Drug Development, Clinical Operations, Employee Training, Site Selections, Site Initiation, Site Closure, Phase II, Phase III, Phase IV
Education
University of North Carolina School of Medicine 1994 — 1996
North Carolina State University 1990 — 1993
Bachelor of Science Degree, Zoology, Summa Cum Laude
ICON plc November 2012 - Present
MetaClin Research, Inc. October 2006 - November 2012
SCIREX Corporation 2005 - 2006
Radiant Research, Inc. 2002 - 2004
PPD Development 1991 - 2001
Skills
Phase I, EDC, Clinical Trial..., GCP, Phase II, Phase III, Phase IV, CRA, Research Project..., Phlebotomy, Lab Processing, Pharmacy Technician, Patient Recruitment, Technical Procedures, Clinical Trials, Clinical Research, CTMS, Regulatory Submissions, FDA, Neurology, Clinical Monitoring, ICH-GCP, Therapeutic Areas, Project Management, CRO, Clinical Research..., Pharmaceutical Industry, Protocol, Oncology
Education
Southwestern University Georgetown TX 1978 — 1979
Business, Management, Marketing, and Related Support Services
Angelo State University 1976 — 1978
Art/Music
American Home Companion June 2012 - Present
PRA International October 2011 - February 2012
ReSearch Pharmaceutical Services February 2008 - October 2011
Kendle International Inc. December 2005 - February 2008
INC Research September 2004 - October 2005
Quintiles INC. April 2004 - August 2004
PPD Development August 1999 - April 2004
Skills
GCP, Clinical Trials, Protocol, SOP, FDA, Clinical Research, Regulatory Requirements, Management, Mentoring, Team Leadership
Education
Independence University 2015 — 2017
Bachelor’s Degree, Respiratory Management
Independence University 2013 — 2014
Associate’s Degree, Respiratory Therapy, 3.67 GPA
Duke University Health System May 2013 - Present
PharmaNet/i3 March 2007 - May 2013
PPD Development December 2004 - February 2007
INC Research 2002 - 2004
Inveresk Research June 2001 - April 2002
Duke Image Analysis Lab (DIAL); Duke Dept of Radiology October 1999 - June 2001
Skills
EDC
Education
Duke University
BS, Biology, General