Halloran Consulting Group, Inc.
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Halloran Consulting Group, Inc. Employees
Halloran Consulting Group, Inc. December 2014 - Present
Halloran Consulting Group, Inc. August 2013 - December 2014
clinivation, Inc. February 2011 - August 2013
Skills
Leadership, Healthcare, Management, Strategy, Project Management, Process Improvement, Microsoft Office, Operations Management, Six Sigma, Healthcare Management, Pharmaceutical Industry, Program Management, Knowledge Management, Professional Services, Business Strategy, Strategic Planning, Cross-functional Team..., Data Analysis, Analysis, Team Leadership, Technology Integration, Team Building, Operational Execution, Networking, System Administration, 21 CFR Part 11
Education
Harvard School of Public Health
Executive Concentration
University of Massachusetts Boston
Master of Business Administration (MBA)
Massachusetts College of Pharmacy and Health Sciences
Bachelor of Science (B.Sc.)
Vericel Corporation October 2014 - Present
Halloran Consulting Group, Inc. December 2012 - October 2014
Covidien May 2012 - September 2012
Electric Boat December 2011 - January 2012
Lawrence and Memorial Hospital July 2011 - August 2011
Electric Boat May 2011 - August 2011
Pawcatuck Veterinary Clinic May 2011 - August 2011
Electric Boat May 2010 - August 2010
Skills
Labview, Biomedical Engineering, Design of Experiments, Solidworks, Root Cause Analysis, Matlab, Mechanical Testing, Engineering, Microsoft Office, Gap Analysis, Manufacturing, Testing, Quality System, Medical Devices, Program Management, Validation, R&D, Minitab, Sop, Process Engineering, Six Sigma, CAPA, ISO 13485, Cross-functional Team..., Quality Assurance, FDA, SPC, Process Simulation, GMP, Lean Manufacturing
Education
The University of Connecticut 2008 — 2012
Bachelor of Science, Biomedical Engineering, Biomaterials
Halloran Consulting Group, Inc. December 2014 - Present
Actavis August 2014 - December 2014
Forest Laboratories July 2013 - July 2014
Forest Laboratories November 2012 - June 2013
TIMI Study Group, BWH and Harvard Medical School October 2012 - January 2013
TIMI Study Group, BWH and Harvard Medical School January 2011 - October 2012
Harvard Clinical Research Institute October 2008 - January 2011
Whitman Law August 2007 - October 2008
Skills
Clinical Trials, Strategic Planning, Leadership, Project Management, Quality Assurance, Regulatory Submissions, Data Management, Pharmacovigilance, Medical Writing, Clinical Monitoring, Consulting, GCP, SOP, ICH-GCP, Protocol, Regulatory Affairs, Therapeutic Areas, Life Sciences, Management, CRO, CTMS, Research, Clinical Research, FDA, Lifesciences, Clinical Development, Drug Development, Clinical Data Management, EDC, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Cross-functional Team...
Education
Boston University
B.A.
Halloran Consulting Group, Inc. June 2013 - Present
Pfizer (Contractor) July 2007 - June 2013
GSK 2005 - 2007
Biogen Idec 2000 - 2005
State Street Research 1999 - 2000
Skills
Pain, Neurology, Clinical Trials, FDA, Regulatory Submissions, Clinical Trial..., CRO, Clinical Development, GCP, Pharmaceuticals, Clinical, Clinical Research, EDC, Phase I, Budget Management, R&D, Pharmaceutical Industry, Clinical Monitoring, Clinical Operations, Protocol, 21 CFR Part 11, Lifesciences, Neuroscience, Clinical Study Design, ICH-GCP, Drug Development, Clinical Data Management, Sop, Oncology, Pain Management, Biotechnology, Life Sciences, CTMS, SOP
Education
Meredith College 2005 — 2008
MBA, MBA
University of Iowa 1994 — 1999
Bachelor of Arts (B.A.), Psychology and Physical Studies
Halloran Consulting Group, Inc. January 2015 - Present
TUV Rheinland of North America November 2012 - January 2015
TUV Rheinland of North America September 2012 - January 2015
The Java Room May 2007 - September 2012
Skills
Bartending, French, Swimming, Customer Service, Coffee, German, Food Safety, Teamwork, Food, PowerPoint, English, Problem Solving, Microsoft Office, Microsoft Word, Microsoft Excel, SAP, Event Management, System Administration, International Business, International Marketing, Inventory Management, Market Research, Cooking, Leadership, Product Development, Marketing Strategy, Sales, Data Entry, Team Building, Sales Management, Operations Management, Management, Customer Satisfaction, Social Media, Lotus Notes, Outlook, Social Networking, New Business Development, Strategic Planning, Time Management, Logistics, Purchasing, Business Strategy, Account Management, Team Leadership, Marketing, Forecasting, Social Media Marketing, Program Management, Public Relations
Education
Southern New Hampshire University 2013 — 2015
Master of Business Administration (MBA), MBA
UMass Lowell 2007 — 2012
Bachelor's degree, Bachelor of Liberal Arts with concentrations in French and English
Shire Pharmaceuticals May 2014 - Present
Tremont Therapeutics Consulting, LLC May 2013 - May 2014
Halloran Consulting Group, Inc. March 2011 - May 2013
Tremont Therapeutics August 2009 - March 2011
Alnylam Pharmaceuticals July 2007 - August 2009
Novartis Institutes for BioMedical Research January 2006 - June 2007
Novartis Institutes for BioMedical Research January 2005 - January 2006
Broad Institute February 2002 - January 2005
University of California, San Francisco 1995 - 2001
Skills
Lifesciences, Biotechnology, Drug Development, Drug Discovery, Pharmaceutical Industry, Project Management, Genetics, Team Leadership, Leadership, GLP, Regulatory Affairs, Management, Clinical Development, FDA, Technology Transfer, Strategy, Cross Functional Team..., Validation, Commercialization, GMP, Cross-functional Team..., Clinical Trials, Molecular Biology, CRO, Analysis, Sop, R&D, Regulatory Submissions, Biopharmaceuticals, Oncology, GCP
Education
Project Management Institute 2007 — 2014
P.M.P.
University of California, San Francisco 1995 — 2001
Ph.D.
UNC-Chapel Hill 1991 — 1995
B.S.
CPC LLC July 2015 - Present
Halloran Consulting Group, Inc. December 2013 - June 2015
Connacht Peterson Consulting LLC August 2011 - November 2013
Eli Lilly / inVentiv Health Clinical (formerly i3 Research) April 2008 - August 2011
Eli Lilly / i3 Research FSP April 2007 - January 2008
ARS, Inc. January 2004 - February 2007
Skills
CTMS, Clinical Trials, Infectious Diseases, Dermatology, Clinical Monitoring, EDC, CRO, ICH-GCP, GCP, Clinical Data Management, Clinical Development, Regulatory Submissions, Medical Writing, Oncology, Trial Management, Diabetes, Neuroscience, Protocol, Inform, Regulatory Affairs, 21 CFR Part 11, Clinical Operations, IND, Data Management, Regulatory Requirements, Osteoporosis, Clinical Research..., GLP, IRB, CRF design, Clinical Research
Education
Boston College 2003 — 2004
MS, Liberal Arts
University of Connecticut 1999 — 2003
BA, Spanish, Political Science
Halloran Consulting Group, Inc. September 2015 - Present
Halloran Consulting Group, Inc. January 2015 - September 2015
FORUM Pharmaceuticals Inc. (Formerly EnVivo Pharmaceuticals) December 2012 - January 2015
FORUM Pharmaceuticals Inc. (Formerly EnVivo Pharmaceuticals, Inc.) July 2010 - December 2012
Dana Farber Cancer Institute 2010 - June 2010
Dana Farber Cancer Institute December 2008 - January 2010
Skills
Womens Collegiate..., Clinical Research, FDA, Protocol, Clinical Trials, Clinical Development, GCP, CTMS, Biotechnology, EDC, Pharmaceutical Industry, Lifesciences, CRO, Life Sciences, Regulatory Affairs, IND, Oncology
Education
University of New Hampshire 2002 — 2006
Bachelor of Science, Molecular and Cellular Developmental Biology
The Academy of Notre Dame 1998 — 2002
HS Diploma
Quantum Imaging LTD July 2015 - Present
Halloran Consulting Group, Inc. August 2013 - June 2015
Regenesis Biomedical, Inc. January 2012 - June 2013
Nanosphere, Inc. June 2005 - January 2012
Abbott Point of Care 2002 - 2005
Boston Scientific 1999 - 2002
Bio-Reg Associates 1995 - 1999
Skills
Medical Devices, FDA, Biotechnology, Pharmaceutical Industry, Lifesciences, Regulatory Affairs, Infectious Diseases, Clinical Development, Oncology, Clinical Research, CRO, Cardiology, Biochemistry, Assay Development, Immunoassays, Drug Discovery, Molecular Diagnostics, Genomics, Molecular Biology, Clinical Trials, Regulatory Submissions, Sop, Biomedical Engineering, Medical Affairs, Protocol, Urology, Medicine, Medical Diagnostics, Clinical Study Design, Healthcare, Cancer, Commercialization, Immunology, Genetics, Drug Development, Laboratory, Hematology, Biomarkers, Personalized Medicine, Hardware Diagnostics, Neurology, Translational Medicine, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill School of Medicine 1979 — 1985
MD, Medicine
Northwestern University 1975 — 1982
BS and MS, Biomedical Engineering
Merrimack Pharmaceuticals August 2015 - Present
Halloran Consulting Group, Inc. November 2014 - August 2015
Halloran Consulting Group, Inc. September 2009 - 2013
Boston University School of Management March 2008 - February 2009
Boston University 2007 - 2008
Boston University 2005 - 2007
Linklaters 2001 - 2003
Skills
Biotechnology, Market Research, Program Management, Lifesciences, Strategic Planning, New Technology..., Cross-functional Team..., Process Improvement, Leadership, Mergers & Acquisitions, Management, Training, Due Diligence, Analysis, Integration, Project Planning, Strategy, Consulting
Education
Boston University Questrom School of Business 2006 — 2010
MBA, Strategy & Business Analysis; Entrepreneurship
University of West Bohemia, Pilsen 1999 — 2004
Master of Law, Legal
Halloran Consulting Group, Inc. April 2015 - Present
Halloran Consulting Group, Inc. May 2014 - April 2015
Halloran Consulting Group, Inc. June 2013 - May 2014
451 Marketing January 2013 - April 2013
Hockomock Area YMCA August 2008 - 2013
Hockomock Area YMCA June 2012 - August 2012
Skills
Social Networking, Marketing
Education
Bryant University 2009 — 2013
Bachelor of Science in Business Administration, Marketing and Political Science
University College Cork 2013 — 2013
County Cork, Ireland, Study Abroad Program
Nipmuc Regional High School 2005 — 2009
Halloran Consulting Group, Inc. October 2014 - June 2015
Gelfand, Rennert & Feldman, LLP 2014 - 2014
Artist 2013 - 2014
Brook Venture Partners April 2011 - June 2012
William Gallagher Associates 2011 - 2011
Hondar House, Inc 2001 - 2010
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, Accounting, Social Media
Education
University of Massachusetts Boston 2007 — 2011
B.S.M, Finance
Clark Regulatory Solutions, LLC September 2015 - Present
Halloran Consulting Group, Inc. March 2011 - August 2015
Halloran Consulting Group, Inc. May 2012 - July 2014
Halloran Consulting Group, Inc. March 2011 - May 2012
Boston Scientific June 2008 - March 2011
Boston Scientific January 2006 - June 2008
Vivatone Hearing Systems 2003 - January 2006
Interventional Therapies November 1999 - January 2006
United States Surgical Corporation 1996 - 1998
Skills
Regulatory Affairs, Medical Devices, Quality Systems, Clinical Trials, Clinical, Life Sciences, Product Development, FDA, ISO 13485, CAPA, Pharmaceuticals, Oncology, Design Control, Clinical Research, Regulatory Submissions, GMP, Biotechnology, 510 K, Compliance, QSR, Clinical Development, Healthcare, Regulatory Strategy, Strategic Planning, Cardiology, PMA, CE marking, Auditing, Quality Auditing, Start-ups, GCP, Cross-functional Team..., ISO, Lifesciences, Quality Assurance, Quality System, Strategy, Commercialization, Computer System..., R&D, Validation, Sop, CRO, Regulatory Requirements, SOP, Pharmaceutical Industry, CTMS
Education
Eastern Connecticut State University 1992 — 1996
BS, Biology
University of Bridgeport
MS, Human Nutrition
Halloran Consulting Group, Inc. May 2010 - Present
Boston Scientific January 2007 - April 2010
aaiPharma 2000 - 2006
Brigham and Women's Hospital 1997 - 2000
Skills
Diabetes, Cardiology, Sop, CTMS, GCP, Quality System, Clinical Development, Clinical Trials, Line Management, FDA, Clinical Data Management, EDC, Oncology, Clinical Monitoring, Regulatory Affairs, Clinical Operations, Regulatory Submissions, Protocol, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Therapeutic Areas, SOP
Education
University of New Hampshire 1982 — 1986
Bachelor of Science (BS), Nursing
Halloran Consulting Group, Inc. January 2004 - Present
Antigenics 2001 - 2004
MTRA/AAI Labs 1999 - 2001
PAREXEL 1991 - 1999
Covance (formerly G.H. Besselar) 1990 - 1991
Skills
Clinical Development, Clinical Research, Clinical Trials, CRO, Biopharmaceuticals, Drug Development, 21 CFR Part 11, Quality Auditing, Clinical Operations, EDC, CTMS, GCP, Regulatory Affairs, quality management
Education
Boston University 1989 — 1991
Master of Science (M.S.), Anatomy and Physiology
Boston University 1985 — 1989
B.S., Cardiopulmonary Sciences
Halloran Consulting Group, Inc. September 2014 - Present
Halloran Consulting Group, Inc. January 2014 - Present
Covidien March 2013 - November 2013
Covidien January 2010 - March 2013
Dartmouth College September 2007 - January 2010
University of North Dakota January 2006 - August 2007
Centre, Inc. 2004 - 2005
Skills
Biotechnology, Clinical Trials, Oncology, Clinical Research, Lifesciences, Medical Devices, Research, Data Analysis, Project Management, Publication Planning, Publication Strategy, Publication Development, Clinical Protocols, CTMS, EDC, CRF design, Clinical Study Design, Biologics, Clinical Research..., European Studies, International Studies, International Travel, Medical Writing, Surgical Technology, Clinical Data Management, ICH-GCP, Surgery, Clinical Monitoring, Resea, KOL Identification, Publication, Scientific..., Scientific Writing, GCP, Publications, Life Sciences
Education
Harvard University 2010 — 2014
ALM, Biotechnology
The University of North Dakota 2004 — 2007
BS, Psychology
Embry-Riddle Aeronautical University 2002 — 2004
Aerospace Studies
Halloran Consulting Group, Inc. May 2014 - Present
Halloran Consulting Group, Inc. June 2012 - May 2014
Leerink Swann February 2012 - May 2012
Leerink Swann August 2009 - February 2012
Daiichi Sankyo April 2007 - August 2009
Marketing Drive Worldwide November 2005 - August 2006
Skills
Market Research, Product Management, Pharmaceutical Industry, Managed Care, Project Management, Key Client Relationships, Sales, Business Strategy, Business Development
Education
Hamilton College 2001 — 2005
BA, Psychology
New Hartford High School
Merrimack Pharmaceuticals August 2015 - Present
Halloran Consulting Group, Inc. December 2014 - September 2015
Sathguru Management Consultants March 2013 - December 2014
GenScript Corporation May 2012 - March 2013
Proteostasis Therapeutics, Inc. March 2011 - May 2012
Laboratory for Drug Discovery in Neurodegeneration November 2009 - March 2011
Boston University School of Medicine October 2009 - March 2011
Skills
Drug Development, Drug Discovery, High Throughput..., Biotechnology, Lifesciences, Management Consulting
Education
Loyola University Chicago Stritch School of Medicine 2003 — 2009
Ph.D., Neuroscience
Clark University 1999 — 2003
B.A., Chemistry, Psychology
Halloran Consulting Group, Inc. May 2015 - Present
TLZ Consulting, LLC July 2013 - Present
Halloran Consulting Group, Inc. March 2014 - May 2015
Halloran Consulting Group, Inc. July 2013 - March 2014
Halloran Consulting Group, Inc. April 2012 - July 2013
Cambridge BioMarketing April 2006 - September 2011
IBM 2003 - 2004
Skills
Marketing, Social Media Marketing, Digital Marketing, Microsoft Office, Direct Mail, Photoshop, Marketing Communications, Advertising, Integrated Marketing, Budgets, Digital Strategy, Financial Accounting, Account Reconciliation, Accounting, Accounts Payable, Tax Advisory
Education
Southern New Hampshire University 2013 — 2016
Master of Science (MS), Accounting, 4.0
University of Massachusetts, Amherst 1999 — 2003
BA, International Accounting, Spanish, and a minor in Poly Sci
Halloran Consulting Group, Inc. April 2015 - Present
Plasma Surgical, Inc. September 2012 - April 2015
Bard Medical Division August 2010 - September 2012
Teleflex Medical July 2008 - October 2010
Teleflex Medical October 2004 - July 2008
Weck January 1998 - October 2004
Skills
ISO 13485, FDA, Regulatory Submissions, Quality Systems, Regulatory Strategy, International Regulatory, MDD, AIMDD, CMDCAS, Quality Auditing, Microbiology, Regulations, Medical Devices, ISO, Medical Device Directive, CAPA, Quality Assurance, Quality Management, Strategy, CE marking, V&V, GMP, Quality System, 21 CFR, Validation, Change Control, Regulatory Affairs, Design Control, ISO 14971, PMA, Cross-functional Team...
Education
Campbell University 2007 — 2010
BS, Health Science
Halloran Consulting Group, Inc. September 2015 - Present
Allergan April 2014 - September 2015
Forest Laboratories now Allergan November 2011 - April 2014
Columbia University Medical Center June 2009 - October 2011
Skills
Clinical Trials, FDA, ICH-GCP, 21 CFR Part 11, Strategic Planning, Life Sciences, GCP, CRO, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, CTMS, Clinical Research, Regulatory Submissions, Training, Healthcare, Regulatory Requirements, SOP, IRB, Genetics, Research, Clinical Monitoring, EDC
Education
Montclair State University 2006 — 2010
Bachelor of Science, Biology
The American University of Rome 2008 — 2008
Semester Abroad - Rome, Italy
Halloran Consulting Group, Inc. January 2015 - Present
Bryant University May 2014 - August 2014
Bryant University March 2014 - May 2014
Skills
Microsoft Excel, PowerPoint, Microsoft Word, Salesforce.com, Microsoft Office, Financial Analysis, Access, Social Media, Time Management, Teamwork
Education
Bryant University 2013 — 2014
Master of Business Administration (MBA), General Studies
Bryant University 2009 — 2013
Bachelor of Business Administration (BBA), Finance, General
Holliston High School 2006 — 2009
Innov8tive Research Consulting May 2014 - Present
NYBIO 2014 - Present
Rhythm Pharmaceuticals June 2014 - Present
ImmusanT, Inc. September 2014 - Present
Halloran Consulting Group, Inc. August 2009 - May 2014
W.E.S.T. 2010 - 2011
Novartis Vaccines and Diagnostics 2010 - 2011
Shire HGT 2007 - 2011
ACRP 2000 - 2011
Heathcare Businesses Women's Association 2008 - 2010
Skills
Lifesciences, Clinical Development, Pharmaceutical Industry, Biotechnology, Clinical Trials, Biopharmaceuticals, GCP, Clinical Research, Drug Development, Regulatory Submissions, CRO, Oncology, Regulatory Affairs, FDA, Sop, CTMS, 21 CFR Part 11, EDC, Management, Life Sciences, Process Improvement
Education
Wellesley College 1993 — 1994
Post Bac Pre Med
Connecticut College 1989 — 1993
Sq1 June 2015 - Present
Broad Institute June 2013 - February 2015
Halloran Consulting Group, Inc. December 2012 - June 2013
Haematologic Technologies Inc May 2011 - December 2012
TestAmerica June 2010 - May 2011
Clarkson University January 2010 - May 2010
Skills
Leadership, Project Management, Product Management, Agile Project Management, Internal Audit, Quality System, Manufacturing, Data Analysis
Education
Clarkson University 2006 — 2010
Bachelors of Science, Biology (Minor, Anthropology)
Consultant 2012 - Present
Halloran Consulting Group, Inc. 2014 - 2015
Halloran Consulting Group, Inc. 2014 - 2015
Boston Scientific 2010 - May 2012
Boston Scientific 2004 - 2010
Shire Pharmaceuticals 2003 - 2004
Saint Vincent's Hospital July 2000 - 2003
Skills
Medical Devices, Clinical Trials, FDA, Clinical Research, Cardiology, Interventional..., Oncology, Clinical Development, Biotechnology, Pharmaceutical Industry, Lifesciences, Medicine, Peripheral Vascular, Electrophysiology, Cardiac..., Urology, Women's Health, Neurology, Radiopharmaceuticals, Pulmonology, Adjudication, Quality Assurance, Regulatory Affairs, Safety, Strategic Planning, New Business Development, Operating Budgets, Psychiatry, Team Leadership, Leadership Development, Organizational..., Commercialization, Cross-functional Team..., Vascular, Regulatory Submissions
Education
University of Massachusetts Medical School 1996 — 2000
MD
Boston College
BS, Premed, Psychology
Regis College May 2015 - Present
Halloran Consulting Group, Inc. 2013 - Present
Vertex Pharmaceuticals April 2011 - April 2013
Northeastern University April 2011 - April 2012
Genzyme June 2008 - April 2011
Partners HealthCare January 2007 - June 2008
Skills
Regulatory Affairs, IND, Regulatory Submissions, Lifesciences, Clinical Trials, FDA, Biotechnology, Pharmaceutical Industry, Clinical Research, Oncology, NDA, eCTD, Regulatory Requirements, Clinical Development, GMP, GCP, GLP, 21 CFR Part 11, Clinical Study Design, Drug Development, Life Sciences
Education
Northeastern University 2007 — 2009
MS, Regulatory Affairs
University of Massachusetts Boston 2003 — 2007
BS, Biology
Halloran Consulting Group, Inc. January 2008 - Present
Halloran Consulting Group January 2008 - November 2012
ArQule April 2004 - December 2007
Parexel October 2003 - April 2004
Antigenics January 2001 - October 2003
Genzyme January 1999 - January 2001
DepoTech July 1995 - December 1998
Burroughs Wellcome May 1994 - July 1995
Skills
Biotechnology, Clinical Development, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, Oncology, Lifesciences, FDA, Drug Development, Clinical Research, CRO, Medical Devices, Clinical Operations, Commercialization, GCP, GMP, CTMS, Biopharmaceuticals, Sop, Regulatory Submissions, EDC, Validation, Drug Discovery, Infectious Diseases, 21 CFR Part 11, CAPA, Medical Writing, Quality System, Vaccines, Technology Transfer, R&D, Protocol, Data Management, Pharmacovigilance, ICH-GCP, Clinical Monitoring, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor of Science, Biology
Biogen July 2015 - Present
Biogen Idec May 2007 - Present
Halloran Consulting Group, Inc. October 2013 - December 2013
Biogen Idec October 1998 - May 2007
Biogen December 1999 - February 2005
Skills
IND, Regulatory Submissions, Regulatory Strategy, GCP, Clinical Trials, Regulatory Affairs, Clinical Development, Regulatory Requirements, Neurology, R&D, Cross-functional Team..., Clinical Trial..., Protocol Development, FDA, Vendor Management, Biotechnology, Drug Development, CRO, Project Management, Clinical Study Design, Biologics, ICH-GCP, Clinical Operations, Biopharmaceuticals, Clinical Research, Pharmaceutical Industry
Education
Tufts University 1990 — 1994
BA, Archaeology, Classics
Galmed Pharmaceuticals Ltd. March 2015 - Present
Forest Laboratories November 2010 - Present
Halloran Consulting Group, Inc. October 2010 - Present
Shawna H. Evans, LLC June 2000 - Present
PAREXEL 2011 - 2011
PAREXEL 2011 - 2011
MVG Consulting December 2009 - September 2010
CPEX Pharmaceuticals April 2009 - March 2010
Bright Pharmaceuticals April 2009 - September 2009
MannKind Corporation 2003 - 2009
Skills
Oncology, Clinical Development, Clinical Trials, Medical Writing, Clinical Research, Cardiology, Endocrinology, Hematology, Psychiatry, Medicine, CTMS, GCP, CRO, EDC, Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Submissions, FDA, Regulatory Affairs, Sop, Lifesciences, Clinical Data Management
Education
Castleton University 1994 — 1996
BS, Exercise Physiology
Newbury College 1990 — 1992
Associate of Applied Science, Business Management
Biogen June 2015 - Present
Cubist Pharmaceuticals October 2014 - June 2015
Sanofi January 2014 - October 2014
Halloran Consulting Group, Inc. February 2012 - April 2013
BIND Therapeutics August 2008 - January 2012
Alkermes November 2005 - March 2008
Aerodyne Research June 2004 - October 2005
Skills
GMP, Drug Development, HPLC, Quality System, Analytical Chemistry, Biotechnology, Medical Devices, MS Project, Pharmaceutics, Data Analysis, CAPA, Change Control, Trackwise, Mass Spectrometry, Technology Transfer, Veeva
Education
Boston University Questrom School of Business 2008 — 2011
Master of Business Administration, Health Sector Management and Finance
Boston College 2000 — 2004
Bachelor of Science, Chemistry
Lancaster University 2002 — 2003
Study Abroad Program
Halloran Consulting Group, Inc. August 2015 - Present
Halloran Consulting Group, Inc. February 2014 - August 2015
Boston Scientific August 2010 - September 2013
Boston Scientific April 2009 - August 2010
Boston Scientific Corporation November 2004 - April 2009
Boston Scientific Corporation October 2000 - November 2004
Nova Biomedical May 1999 - October 2000
Skills
Medical Devices, Clinical Trials, CAPA, Healthcare, Start-ups, FDA, Manufacturing, Design Control, Strategic Planning, 21 CFR Part 11, ISO 13485, ISO 14155, Lean Business Processes, ICH guidelines, ICH-GCP, CRO, Clinical Development, Strategy, R, Cross-functional Team...
Education
Babson College - Franklin W. Olin Graduate School of Business 2004 — 2008
MBA, Business
Babson College - Franklin W. Olin Graduate School of Business 2004 — 2008
MS, Management
Worcester Polytechnic Institute 1994 — 1999
BS, Biomedical Engineering
Halloran Consulting Group, Inc. July 2013 - Present
Northeastern University April 2011 - Present
Ziopharm Oncology April 2011 - April 2013
Tolerx, Inc. June 2010 - March 2011
Boston Microfluidics September 2008 - June 2010
Synta Pharmaceuticals March 2007 - September 2008
ImmunoGen, Inc. August 2006 - February 2007
ImmunoGen, Inc. September 2004 - August 2006
Genzyme May 2002 - September 2004
Skills
In Vitro, Regulatory Affairs, Biotechnology, R&D, Oncology, Quality Assurance, Clinical Trials, Lifesciences, Assay Development, Validation, GMP, Immunology, Medical Devices, Sop, Pharmaceutical Industry, FDA, Clinical Development, GCP, Regulatory Submissions, Technology Transfer, Laboratory, Medical Writing, Pharmacovigilance, CTMS, IND, Clinical Research, Drug Discovery, Drug Development, GLP, Regulatory Requirements, Molecular Biology, Biopharmaceuticals, CAPA, CRO, Pharmacology, ELISA, Strategy, Cross-functional Team..., 21 CFR Part 11, Infectious Diseases, HPLC, Biochemistry, Cancer, Vaccines, Protocol, Life Sciences
Education
Northeastern University 2005 — 2007
Master's
Boston University 2000 — 2004
Bachelor
Bancroft School 1996 — 2000
Halloran Consulting Group, Inc. August 2014 - Present
GliaCure, Inc June 2013 - Present
Halloran Consulting Group, Inc. October 2012 - August 2014
Halloran Consulting Group, Inc. 2011 - October 2012
Biogen Idec 2006 - January 2011
Biogen Idec 2005 - 2006
Biogen 2003 - 2005
Biogen 1999 - 2003
Massachusetts General Hospital June 1997 - March 1999
Skills
Program Management, Team Leadership, Clinical Development, Strategic Planning, Cross-functional Team..., Vendor Management, Clinical Trials, R&D, Change Management, Neurology, GCP, Management, Biotechnology, Pharmaceutical Industry, Drug Development, Project Management, Strategy, Clinical Research, Biopharmaceuticals, Business Process..., Lifesciences, CRO, Life Sciences
Education
Saint Michael's College 1993 — 1997
Prosci 2012 — 2012
Change Management Certification
Halloran Consulting Group, Inc. February 2015 - Present
Boston Scientific May 2014 - January 2015
STAAR Surgical November 2013 - May 2014
Bausch + Lomb November 2010 - November 2013
Allergan January 2008 - August 2013
Alcon Laboratories, Inc. March 2008 - November 2010
Khodai Vision Center January 2001 - March 2008
Skills
Ophthalmology, Pharmaceuticals, Regulatory Affairs, FDA, Clinical, Medical Devices, Quality Management, Quality Systems, Medical Research, medical affairs, Clinical Research, Clinical Trials, Medical Education, Medical Writing, Regulatory Requirements, Regulatory Filings, Risk Management, Risk Assessment, Risk Mitigation, Surveillance, Compliance Audits, Marketing Research, Business Strategy, Clinical Development, Biotechnology, Cross-functional Team..., ISO 13485, Regulatory Submissions, CAPA, GMP, ISO 14971, Medicine, Hardware Diagnostics, Design Control, Clinical Operations, Product Launch, Technology Transfer, FDA GMP, Surgery, Commercialization, CTMS, GCP, Quality Assurance, Capital Equipment, Clinical Study Design, Pharmacovigilance, Medical Device R, Protocol, Market Development, 21 CFR Part 11
Education
San Diego State University-California State University 2010 — 2012
Master's degree, Pharmaceutical, Medical Device, and Biologics Regulatory Science
Capital Eye Consultants 1998 — 1999
Residency and Fellowship, Ocular Disease, refractive surgery, cataract surgery, retina
Salus University 1994 — 1998
Doctor of Optometry, Optometry
UCI 1989 — 1994
Bachelor of Arts (B.A.), Psychology
UCI 1989 — 1994
Bachelor's degree, Biology/Biological Sciences, General
Halloran Consulting Group, Inc. May 2015 - Present
Halloran Consulting Group, Inc. November 2014 - May 2015
Quintiles Consulting November 2013 - November 2014
Avarent Consulting LLC March 2013 - November 2014
Baxter Healthcare November 2007 - March 2013
Boston Scientific 2004 - 2007
Control Delivery Systems 2001 - 2004
Skills
Medical Devices, Pharmaceutical Industry, FDA, Clinical Development, Clinical Trials, Validation, Regulatory Affairs, CAPA, Cross-functional Team..., GCP, Biotechnology, Clinical Research, Product Launch, Regulatory Submissions, Pharmacovigilance, Lifesciences, Medical Device Marketing, Voice of the Customer, Key Opinion Leaders, Product Requirements, V&V
Education
Lake Forest Graduate School of Management 2011 — 2013
Master of Business Administration (MBA), Organizational Behavior Studies, Graduated with High Honors
Thomas Jefferson University
Master of Science (M.S.), Medical Microbiology and Bacteriology
Mount Holyoke College
Biology/Biological Sciences, General
Partners HealthCare September 2015 - Present
The Greater Boston Food Bank 2014 - Present
Babson College September 2010 - Present
Halloran Consulting Group, Inc. 2010 - Present
Partners HealthCare 2014 - September 2015
The Greater Boston Food Bank 2004 - 2014
The Greater Boston Food Bank 2009 - 2013
ConforMIS Inc. 2007 - 2010
NxStage Medical, Inc. 2004 - 2007
Boston Scientific 1996 - 2004
Education
The University of Chicago Booth School of Business
Master of Business Administration (M.B.A.), Operations & Finance
Tufts University
Engineer’s Degree, Biomedical/Medical Engineering
GenoSpace July 2015 - September 2015
Halloran Consulting Group, Inc. January 2015 - June 2015
Psious Inc. June 2014 - November 2014
PerkinElmer May 2010 - August 2013
M & R Consultants Corporation March 2009 - May 2010
Sovereign Publications July 2008 - November 2008
Trinity University August 2004 - May 2008
Covidien May 2006 - August 2006
Skills
Marketing, Market Research, Strategy, Brand Development, Competitive Analysis, Business Development, Consumer Marketing, Email Marketing, Online Advertising, Microsoft Office, Account Management, Direct Mail, Cold Calling, Social Networking, Lead Generation, Direct Marketing, Advertising, InDesign, Vendor Management, Vendor Relationships, Third Party Vendor..., Online Lead Generation, Google Adwords, PPC, CRM, SEO, Web Analytics, Facebook, Integrated Marketing, SEM, Online Marketing, Sales, Google Analytics, Marketing Research, Digital Marketing, B2B, Analytics, Brand Management, B2B Marketing, Management, Marketing Strategy, International Marketing, Global Strategy, Pricing Strategy, Thrive in A Fast-paced...
Education
ESADE Business School 2013 — 2014
Master of Business Administration (M.B.A.), International Marketing & Strategy
Trinity University 2004 — 2008
BS, Business Administration-Marketing
Queen Mary University of London 2006 — 2006
NA, Study Abroad Programme
Halloran Consulting Group, Inc. August 2015 - Present
Synageva BioPharma Corp. January 2015 - August 2015
Synageva BioPharma Corp. November 2013 - January 2015
ARIAD Pharmaceuticals, Inc. May 2013 - November 2013
Ziopharm Oncology March 2012 - May 2013
Ziopharm Oncology June 2011 - March 2012
Tolerx, Inc. May 2008 - March 2011
Skills
Clinical Trials, Biotechnology, Clinical Development, Oncology, Pharmaceutical Industry, GCP, Lifesciences, Drug Development, FDA, Immunology, CTMS, Clinical Research, Regulatory Affairs, Sop, CRO, EDC, Clinical Data Management, Clinical Monitoring, IND, Clinical Operations, Therapeutic Areas, Biopharmaceuticals, ICH-GCP, Life Sciences, SOP
Education
Northeastern University 2010 — 2016
Masters in Project Management, Focus on Clinical Trial Design
University of Southern Maine 2004 — 2008
BA, Anthropology, Geography, Pre-Med
Trius Therapeutics November 2011 - Present
Brenda Tellone Consulting, LLC March 2010 - Present
Veritas Clinical Consultants, Inc. February 2011 - February 2012
Premier Research Group LTD June 2010 - February 2011
Halloran Consulting Group, Inc. 2009 - June 2010
Schering-Plough Research Institute January 2006 - March 2009
Schering-Plough Research Institute January 2002 - March 2006
Schering-Plough Research Institute January 2000 - January 2002
PAREXEL March 1996 - December 1999
PAREXEL September 1995 - March 1996
Skills
Clinical Trials, CRO, Oncology, Pharmaceutical Industry, Infectious Diseases, Sop, FDA, Clinical Research, Immunology, IND, Protocol, CTMS, Clinical Development, GCP, Clinical Monitoring, ICH-GCP, Regulatory Submissions, Therapeutic Areas, Biotechnology, Regulatory Affairs, Drug Development, Quality Assurance, GMP, Lifesciences, EDC, Clinical Data Management, Validation, SOP
Education
Rutgers University-New Brunswick 1974 — 1976
BS, Animal Science
Halloran Consulting Group, Inc. July 2014 - Present
Shire Pharmaceuticals June 2011 - June 2014
Shire Pharmaceuticals January 2009 - June 2011
Skills
Trackwise, Biopharmaceuticals, GMP, CAPA, 21 CFR Part 11, Sop, FDA, Biotechnology, Regulatory Submissions, IND, GxP, GLP, Filtration, Pharmaceutical Industry, LIMS, Change Control, Technology Transfer, Aseptic Processing
Education
Binghamton University 2004 — 2008
BA, Biology, Anthropology, Evolution, Philosophy, Women's Studies
The Hebrew University 2003 — 2004
Nativ College Leadership Program
Partners HealthCare- Innovation February 2015 - Present
Digizyme, Inc. March 2012 - Present
Halloran Consulting Group, Inc. October 2011 - October 2012
Boston Scientific August 1991 - June 2011
Skills
Medical Devices, Program Management, Clinical Research, Product Development, FDA, R&D, Management, Strategy, Cross-functional Team..., Commercialization, Strategic Partnerships, Strategic Planning, Mergers & Acquisitions, Lifesciences, Biotechnology, Clinical Development
Education
Harvard School of Public Health 1996 — 1999
MS, Physiology
Brown University 1983 — 1986
MS, Engineering
The George Washington University 1980 — 1982
BS, Mechanical Engineering
Halloran Consulting Group, Inc. April 2015 - Present
Baylis Medical Company November 2013 - Present
Spice4life March 2013 - June 2013
Conventures, Inc. May 2012 - September 2012
UNH Campus Recreation September 2009 - May 2012
NBC Sports & Olympics June 2011 - August 2011
Skills
Sports, Marketing, Time Management, Sponsorship, Research, Sales, Recruiting, Sports Marketing, Project Planning, Event Planning, Social Media, Public Relations, Market Research, Event Management, Marketing Strategy
Education
University of New Hampshire 2008 — 2012
BS, Recreation Management & Policy
Sun Life Financial August 2015 - Present
The Research Group of Christine Thomas January 2013 - May 2015
Brandeis University Hiatt Career Center September 2011 - May 2015
Brandeis University Business Department January 2015 - April 2015
Halloran Consulting Group, Inc. June 2014 - December 2014
University of Southern California June 2013 - August 2013
Aflac May 2012 - July 2012
Education
Brandeis University 2011 — 2015
Bachelor of Science
Mira Costa High School 2007 — 2011