Ocera Therapeutics
Industry: Company
DescriptionFounded: 2004 Parent organization: MAK LLC
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Ocera Therapeutics Employees
Employee
Years
Job
Industry
Michael Byrnes Michael Byrnes's Ocera Therapeutics Experience December 2014 - Present
Job Chief Financial Officer at Ocera Therapeutics
Industry Biotechnology
Experience
Ocera Therapeutics December 2014 - Present
Ocera Therapeutics June 2014 - December 2014
Maxygen March 2010 - December 2014
NeurogesX, Inc. June 2007 - March 2010
Lipid Sciences 2002 - 2007
ADAC Laboratories, A Philips Medical Systems Company 2000 - 2002
Bay View Capital 1997 - 2000
Skills
Strategic Planning, Financial Planning, Financial Modeling, SEC Reporting, Technical Accounting, Revenue Recognition, Financial Reporting, Accounting, Sarbanes-Oxley, Biotechnology, Due Diligence, Financial Analysis, Treasury, SEC filings, Sarbanes-Oxley Act, Forecasting, Account Reconciliation, General Ledger, Finance, Mergers & Acquisitions, Strategic Financial..., Strategy, Internal Controls, IPO, Lifesciences, SEC Filings, Life Sciences
Education
Santa Clara University 1998 — 2000
BSC, Finance
California State University-East Bay 2003 — 2005
MBA, Finance
Ocera Therapeutics December 2014 - Present
Ocera Therapeutics June 2014 - December 2014
Maxygen March 2010 - December 2014
NeurogesX, Inc. June 2007 - March 2010
Lipid Sciences 2002 - 2007
ADAC Laboratories, A Philips Medical Systems Company 2000 - 2002
Bay View Capital 1997 - 2000
Skills
Strategic Planning, Financial Planning, Financial Modeling, SEC Reporting, Technical Accounting, Revenue Recognition, Financial Reporting, Accounting, Sarbanes-Oxley, Biotechnology, Due Diligence, Financial Analysis, Treasury, SEC filings, Sarbanes-Oxley Act, Forecasting, Account Reconciliation, General Ledger, Finance, Mergers & Acquisitions, Strategic Financial..., Strategy, Internal Controls, IPO, Lifesciences, SEC Filings, Life Sciences
Education
Santa Clara University 1998 — 2000
BSC, Finance
California State University-East Bay 2003 — 2005
MBA, Finance
Anne McKay Anne McKay's Ocera Therapeutics Experience January 2014 - Present
Job President at Anne McKay Inc.
Industry Biotechnology
Experience
Anne McKay Inc. June 2010 - Present
Ocera Therapeutics January 2014 - Present
Biolex February 2008 - May 2010
BWA Consulting September 2003 - January 2008
Triangle Pharmaceuticals October 1996 - May 2003
Burroughs Wellcome January 1980 - June 1995
Education
MSU 1972 — 1976
BS, Animal Science
Anne McKay Inc. June 2010 - Present
Ocera Therapeutics January 2014 - Present
Biolex February 2008 - May 2010
BWA Consulting September 2003 - January 2008
Triangle Pharmaceuticals October 1996 - May 2003
Burroughs Wellcome January 1980 - June 1995
Education
MSU 1972 — 1976
BS, Animal Science
Elsa Nyborg Mondou, MD Elsa Nyborg Mondou, MD's Ocera Therapeutics Experience July 2013 - June 2014
Job Medical Director, Clinical Development at Grifols Therapeutics
Industry Pharmaceuticals
Experience
Grifols Therapeutics Inc. July 2014 - Present
Ocera Therapeutics July 2013 - June 2014
Tranzyme Pharma March 2012 - July 2013
PRA International December 2010 - March 2012
Gilead Sciences January 2008 - December 2010
Triangle/Gilead 2001 - 2010
Cato Research Ltd. 1995 - 2000
Skills
IND, Drug Development, Clinical Development, Clinical Trials, CRO, Therapeutic Areas, Protocol, Clinical Monitoring, Clinical Research, Infectious Diseases, NDA, Pharmaceutical Industry, Pharmacology, CTMS, Regulatory Submissions, Medicine, GCP, EDC, ICH-GCP, Medical Writing, Oncology, Neurology, Regulatory Affairs, Clinical Pharmacology, Medical Affairs
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1978 — 1982
M.D., Medicine
Grifols Therapeutics Inc. July 2014 - Present
Ocera Therapeutics July 2013 - June 2014
Tranzyme Pharma March 2012 - July 2013
PRA International December 2010 - March 2012
Gilead Sciences January 2008 - December 2010
Triangle/Gilead 2001 - 2010
Cato Research Ltd. 1995 - 2000
Skills
IND, Drug Development, Clinical Development, Clinical Trials, CRO, Therapeutic Areas, Protocol, Clinical Monitoring, Clinical Research, Infectious Diseases, NDA, Pharmaceutical Industry, Pharmacology, CTMS, Regulatory Submissions, Medicine, GCP, EDC, ICH-GCP, Medical Writing, Oncology, Neurology, Regulatory Affairs, Clinical Pharmacology, Medical Affairs
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1978 — 1982
M.D., Medicine
Nancy Helton Nancy Helton's Ocera Therapeutics Experience July 2013 - Present
Job Sr Director Project Managment at Ocera Therapeutics
Industry Biotechnology
Experience
Ocera Therapeutics July 2013 - Present
Tranzyme Pharma December 2011 - July 2013
Pharmasset, Inc. September 2011 - November 2011
Quintiles March 2011 - August 2011
Gilead Sciences April 1997 - December 2010
PPD July 1994 - April 1997
Burroughs Wellcome Co. 1977 - 1994
Skills
Regulatory Submissions, Clinical Development, Drug Development, Biotechnology, Pharmaceutical Industry, CRO, Clinical Research, Project Management, Regulatory Affairs, EDC, Strategy, Oncology, Clinical Trials, Clinical Monitoring, IND, CTMS
Education
University of Missouri-Columbia 1971 — 1975
BA, Honors Interdisciplinary Major
Ocera Therapeutics July 2013 - Present
Tranzyme Pharma December 2011 - July 2013
Pharmasset, Inc. September 2011 - November 2011
Quintiles March 2011 - August 2011
Gilead Sciences April 1997 - December 2010
PPD July 1994 - April 1997
Burroughs Wellcome Co. 1977 - 1994
Skills
Regulatory Submissions, Clinical Development, Drug Development, Biotechnology, Pharmaceutical Industry, CRO, Clinical Research, Project Management, Regulatory Affairs, EDC, Strategy, Oncology, Clinical Trials, Clinical Monitoring, IND, CTMS
Education
University of Missouri-Columbia 1971 — 1975
BA, Honors Interdisciplinary Major
Mahnaz Ebrahimi, CPA, CEP, CCM Mahnaz Ebrahimi, CPA, CEP, CCM's Ocera Therapeutics Experience 2013 - 2013
Job Chief Financial Officer
Industry Biotechnology
Experience
Flux Power April 2015 - Present
ME Financial/SEC Consulting 2006 - Present
Polaris Pharmaceuticals 2014 - 2014
Ocera Therapeutics 2013 - 2013
Affymetrix 2012 - 2012
eBioscience 2010 - 2012
Illumina 2007 - 2010
SGX Pharmaceuticals November 2006 - September 2007
IT&E International January 2006 - August 2006
Favrille 2005 - 2005
Skills
Sarbanes-Oxley Act, Financial Analysis, Mergers & Acquisitions, Finance, Accounting, Management, Internal Controls, Analysis, Project Planning, Cost Accounting, Forecasting, Mergers, Auditing, Consolidation, Strategy, Cash Management, Internal Audit, Strategic Planning, Stock Option Accounting, NIH Grant Management, XBRL tagging/Review
Education
National University 1979 — 1980
Masters, Business Administration
Flux Power April 2015 - Present
ME Financial/SEC Consulting 2006 - Present
Polaris Pharmaceuticals 2014 - 2014
Ocera Therapeutics 2013 - 2013
Affymetrix 2012 - 2012
eBioscience 2010 - 2012
Illumina 2007 - 2010
SGX Pharmaceuticals November 2006 - September 2007
IT&E International January 2006 - August 2006
Favrille 2005 - 2005
Skills
Sarbanes-Oxley Act, Financial Analysis, Mergers & Acquisitions, Finance, Accounting, Management, Internal Controls, Analysis, Project Planning, Cost Accounting, Forecasting, Mergers, Auditing, Consolidation, Strategy, Cash Management, Internal Audit, Strategic Planning, Stock Option Accounting, NIH Grant Management, XBRL tagging/Review
Education
National University 1979 — 1980
Masters, Business Administration
Renu Jain's Ocera Therapeutics Experience September 2015 - Present
Job VP, Clinical Development, Ocera Therapeutics
Industry Pharmaceuticals
Experience
Ocera Therapeutics September 2015 - Present
Grifols June 2011 - Present
Renu Jain Consulting March 2011 - May 2011
Argos Therapeutics March 2008 - March 2011
GlaxoSmithKline September 1999 - March 2008
Glaxo SmithKline 1999 - 2008
ECU 1993 - 1997
Skills
Clinical Trials, Clinical Development, CRO, Oncology, Infectious Diseases, Drug Development, Clinical Research, Regulatory Submissions, Therapeutic Areas, FDA, Sop, Diabetes, IND, Protocol, Molecular Biology, Clinical Pharmacology, Pharmacokinetics, Clinical Operations, GCP, CTMS, Pharmaceutical Industry, Clinical Monitoring, Medical Writing, EDC, Pharmacology, Immunology, Drug Discovery, Pharmacovigilance, Medical Devices, Regulatory Affairs, Protein Chemistry, ICH-GCP, Biotechnology, Biologics, Biopharmaceuticals, GLP, Lifesciences, Medical Affairs, Vaccines, Life Sciences, SOP
Education
Regulatory Affairs Professional Society 2011 — 2011
RAC, Regulatory Affairs
East Carolina University 1994 — 1997
Ph.D, Biochemistry
Methodist High School
High School
Ocera Therapeutics September 2015 - Present
Grifols June 2011 - Present
Renu Jain Consulting March 2011 - May 2011
Argos Therapeutics March 2008 - March 2011
GlaxoSmithKline September 1999 - March 2008
Glaxo SmithKline 1999 - 2008
ECU 1993 - 1997
Skills
Clinical Trials, Clinical Development, CRO, Oncology, Infectious Diseases, Drug Development, Clinical Research, Regulatory Submissions, Therapeutic Areas, FDA, Sop, Diabetes, IND, Protocol, Molecular Biology, Clinical Pharmacology, Pharmacokinetics, Clinical Operations, GCP, CTMS, Pharmaceutical Industry, Clinical Monitoring, Medical Writing, EDC, Pharmacology, Immunology, Drug Discovery, Pharmacovigilance, Medical Devices, Regulatory Affairs, Protein Chemistry, ICH-GCP, Biotechnology, Biologics, Biopharmaceuticals, GLP, Lifesciences, Medical Affairs, Vaccines, Life Sciences, SOP
Education
Regulatory Affairs Professional Society 2011 — 2011
RAC, Regulatory Affairs
East Carolina University 1994 — 1997
Ph.D, Biochemistry
Methodist High School
High School
Linda Grais's Ocera Therapeutics Experience 2012 - Present
Job
Industry Biotechnology
Experience
Ocera Therapeutics 2012 - Present
InterWest Partners 2005 - 2011
SGX Pharmaceuticals 1997 - 2004
Wilson Sonsini Goodrich & Rosati 1993 - 1997
Institute of Medicine, National Academies of Sciences 1988 - 1991
University of California, San Francisco 1984 - 1990
Skills
Start-ups, Venture Capital, Biotechnology, Life Sciences, Mergers & Acquisitions, Due Diligence, Strategic Planning, Entrepreneurship, Pharmaceutical Industry, Strategy, Drug Discovery, Business Development, Oncology
Education
Stanford University Law School 1990 — 1993
Juris Doctor (J.D.)
Yale University School of Medicine 1980 — 1984
Doctor of Medicine (M.D.)
Yale University 1974 — 1979
Bachelor's Degree, Philosophy, Highest Departmental Honors, Magna Cum Laude and Phi Beta Kappa
Ocera Therapeutics 2012 - Present
InterWest Partners 2005 - 2011
SGX Pharmaceuticals 1997 - 2004
Wilson Sonsini Goodrich & Rosati 1993 - 1997
Institute of Medicine, National Academies of Sciences 1988 - 1991
University of California, San Francisco 1984 - 1990
Skills
Start-ups, Venture Capital, Biotechnology, Life Sciences, Mergers & Acquisitions, Due Diligence, Strategic Planning, Entrepreneurship, Pharmaceutical Industry, Strategy, Drug Discovery, Business Development, Oncology
Education
Stanford University Law School 1990 — 1993
Juris Doctor (J.D.)
Yale University School of Medicine 1980 — 1984
Doctor of Medicine (M.D.)
Yale University 1974 — 1979
Bachelor's Degree, Philosophy, Highest Departmental Honors, Magna Cum Laude and Phi Beta Kappa
Ken Ruettimann Ken Ruettimann's Ocera Therapeutics Experience November 2013 - January 2015
Job VP, Manufacturing at Aerie Pharmaceuticals
Industry Pharmaceuticals
Experience
Aerie Pharmaceuticals January 2015 - Present
Ocera Therapeutics November 2013 - January 2015
Self Employed January 2013 - November 2013
Tranzyme Pharma May 2011 - December 2012
Inspire Pharmaceuticals July 2008 - February 2011
Pfizer May 2003 - March 2007
Pharmacia January 2000 - April 2003
Searle June 1999 - December 2000
Monsanto May 1997 - May 1999
Monsanto, Office of Science and Technology June 1996 - May 1997
Skills
Six Sigma certification, GMP, Pharmaceutical Industry, Six Sigma, Drug Development, Strategy, Manufacturing, Leadership, Process Simulation, Project Management, Business Process..., Product Development, Management, Supply Chain Management, Supply Chain, Strategic Planning, CAPA, Quality System, 21 CFR Part 11, Analytical Chemistry, Continuous Improvement, FDA, Clinical Research, Validation, Technology Transfer, CRO, Chemical Engineering, Sop, Software Documentation, R&D, Regulatory Submissions, Lifesciences, Organizational..., Organic Chemistry, Chemistry, Process Improvement
Education
Purdue University 1987 — 1991
PhD, Chemical Engineering
Purdue University 1984 — 1987
MS, Chemical Engineering
Virginia Polytechnic Institute and State University 1981 — 1984
BS, Chemical Engineering
Aerie Pharmaceuticals January 2015 - Present
Ocera Therapeutics November 2013 - January 2015
Self Employed January 2013 - November 2013
Tranzyme Pharma May 2011 - December 2012
Inspire Pharmaceuticals July 2008 - February 2011
Pfizer May 2003 - March 2007
Pharmacia January 2000 - April 2003
Searle June 1999 - December 2000
Monsanto May 1997 - May 1999
Monsanto, Office of Science and Technology June 1996 - May 1997
Skills
Six Sigma certification, GMP, Pharmaceutical Industry, Six Sigma, Drug Development, Strategy, Manufacturing, Leadership, Process Simulation, Project Management, Business Process..., Product Development, Management, Supply Chain Management, Supply Chain, Strategic Planning, CAPA, Quality System, 21 CFR Part 11, Analytical Chemistry, Continuous Improvement, FDA, Clinical Research, Validation, Technology Transfer, CRO, Chemical Engineering, Sop, Software Documentation, R&D, Regulatory Submissions, Lifesciences, Organizational..., Organic Chemistry, Chemistry, Process Improvement
Education
Purdue University 1987 — 1991
PhD, Chemical Engineering
Purdue University 1984 — 1987
MS, Chemical Engineering
Virginia Polytechnic Institute and State University 1981 — 1984
BS, Chemical Engineering
Anne VanLent Anne VanLent's Ocera Therapeutics Experience March 2011 - Present
Job Financial consultant for emerging growth life sciences companies, public company director
Industry Pharmaceuticals
Experience
Onconova Therapeutics July 2013 - Present
Biota Pharmaceuticals May 2013 - Present
Aegerion Pharmaceuticals March 2013 - Present
AMV Advisors May 2008 - Present
Ocera Therapeutics March 2011 - Present
Integra LifeSciences December 2004 - May 2013
Penwest Pharmaceuticals July 1997 - November 2010
Barrier Therapeutics May 2002 - May 2008
Sarnoff Corporation August 1997 - October 2001
The Liposome Company, Inc. March 1985 - February 1993
Skills
Venture Capital, IPO, Licensing, Intellectual Property, Managerial Finance, Lifesciences, Pharmaceutical Industry, Biotechnology, Due Diligence, Patents, Mergers, Medical Devices, Strategic Planning, Business Planning, Start-ups
Education
University de Strasbourg, France 1970 — 1971
graduate courses, Biophysics
Mount Holyoke College 1966 — 1970
Bachelor of Arts (B.A.), Physics
Onconova Therapeutics July 2013 - Present
Biota Pharmaceuticals May 2013 - Present
Aegerion Pharmaceuticals March 2013 - Present
AMV Advisors May 2008 - Present
Ocera Therapeutics March 2011 - Present
Integra LifeSciences December 2004 - May 2013
Penwest Pharmaceuticals July 1997 - November 2010
Barrier Therapeutics May 2002 - May 2008
Sarnoff Corporation August 1997 - October 2001
The Liposome Company, Inc. March 1985 - February 1993
Skills
Venture Capital, IPO, Licensing, Intellectual Property, Managerial Finance, Lifesciences, Pharmaceutical Industry, Biotechnology, Due Diligence, Patents, Mergers, Medical Devices, Strategic Planning, Business Planning, Start-ups
Education
University de Strasbourg, France 1970 — 1971
graduate courses, Biophysics
Mount Holyoke College 1966 — 1970
Bachelor of Arts (B.A.), Physics
M Scott Harris's Ocera Therapeutics Experience 2007 - 2009
Job CoFounder and Chief Medical Officer at Lyric Pharmaceuticals and Principal, Middleburg Consultants
Industry Biotechnology
Experience
Lyric Pharmaceuticals February 2015 - Present
Middleburg Consultants, Inc., and GastroCentrics (subsidiary) 2005 - Present
Georgetown University School of Medicine (Gastroenterology) 2005 - Present
Avaxia Biologics 2012 - 2015
Ocera Therapeutics 2007 - 2009
Napo Pharmaceuticals 2006 - 2008
Skills
Clinical Trials, Clinical Development, Pharmaceuticals, Biotechnology, Gastroenterology, Translational Medicine, Regulatory Strategy, Clinical Research, Clinical Trial..., Regulatory Affairs, R&D, CTMS, Pharmaceutical Industry, Drug Development, FDA, Therapeutic Areas, Immunology, Protocol, Strategy, Pharmaceutics, Medicine, Infectious Diseases, Medical Writing, Lifesciences, Medical Affairs, Oncology, CRO, Drug Discovery, Pharmacology, Regulatory Submissions, Biopharmaceuticals, Biologics
Education
Harvard Medical School
MD, Medicine
Harvard University
BA, Chemistry
University of Wisconsin Medical School
M.S., Administrative Medicine and Population Health
Lyric Pharmaceuticals February 2015 - Present
Middleburg Consultants, Inc., and GastroCentrics (subsidiary) 2005 - Present
Georgetown University School of Medicine (Gastroenterology) 2005 - Present
Avaxia Biologics 2012 - 2015
Ocera Therapeutics 2007 - 2009
Napo Pharmaceuticals 2006 - 2008
Skills
Clinical Trials, Clinical Development, Pharmaceuticals, Biotechnology, Gastroenterology, Translational Medicine, Regulatory Strategy, Clinical Research, Clinical Trial..., Regulatory Affairs, R&D, CTMS, Pharmaceutical Industry, Drug Development, FDA, Therapeutic Areas, Immunology, Protocol, Strategy, Pharmaceutics, Medicine, Infectious Diseases, Medical Writing, Lifesciences, Medical Affairs, Oncology, CRO, Drug Discovery, Pharmacology, Regulatory Submissions, Biopharmaceuticals, Biologics
Education
Harvard Medical School
MD, Medicine
Harvard University
BA, Chemistry
University of Wisconsin Medical School
M.S., Administrative Medicine and Population Health
Megan Mannix (Haugen)'s Ocera Therapeutics Experience June 2014 - Present
Job Executive Assistant to the President & CEO at Ocera Therapeutics
Industry Pharmaceuticals
Experience
Ocera Therapeutics June 2014 - Present
Skyline Ventures February 2010 - June 2014
Openwave September 2005 - May 2006
Openwave January 2003 - September 2005
Openwave August 2000 - December 2002
Openwave April 1999 - August 2000
Openwave March 1997 - April 1999
Skills
Administrative..., Management, Calendars, Salesforce.com, Calendaring, Sales, PowerPoint, Training, Project Management, Event Planning, Program Management, Start-ups, Visio, Access, Time Management, Venture Capital, MS Project, QuickBooks, Office Management, Microsoft Excel, Intranet Portals, Organizational Charts, Sales Operations, Business Operations, Internal Audit, Process Scheduler, Travel Arrangements, Cross-functional Team..., Product Marketing, SharePoint, HTML, Microsoft Word, Office Administration, Employee Training, Security Operations, Security Management, Oracle Applications, Facilities Operations, International Relations, Questionnaire Design, Concur, Egencia
Education
Notre Dame de Namur University
BA, Liberal Studies
Colorado State University 1991 — 1995
Early Childhood Education
Notre Dame High School Belmont 1987 — 1991
Ocera Therapeutics June 2014 - Present
Skyline Ventures February 2010 - June 2014
Openwave September 2005 - May 2006
Openwave January 2003 - September 2005
Openwave August 2000 - December 2002
Openwave April 1999 - August 2000
Openwave March 1997 - April 1999
Skills
Administrative..., Management, Calendars, Salesforce.com, Calendaring, Sales, PowerPoint, Training, Project Management, Event Planning, Program Management, Start-ups, Visio, Access, Time Management, Venture Capital, MS Project, QuickBooks, Office Management, Microsoft Excel, Intranet Portals, Organizational Charts, Sales Operations, Business Operations, Internal Audit, Process Scheduler, Travel Arrangements, Cross-functional Team..., Product Marketing, SharePoint, HTML, Microsoft Word, Office Administration, Employee Training, Security Operations, Security Management, Oracle Applications, Facilities Operations, International Relations, Questionnaire Design, Concur, Egencia
Education
Notre Dame de Namur University
BA, Liberal Studies
Colorado State University 1991 — 1995
Early Childhood Education
Notre Dame High School Belmont 1987 — 1991
Caroline Laplaca's Ocera Therapeutics Experience September 2005 - July 2010
Job Executive Director Clinical Operations at Arrowhead Research Corporation
Industry Biotechnology
Experience
Arrowhead Research Corporation July 2014 - Present
InClin, Inc 2013 - 2014
Shiloh GCP Systems, Inc. June 2011 - July 2013
Ocera Therapeutics September 2005 - July 2010
Vical Incorporated 2003 - 2005
Elan Pharmaceuticals 2002 - 2002
Baxter BioScience 1996 - 2002
Skills
Clinical Development, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Biopharmaceuticals, Clinical Operations, FDA, Drug Development, CTMS, Sop, Oncology, Clinical Research, Biotechnology, Regulatory Submissions, Lifesciences, Medical Devices, Therapeutic Areas, Quality Assurance, EDC, 21 CFR Part 11, Clinical Study Design, Medical Affairs, Neurology, Regulatory Affairs, Pharmaceutics, Vaccines, Infectious Diseases, IND, Clinical Monitoring, Medical Writing, Pharmacovigilance, Protocol, Clinical Data Management, Immunology, ICH-GCP, GLP, Computer System..., Gastroenterology, Dermatology, Drug Discovery, Validation, Endocrinology, Hematology, Regulatory Requirements, Pharmacology, Commercialization, SOP, Life Sciences
Education
Georgetown University 1972 — 1978
Arrowhead Research Corporation July 2014 - Present
InClin, Inc 2013 - 2014
Shiloh GCP Systems, Inc. June 2011 - July 2013
Ocera Therapeutics September 2005 - July 2010
Vical Incorporated 2003 - 2005
Elan Pharmaceuticals 2002 - 2002
Baxter BioScience 1996 - 2002
Skills
Clinical Development, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Biopharmaceuticals, Clinical Operations, FDA, Drug Development, CTMS, Sop, Oncology, Clinical Research, Biotechnology, Regulatory Submissions, Lifesciences, Medical Devices, Therapeutic Areas, Quality Assurance, EDC, 21 CFR Part 11, Clinical Study Design, Medical Affairs, Neurology, Regulatory Affairs, Pharmaceutics, Vaccines, Infectious Diseases, IND, Clinical Monitoring, Medical Writing, Pharmacovigilance, Protocol, Clinical Data Management, Immunology, ICH-GCP, GLP, Computer System..., Gastroenterology, Dermatology, Drug Discovery, Validation, Endocrinology, Hematology, Regulatory Requirements, Pharmacology, Commercialization, SOP, Life Sciences
Education
Georgetown University 1972 — 1978
Michelle Resler's Ocera Therapeutics Experience October 2007 - May 2011
Job Senior Director, Clinical Operations at Auspex Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Auspex Pharmaceuticals, Inc. June 2014 - Present
Sophiris Bio, Corp. May 2011 - June 2014
Ocera Therapeutics October 2007 - May 2011
Avera Pharmaceuticals January 2006 - September 2007
Elan Pharmaceuticals January 2002 - January 2006
Quintiles 1995 - 2000
Education
University of California, San Diego
B.S., Biochemistry and Cell Biology
Auspex Pharmaceuticals, Inc. June 2014 - Present
Sophiris Bio, Corp. May 2011 - June 2014
Ocera Therapeutics October 2007 - May 2011
Avera Pharmaceuticals January 2006 - September 2007
Elan Pharmaceuticals January 2002 - January 2006
Quintiles 1995 - 2000
Education
University of California, San Diego
B.S., Biochemistry and Cell Biology
Mitchell Cohen, PharmD's Ocera Therapeutics Experience 2007 - 2009
Job Associate Director Medical Sciences at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences July 2013 - Present
AMAG Pharmaceuticals 2012 - Present
Auxilium Pharmaceuticals May 2009 - February 2012
Ocera Therapeutics 2007 - 2009
Amgen 2002 - 2005
AstraZeneca 2000 - 2002
Skills
KOL Development, Project Execution, Strategic Communications, Clinical Trials, Medical Education, Clinical Research, Therapeutic areas, Pharmaceuticals, Clinical Development, Gastroenterology, Neurology, Orthopedics, Urology, GCP, medical liaison, Cardiology, Oncology, Relationship Development, medical affairs, Pharmaceutical Industry, Medical Affairs, Biotechnology, Therapeutic Areas, Managed Care, Orthopedic, Lifesciences, Rheumatology, Medical Writing, Medicine, KOL development, Hematology, Pharmacology
Education
University of Arkansas for Medical Sciences 1997 — 1999
PharmD, Clinical Pharmacy
University of Rhode Island
BS, Pharmacy
Gilead Sciences July 2013 - Present
AMAG Pharmaceuticals 2012 - Present
Auxilium Pharmaceuticals May 2009 - February 2012
Ocera Therapeutics 2007 - 2009
Amgen 2002 - 2005
AstraZeneca 2000 - 2002
Skills
KOL Development, Project Execution, Strategic Communications, Clinical Trials, Medical Education, Clinical Research, Therapeutic areas, Pharmaceuticals, Clinical Development, Gastroenterology, Neurology, Orthopedics, Urology, GCP, medical liaison, Cardiology, Oncology, Relationship Development, medical affairs, Pharmaceutical Industry, Medical Affairs, Biotechnology, Therapeutic Areas, Managed Care, Orthopedic, Lifesciences, Rheumatology, Medical Writing, Medicine, KOL development, Hematology, Pharmacology
Education
University of Arkansas for Medical Sciences 1997 — 1999
PharmD, Clinical Pharmacy
University of Rhode Island
BS, Pharmacy
Cynthia Wright, CPA, MBA's Ocera Therapeutics Experience February 2008 - July 2010
Job Abbott Laboratories
Industry Accounting
Experience
Abbott 2013 - Present
Science & Technology International, Inc. March 2011 - April 2013
Ocera Therapeutics February 2008 - July 2010
The Immune Response Corporation 2006 - 2008
PRN Wright Physical Therapy September 1998 - July 2006
Community Water Company 1989 - 1998
Skills
Biotechnology, SEC filings, International Accounting, Revenue Recognition, Consolidated Financial..., Corporate FP&A, Financial Accounting, Monthly Closing, Year-end Close, Audit Management, Fixed Asset Management, Financial Forecasting, Financial Analysis, Financial Crisis..., Corporate Finance, Financial Reporting, Government Contracting, Human Resources, Cash Flow Forecasting, Strategic Communications, Pharmaceutical Industry, Lifesciences, Medical Devices, Physical Therapy, Utility Industry, Healthcare, Account Management, Controllers, Sales & Use Tax, QuickBooks, Mas 90, Deltek, OMB Circular A-133, DCAA, Sarbanes-Oxley, Foreign Currency..., Financial Modeling, Payroll
Education
California State University-San Marcos - College of Business Administration 2005 — 2007
MBA, Masters Business Administration
Univerisity of Utah 1978 — 1980
Bachelor of Science, Finance
Brigham Young University 1975 — 1978
Business Administration and Management, General
University High School 1972 — 1975
Abbott 2013 - Present
Science & Technology International, Inc. March 2011 - April 2013
Ocera Therapeutics February 2008 - July 2010
The Immune Response Corporation 2006 - 2008
PRN Wright Physical Therapy September 1998 - July 2006
Community Water Company 1989 - 1998
Skills
Biotechnology, SEC filings, International Accounting, Revenue Recognition, Consolidated Financial..., Corporate FP&A, Financial Accounting, Monthly Closing, Year-end Close, Audit Management, Fixed Asset Management, Financial Forecasting, Financial Analysis, Financial Crisis..., Corporate Finance, Financial Reporting, Government Contracting, Human Resources, Cash Flow Forecasting, Strategic Communications, Pharmaceutical Industry, Lifesciences, Medical Devices, Physical Therapy, Utility Industry, Healthcare, Account Management, Controllers, Sales & Use Tax, QuickBooks, Mas 90, Deltek, OMB Circular A-133, DCAA, Sarbanes-Oxley, Foreign Currency..., Financial Modeling, Payroll
Education
California State University-San Marcos - College of Business Administration 2005 — 2007
MBA, Masters Business Administration
Univerisity of Utah 1978 — 1980
Bachelor of Science, Finance
Brigham Young University 1975 — 1978
Business Administration and Management, General
University High School 1972 — 1975
Anette Wade's Ocera Therapeutics Experience August 2015 - Present
Job Senior Clinical Project Manager at Ocera Therapeutics
Industry Pharmaceuticals
Experience
Ocera Therapeutics August 2015 - Present
UCB September 2012 - August 2015
UCB October 2007 - August 2012
UCB October 2006 - September 2007
UCB March 2005 - October 2006
Biostratum, Inc. October 2001 - March 2005
Medco / King Pharmaceuticals R&D, Inc. August 1999 - October 2001
Jacobs Sverdrup 1989 - 1999
Skills
Biotechnology, Pharmaceutical Industry, Clinical Trials, Clinical Research, Clinical Development, Drug Development, FDA, GCP, ICH-GCP, Protocol, EDC, Regulatory Submissions, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, Clinical Monitoring, Therapeutic Areas, Infectious Diseases, Oncology, CRO, Medical Writing, CTMS, 21 CFR Part 11, Immunology, Biopharmaceuticals, Diabetes, Clinical Operations
Education
Kaplan University
MPH, Health Sciences
Ocera Therapeutics August 2015 - Present
UCB September 2012 - August 2015
UCB October 2007 - August 2012
UCB October 2006 - September 2007
UCB March 2005 - October 2006
Biostratum, Inc. October 2001 - March 2005
Medco / King Pharmaceuticals R&D, Inc. August 1999 - October 2001
Jacobs Sverdrup 1989 - 1999
Skills
Biotechnology, Pharmaceutical Industry, Clinical Trials, Clinical Research, Clinical Development, Drug Development, FDA, GCP, ICH-GCP, Protocol, EDC, Regulatory Submissions, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, Clinical Monitoring, Therapeutic Areas, Infectious Diseases, Oncology, CRO, Medical Writing, CTMS, 21 CFR Part 11, Immunology, Biopharmaceuticals, Diabetes, Clinical Operations
Education
Kaplan University
MPH, Health Sciences
Sharad Bajaj's Ocera Therapeutics Experience April 2014 - Present
Job Senior Manager, SEC and Accounting at Ocera Therapeutics
Industry Accounting
Experience
Ocera Therapeutics April 2014 - Present
Rocket Fuel Inc. April 2012 - March 2014
Amyris Inc. September 2008 - April 2012
Lautze and Lautze July 2004 - January 2008
Patel and Associates January 2004 - July 2004
Skills
GAAP, Financial Reporting, Quickbooks, Accounting, Auditing, Fixed Assets, SAP, General Ledger, Financial Accounting, Reconciliation, Variance Analysis, Cash Flow, Consolidation, US GAAP, Cash Management, Revenue Recognition, Sarbanes-Oxley Act, ERP, Financial Analysis, Finance, Account Reconciliation, Internal Controls, Corporate Finance, SEC filings
Education
California State University-East Bay 2001 — 2003
BS, Accounting and Finance
Ocera Therapeutics April 2014 - Present
Rocket Fuel Inc. April 2012 - March 2014
Amyris Inc. September 2008 - April 2012
Lautze and Lautze July 2004 - January 2008
Patel and Associates January 2004 - July 2004
Skills
GAAP, Financial Reporting, Quickbooks, Accounting, Auditing, Fixed Assets, SAP, General Ledger, Financial Accounting, Reconciliation, Variance Analysis, Cash Flow, Consolidation, US GAAP, Cash Management, Revenue Recognition, Sarbanes-Oxley Act, ERP, Financial Analysis, Finance, Account Reconciliation, Internal Controls, Corporate Finance, SEC filings
Education
California State University-East Bay 2001 — 2003
BS, Accounting and Finance
Jeffrey Bornstein's Ocera Therapeutics Experience March 2009 - November 2010
Job Senior Medical Director at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec September 2014 - Present
Gilead Sciences, Inc November 2010 - September 2014
Ocera Therapeutics March 2009 - November 2010
Tioga Pharmaceuticals 2006 - 2009
Elan 2003 - 2006
Duke University Medical Center 2000 - 2002
Skills
GCP, Cancer, Medical Devices, Oncology, Lifesciences, Clinical Development, Clinical Research, Pharmaceutical Industry, Biotechnology, Medical Affairs, R&D, Biochemistry, CTMS, Clinical Trials, Molecular Biology, Immunology, Infectious Diseases
Education
Duke University
Fellowship, Gastroenterology / Hepatology
McGill University
Doctor of Medicine (MD)
Biogen Idec September 2014 - Present
Gilead Sciences, Inc November 2010 - September 2014
Ocera Therapeutics March 2009 - November 2010
Tioga Pharmaceuticals 2006 - 2009
Elan 2003 - 2006
Duke University Medical Center 2000 - 2002
Skills
GCP, Cancer, Medical Devices, Oncology, Lifesciences, Clinical Development, Clinical Research, Pharmaceutical Industry, Biotechnology, Medical Affairs, R&D, Biochemistry, CTMS, Clinical Trials, Molecular Biology, Immunology, Infectious Diseases
Education
Duke University
Fellowship, Gastroenterology / Hepatology
McGill University
Doctor of Medicine (MD)
Jeri Hilleman's Ocera Therapeutics Experience September 2013 - June 2014
Job
Industry
Experience
Intersect ENT June 2014 - Present
XenoPort January 2004 - Present
Ocera Therapeutics September 2013 - June 2014
Amyris Inc January 2008 - June 2012
Symyx Technologies June 1997 - June 2007
Geron July 1992 - June 1997
Cytel Corporation November 1987 - July 1992
Skills
Financial Analysis, Due Diligence, Biotechnology, Sarbanes-Oxley Act, SEC filings, Start-ups, Finance, Corporate Finance, Cross-functional Team..., Debt, Financial Modeling, Forecasting, IPO, Private Equity Funding, SEC Filings, Strategy, US GAAP, Venture Capital
Education
Brown University
AB, History, Medical Science Program
University of Pennsylvania - The Wharton School
Master of Business Administration (MBA)
Intersect ENT June 2014 - Present
XenoPort January 2004 - Present
Ocera Therapeutics September 2013 - June 2014
Amyris Inc January 2008 - June 2012
Symyx Technologies June 1997 - June 2007
Geron July 1992 - June 1997
Cytel Corporation November 1987 - July 1992
Skills
Financial Analysis, Due Diligence, Biotechnology, Sarbanes-Oxley Act, SEC filings, Start-ups, Finance, Corporate Finance, Cross-functional Team..., Debt, Financial Modeling, Forecasting, IPO, Private Equity Funding, SEC Filings, Strategy, US GAAP, Venture Capital
Education
Brown University
AB, History, Medical Science Program
University of Pennsylvania - The Wharton School
Master of Business Administration (MBA)
franck rousseau's Ocera Therapeutics Experience July 2013 - October 2014
Job at
Industry Biotechnology
Experience
FR-consulting October 2014 - Present
Ocera Therapeutics July 2013 - October 2014
Ocera Therapeutics July 2013 - October 2014
Tranzyme Pharma October 2011 - June 2013
FR Consulting September 2010 - October 2011
Gilead Sciences March 2007 - April 2010
Gilead Sciences July 2003 - March 2007
Triangle Pharmaceuticals September 2002 - July 2003
Triangle Pharmaceuticals July 1999 - September 2002
Triangle Pharmaceuticals March 1997 - July 1999
Skills
Clinical Development, Clinical Trials, Infectious Diseases, Drug Development, Biotechnology, Pharmaceutical Industry, Lifesciences, Regulatory Affairs, Immunology, IND, Therapeutic Areas, Virology, Clinical Pharmacology, Gastroenterology, Epidemiology, GCP, Clinical Research, Medical Affairs, Medicine, Regulatory Submissions, CRO, Drug development, Life Sciences
Education
Université Denis Diderot (Paris VII) 1977 — 1985
M.D
FR-consulting October 2014 - Present
Ocera Therapeutics July 2013 - October 2014
Ocera Therapeutics July 2013 - October 2014
Tranzyme Pharma October 2011 - June 2013
FR Consulting September 2010 - October 2011
Gilead Sciences March 2007 - April 2010
Gilead Sciences July 2003 - March 2007
Triangle Pharmaceuticals September 2002 - July 2003
Triangle Pharmaceuticals July 1999 - September 2002
Triangle Pharmaceuticals March 1997 - July 1999
Skills
Clinical Development, Clinical Trials, Infectious Diseases, Drug Development, Biotechnology, Pharmaceutical Industry, Lifesciences, Regulatory Affairs, Immunology, IND, Therapeutic Areas, Virology, Clinical Pharmacology, Gastroenterology, Epidemiology, GCP, Clinical Research, Medical Affairs, Medicine, Regulatory Submissions, CRO, Drug development, Life Sciences
Education
Université Denis Diderot (Paris VII) 1977 — 1985
M.D
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY