Jose Juan Galvez
Adamstown,MD
Summary
Dynamic and strategic-thinking Physician Informaticist with 26 years of diverse experience spanning informatics, medicine, research, and federal service, including the last four years as Deputy Director for the Office of Strategic Programs / Center for Drug Evaluation and Research (CDER) / FDA, overseeing every aspect of IT while collaborating with government and industry colleagues to fulfill CDER's regulatory mission.
Overview
26
26
years of professional experience
Work History
Deputy Director
Office of Strategic Programs (OSP) / Center for Drug Evaluation and Research (CDER) / Food and Drug Administration (FDA)
2019.10 - Current
- Within FDA, CDER’s mission is to ensure that safe and effective drugs are available to improve health and general well being of the public
- Within CDER, OSP is charged with supporting the Center Director and other Super Office Directors with regulatory oversight of human drugs
- OSP's functional capabilities include strategic planning and management, negotiation with major external stakeholders over future work commitments and resource commitments, and process and program design and management
- The office leads plans and implements CDER’s major IT investments, manages regulatory standards for the agency, provides data and analytics services, and services an internal consulting function for other Super Offices providing programmatic and best practices support
- As Deputy Director, my primary function is to support the Office Director
- I provide leadership to staff performing program planning, analytical and evaluative work, informatics and governance, contributing to the improvement and modernization of CDER’s programs, services, and activities
- Share fully in the duties and responsibilities of the Director
- With the director set strategic goals and direction for the office including IT strategic goals objectives and direction for the Center
- With the Director, I oversee an annual budget of approximately $200M, and about 180 federal staff across three suboffices
- Select programs and initiatives: Data standards, Data Governance, Data Management and Modernization, FDA Adverse Event Reporting System (FAERS)
Chief, Biomedical Translational Research Informatics (BTRIS)
NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL CENTER (CC) and National Library of Medicine (NLM)
2016.07 - 2019.10
- Senior member of the NIH Clinical Center leadership, charged with steering, building and maintaining the Biomedical Translational Research Information System
- BTRIS is the NIH intramural research data repository and clinical data warehouse, and research enabling system serving the NIH research community
- BTRIS allows for aggregation and analysis of data for both primary and secondary use
- The chief coordinates, collaborates with and counsels staff on clinical research and data standards, and conducts primary informatics research
- BTRIS espouses FARE (Findable, Accessible Interoperable, Re-usable) principles, incorporating multiple standards.
Program Director of Clinical & Translational Informatics
CENTER FOR BIOMEDICAL INFORMATICS AND INFORMATION TECHNOLOGY (CBIIT)/National Cancer Institute (NCI)/National Institutes of Health (NIH)
2011.04 - 2016.07
- Within NCI division of NIH, charged with steering clinical informatics projects for CBIIT
- In collaboration with program leadership, manage planning, development, and deployment of large software development projects, focusing on integrated and responsive approaches to addressing clinical and translational challenges in cancer research
- Establish program priorities and determine standards, criteria, and direction for information management, regulatory, imaging informatics, and clinical information modeling projects affiliated with intra/extra mural programs
- Directly manage four federal staff and indirectly supervise 100 contractors; coordinate and counsel federal/contract staff on clinical, basic research, standards, and imaging domains
- Maintain stakeholder relationships while acting as key liaison between clinical/research teams and IT/informatics staff and driving collaborative engagements with government agencies, including FDA.
Senior Clinical Informaticist
Center for Biomedical Informatics/National Heart, Blood, & Lung Institute (NHLBI)/NIH
2010.02 - 2011.03
- In a contract role through Paragon Technologies (Vienna, VA), delivered senior-level assistance to the program Director while acting as a biomedical subject matter expert
- Interfaced with customers and stakeholders to steer the translation of IT goals to actionable plans and tangible projects; managed project requirements definition, development, and launch
- Advised intramural and extramural research colleagues and served as a conduit between technical IT/intramural programmatic staff and clients.
Director of Bioinformatics/Assistant Professor of Pathology/Director of Electron Microscopy
Center for Comparative Medicine, University of California, School of Medicine
2000.07 - 2010.01
- Directed the Bioinformatics Program within the Center for Comparative Medicine, a cross-disciplinary program serving the School of Medicine and School of Veterinary Medicine
- Managed a four-person staff
- Provided leadership to center faculty in information management and representation issues
- Optimized existing and led efforts for purchasing new technologies
- Provided instruction to medical students and postdoctoral-level students in pathology and informatics within the Department of Pathology and Laboratory Medicine
- Managed the electron microscope lab, a shared resource across the school of medicine.
Director of Anatomic & Clinical Pathology/Chief Information Officer
International Tele-Pathology Group
1998.07 - 2000.06
- Onboarded to direct and oversee the activities of the telepathology practice supporting multiple offices among the medical group
- Managed all anatomic pathology and hospital frozen sections
- Supervised the clinical lab and blood bank
- Performed all hospital bone marrow biopsies.
Education
Doctor of Medicine -
University of California, Davis, School of Medicine
Davis, CA1993
Bachelor of Science, Biochemistry -
University of California, Los Angeles
Los Angeles, CA1989
Medical License (in good standing, currently in retirement) -
State of California
Skills
- Strategic Planning
- Change Management
- Program Management
- Program implementation
- Program Oversight
- Budget Development
- Stakeholder engagement
- Staff Development
- People Management
- Verbal and written communication
- Operations Management
- Data Management
Residency And Training
- University of California, Davis, School of Medicine, Pathology Resident, 1993-1998
- University of California, Davis, School of Medicine, Informatics Fellow, 1996-1997
Leadership Experience
- Data Standards Advisory Board, 2022 to present
- Vulcan HL7 accelerator Steering Committee, 2021 to present
- Clinical Center Information Technology Advisory Group, 2016 to present
- Biomedical Research Integrated Domain Group Steering committee, 2015 to present
- HL7 Biomedical Research and Regulation subcommittee, 2015 to present
- Scientific Management Working Group, 2012 to 2012
- NHLBI Extramural Clinical Architecture Steering Committee, 2010 to 2011
- Mutant Mouse Regional Resource Center (MMRRC) Informatics Subcommittee, 2005 to 2010
- Mouse Models of Human Cancer Consortium Informatics Subcommittee, 2005 to 2010
- Technical Advisory Board, Aperio Technologies, 2009 to 2010
Software Proficiencies
Windows, Mac OSX, Linux, MS Office (Word, Excel, Access), PostgreSQL, Oracle, Apache, Enterprise Architect, Aperio, Python SQL, Java, PHP, SQL, Perl
Awards
- NIH Clinical Center CEO Award, 2018, Imaging Coordination with BTRIS
- UCDavis Health Department of Pathology and Laboratory Medicine, Distinguished Alumnus Award for Recognition of Leadership in Biomedical Informatics, 2017
- NIH Award of Merit for Clinical Trial Repository Collaboration with FDA, 2014
- NCI Director’s Award: Marker Nomenclature and Database Committee for the Clinical Trials Reporting Project (CTRP), 2012
- NHLBI Star Award, 2010
Publications
- Structured Reporting in Anatomic Pathology for Co-clinical Trials: The caELMIR Model, Cold Spring Harbor Protocols, 2014, 10.1101/pdb.top078790
- Quantitation of Fixative-Induced Morphologic and Antigenic Variation in Mouse and Human Breast Cancers, Laboratory Investigation: a Journal of Technical Methods and Pathology, 2013, 10.1038/labinvest.2013.10
- The Tumor Pathology of Genetically Engineered Mice: A New Approach to Molecular Pathology, The Mouse in Biomedical Research: Experimental Biology and Oncology, 2006, Elsevier, Inc.
- Microwave Mechanisms – The Energy/Heat Dichotomy, Microscopy Today, 2004, 18-23
Timeline
Deputy Director
Office of Strategic Programs (OSP) / Center for Drug Evaluation and Research (CDER) / Food and Drug Administration (FDA)
2019.10 - Current
Chief, Biomedical Translational Research Informatics (BTRIS)
NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL CENTER (CC) and National Library of Medicine (NLM)
2016.07 - 2019.10
Program Director of Clinical & Translational Informatics
CENTER FOR BIOMEDICAL INFORMATICS AND INFORMATION TECHNOLOGY (CBIIT)/National Cancer Institute (NCI)/National Institutes of Health (NIH)
2011.04 - 2016.07
Senior Clinical Informaticist
Center for Biomedical Informatics/National Heart, Blood, & Lung Institute (NHLBI)/NIH
2010.02 - 2011.03
Director of Bioinformatics/Assistant Professor of Pathology/Director of Electron Microscopy
Center for Comparative Medicine, University of California, School of Medicine
2000.07 - 2010.01
Director of Anatomic & Clinical Pathology/Chief Information Officer
International Tele-Pathology Group
1998.07 - 2000.06
Doctor of Medicine -
University of California, Davis, School of Medicine
Bachelor of Science, Biochemistry -
University of California, Los Angeles
Medical License (in good standing, currently in retirement) -
State of California
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