Deputy Director of Research at the DoD’s premier Combat Casualty Care (CCC) research facility. Responsible for over 335 laboratory research personnel and oversight of $55M in S&T programs (cost, schedule and performance) for over 100 funded proposals. Implements and enforces Army and Command programs focusing on EO/EEO, safety, mentorship, management controls, educational outreach, and maintaining an Army Strong workforce. Manages day-to-day operations in a research laboratory setting, routinely briefs senior leaders, provides strategic and operational planning, conflict resolution, and staffing management. Supports the implementation of the Director of Research’s vision for CCC, by anticipating, planning, and successfully managing organizational change. Related Skills:Leadership; Counseling; Supervisory; Performance Appraisals; Professional Development; Mentorship; Removals; AATAPS management; Manpower; Re-organization; Change Management; Conflict Resolution; Strategic Communication; Staffing Decisions; Positions Description Review; Dignitaries, and Flag Officer Tours; Cost, Schedule and Performance (Research Projects); R programming, RShiny; SAS programming, Clinical Research; Basic and Applied Research; Biostatistics; Clinical Trial Support; Microsoft Word; Microsoft PowerPoint; Microsoft Excel; and Departmental SharePoint Administration.Accomplishments: (1) Designed, created, managed, and drove the organization to adopt SharePoint for project management, budgetary management, strategic communication, and day-to-day operations.(2) Re-organized the Research Directorate from 15 departments and 4 divisions into 6 Physiological-Based Pillars. Used data science approach to analyze, manage and execute reorganization. (3) Optimized staffing to overcome $7M in budgetary shortfalls, consolidated services, established cost-reimbursable support services, and managed cost, schedule, and performance.

Department of Preventive Medicine & Biometrics

Serves as Director, Office of Regulated Activities (ORA), leads and ensures professional development of 68 regulatory and compliance professionals, oversight of $12M budget, and the cost, schedule, and performance of 22+ regulatory support agreements, encompassing 81 OTSG-sponsored and 25 non-OTSG-sponsored FDA-regulated medical products. Serves as a member of the Product Lifecycle Review Committee (PLRC), responsible for strategic regulatory advice across the medical product lifecycle. Sustains strategic, innovative, affordable, reimbursable regulatory support services, encompassing regulatory affairs (biologics, devices, and drugs), regulatory operations, clinical operations, data management, biostatistics, product technical operations, product safety and surveillance, and quality. Ensure ORA's policies, programs, initiatives, and processes adequately address the Food and Drug Agency Sponsor's responsibilities.Related Skills:AATAPS management, Manpower, Counseling, Supervisory, Change Management, Conflict Resolution, Cost, Schedule and Performance of regulatory efforts related to Products, R programming, SAS programming, Clinical Research, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, SharePoint Administration, Strategic Communication, Performance Appraisals, Re-organization, Staffing Decisions, Positions Description Review, Professional Development, Strategic Planning, Mentorship, Removals, Dignitaries, Flag Officer Tours.Key Accomplishments in this position:(1) Brought about the organization to adopt SharePoint to manage many administrative tasks. Designed, created, managed, and exploited the use of SharePoint, and drove the organization to utilize for project management, budgetary management, strategic communication, and day-to-day operations.(2) Action Officer that led the regulatory reengineering effort, which resigned the Office and moved it from USAMMDA to higher headquarters. (3) Developed 1st-regulated Activities Handbook for the command.

Lead the Office of Regulated Activities (ORA) Business Support Office. Responsible for the safety, security and professional development of fourteen staff, data systems used to in operations for over $13M in product support. Exercise cost, schedule, and performance oversight of the regulatory support agreements for FDA-regulated medical products within five Project and 18 Product Management Office, for 82 OTSG-sponsored medical products and more than 25 non-OTSG-sponsored products. Lead the strategic Regulatory Reengineering and movement of ORA from USAMMDA to USAMRMC to include the strategic plan, new financial model, and reorganization tasks. Collaborate with business office staff and ORA technical branches to establish a continuity book of standard operating procedures for all ORA activities. Intern with Devices & Diagnostics to develop subject matter expertise in device submissions related to software applications. Provide regulatory support to the Advanced Medical Monitoring (AAM) Integrated Product Team (IPT), and the APPRAISE hemorrhage detection product.Related Skills:AATAPS management, Change Management, Conflict Resolution, Cost, Schedule and Performance of regulatory efforts related to Products, R programming, SAS programming, Clinical Research, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, SharePoint Administration, Strategic Communication, Performance Appraisals, Re-organization, Staffing Decisions, Planning, Positions Description Review, Professional Development, Mentorship.Key Accomplishments in this position:(1) Developed an 88-page concept plan to create the Office of Regulated Activities, including the re-organization, new contracting mechanisms, and staffing model to implement a cost-reimbursable model (one of the first successful offices to become reimbursable at HQ).(2) Action officer for the initial operational capability for the newly created Office of Regulated Activities.

As a fellow, contributed primary to (I) regulatory challenges with the approval of drugs for traumatic brain injury, and (2) development of knowledge management tools to facilitate regulatory decision making. For TBI, completed an extensive evaluation of clinical trial design elements, effectively summarized findings, and engaged with OND's review division for TBI products for guidance, feedback, and information. For knowledge management, applied informatics and coding experience to create a novel web-based application to address critical gaps in regulatory science, and enable FDA users to search and identify pre- and post-market drugs indicated for standardized disease terminology. Routinely briefed and conducted live demonstrations of the capability to all levels of leadership, and contributed to the UCSF-Stanford CERSI Natural Language Processing Workshop and the FDA's Scientific Computing Days (2017) Breakout Session. Among a select few to attend and complete a Certification in the Duke Health Informatics Short Course.Key Accomplishments in this Position:(1) Developed R-Shiny applications to use Natural Language Processing to text mine commercial investigational new drugs, and report findings to Director of CDER.(2) Participated on the R working group and data governance committees at CDER.(3) Investigated key elements of TBI clinical trials.

Serve as Theater Biochemist deployed in the U.S. Army Central Command USARCENT) area of responsibility (AOR) to support Operation Inherent Resolve (OIR) and Operation Spartan Shield (OSS). Provide chemical warfare agents, toxic industrial chemicals and other biohazard materials presumptive surveillance and consultation across the AOR for the protection of over 15,000 USARCENT and US Central Command (USCENTCOM) Service Members, and Civilians at nineteen locations in USARCENT AOR. Collaborate with other deployed units (CBRN company, Forensic Exploitation Laboratory and the Air Force Medical Expeditionary Teams) to illuminate short- or long-term health threats to US assets. Execute the surveillance capabilities of the 227th for presumptive identification of chemical threats among various matrix.Key Activities in this position:Research, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Strategic Communication, Strategic Planning, Force Health Protection, Sustainment, CBRNE, Established Standard Operating Procedures, Surveillance.Key Accomplishments in this position:(1) First to test the Environmental Sentinel Biomonitor (ESB) in a far forward combat zone (Tikrit, Iraq), and conducted user assessments of novel capability and reported results to HQ. Established SOPs, and other technical details to use the capability while deployed.(2) Conducted over 100 site assessments throughout CENTCOM to include a Country-wide Force Health Protection security mission in Afghanistan.(3) First place in-theater Symposium (briefed CENTCOM General Officers on the ESB).

Second in chain of command for the US Army Center for Environmental Health Research, the Army's leading science and technology laboratory in the areas of systems biology and systems toxicology. Responsible for over 47 scientific and support personnel and a research budget in excess of $18M. Provide senior level administration for medical research and product development for systems biology initiatives and, occupational and environmental health surveillance, and environmental health technology in support of Force Health Protection. Implement and enforce Army and Command programs focusing on EO/EEO, safety (achieved Intuition’s first Safety Star), mentorship, management controls, educational outreach, and maintaining an Army Strong workforce. Responsible for Cost, Schedule and Performance for two service contracts.Key Activities in this position:AATAPS management, Counseling, Supervisory, Change Management, Conflict Resolution, R computing, Research, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Strategic Communication, Contracting Officer Representative, Performance Appraisals, Staffing Decisions, Positions Description Review, Professional Development, Strategic Planning, Mentorship, Removals, Dignitaries, Flag Officer Tours.Key Accomplishments in this position:(1) Established new USACEHR strategic communication brochures and pamphlets for dissemination, and SMS (Strategic Management System) strategic plan. Developed plan to update USACEHR website, to include publications, Commander and ST bio pages, SBCC page, and transferred ownership to staff for routine maintenance.(2) Completely updated SMS, all fields entered, tags, description, formulas; BSC excel sheet developed to track fields, Authored SMS FY16 Strategy Plan. GUided SMS from Training status to Live status.(3) Authored new energy and water conservation standard operating procedures, compiled energy use logs. Developed staffing and mission analysis, and revamped safety policies.

Provides strategic leadership and scientific oversight to the Environmental Health Program funded at $8.9 million per year, consisting of $2.5 million in equipment and fourteen research scientists. Directs research to discover and develop candidate biomarkers of adverse health effects related to occupational and environmental hazards that threaten the health of Soldiers. Advances research through increasing technology readiness, establishing transfer agreements for advanced development, and supporting small business innovation research. Establishes integrated research teams and Joint research projects to leverage new funding and collaborations. Co-Chairs the Military Operational Medicine Research Program Environmental Health & Protection Program Area Steering Committee. Vice-Chairs the Institutional Animal Care and Use Committee and directs programmatic changes when necessary to maintain national laboratory accreditation.Key Activities in this position:AATAPS management, Counseling, Supervisory, Change Management, Conflict Resolution, Cost, Schedule and Performance of regulatory efforts related to Products, R programming, Animal Research, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, SharePoint Administration, Strategic Communication, Performance Appraisals, Re-organization, Staffing Decisions, Positions Description Review, Professional Development, Strategic Planning, Mentorship, Removals, Dignitaries, Flag Officer Tours.Key Accomplishments in this position:(1) Developed USACEHR first State of the Science Meeting/Agenda and coordinated with JHU-APL/CPT Dancy, Drs. Ippolito and Lewis for execution.(2) Submitted D3 Innovation Proposal to USAID, of 2 proposals selected from DoD, funded FY16 DHP program (new $5M program).(3) Supported Chem Bio Medical Systems Analysis of Alternatives for the Next generation diagnostic System, Increment II, IPR(4) Established a new Defense Health Program (DHP) proposal to expand the studies on microbiome.

Managed a full animal research program as representative on the IACUC. Ensured high-quality review of research proposal and guided program to achieve its first AAALAC accreditation for rodent and aquatic research. Played key role in the establishment of the institution’s first rodent vivarium.

Second in chain of command for 6 researchers, in support of over $3.5M in funded research projects. Lead, coordinate, and collaborate on all phases of the multicenter heat stroke research program emphasizing integration into the System's Biology Enterprise. Conduct research, evaluate data, identify and justify therapeutic targets and companion diagnostics, generate reports, and prepare presentations. Chair Institutional Animal Care and Use Committee and provide subject matter expertise in vivarium planning, design, policies and procedures. Conduct acquisition training and provide support on research contracts as Contracting Officer's Representative. Provide administrative support to all aspects of the Biomarker Program and attend professional meetings.

Chief of Research Operations Service in the Department of Clinical Investigation. Lead the research efforts of six staff scientists and provide budgetary oversight in excess of $162K. Primary mission is to develop and execute a medical research curriculum that provides mentorship to Graduate Medical Education (GME) residents, fellows, and staff. Provide GME students with subject matter expertise, guidance with proposal development, execution of control experiments, analysis of experimental data, and scientific writing. Conduct intramural research projects focused on translational research and that promote synergism with GME staff and students. Act as full member and provide subject matter expertise to the MAMC Institutional Review Board and Scientific Review Committee.

Support Research Operation's mission by procuring equipment, developing research proposals, and refining medical research protocols in support of Graduate Medical Education (GME). Promote research excellence and provide guidance to GME residents, fellows, and staff. Develop and execute a medical research curriculum that provides mentorship to GME students. Provide subject matter expertise, guidance with proposal development, execution of control experiments, analysis of experimental data, and scientific writing. Act as member and provide subject matter expertise on the MAMC Institutional Review Board. Interface with local community colleges and act as a member on the Bates Scientific Advisory Committee. Conduct intramural research projects that are focused on translational research and promote synergism with GME staff and students.

Graduate Research Assistant.