Carlisha Gentles,PharmD
Atlanta,GA
Summary
Innovative healthcare professional and scientist specializing in public health and equity, recognized for exceptional productivity and efficient task execution. Proficient in pharmaceutical sciences, project management, leading teams, and program development, with strong critical thinking, problem-solving, and collaboration capabilities in dynamic settings. Committed to continuous improvement and adept at mastering new skills independently. Demonstrates a robust work ethic, adaptability, and outstanding interpersonal abilities.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Health Scientist
Center for Disease Control and Prevention (CDC)
Atlanta, USA
04.2022 - Current
- Senior health scientist serving as a Scientific Review Officer (SRO) for the Extramural Research Program Operations (ERPO)
- Formulating and administering plans, HHS, and CDC policies, and procedures related to conducting merit peer review
- National impact on public health programs for injury and violence prevention, environment health, and toxicology through consultation with national center senior staff, agency staff and the scientific community
- Leads and conducts activities for primary scientific peer review activities of extramural research grants and cooperative agreements for CIOs that the office supports, which includes among other work, recruiting scientists with expertise in injury and violence prevention, environmental health and toxicology program areas to serve as potential reviewers
- Works closely with the Scientific Program Officer, ERPO Director, other ERPO staff, internal division and office staff, external scientists, and other offices to lead and execute peer review program activities in accordance with CDC Policy for peer review, HHS Policies for federal advisory committees, established ERPO and other partner office procedures
- Led 4 national special emphasis panels and recruited 176 experts to serve on panels resulting in the selection of the most meritorious applications for the awarding of $38 million in grant funding
- Co-authored communication to increase diversity of research applicants & SMEs from minority serving institutions distributed to 12,000+ stakeholders
- Cross-trained as a grants technical assistant to fill a critical gap on her team for 90 days, requiring significant coordination & collaboration which ensured a smooth grantee selection process & distribution of $8.5 million in grants for violence & opioid overdose prevention
Advanced Practice Pharmacist
Community of Hope
Washington, USA
10.2017 - 06.2024
- Delivered chronic disease management services as a medically credentialed pharmacist to underserved populations.
- Utilized strong communication skills to translate evaluation findings for non-technical audiences, aiding executive leadership in data interpretation.
- Collaborated with District of Columbia Board of Pharmacy and Department of Health Care Finance to identify initiatives that enhance clinical pharmacy service delivery.
Senior Risk Management Analyst
Food & Drug Administration (FDA)
Silver Spring, USA
09.2018 - 04.2022
- Scientific analyst for the review and implementation of risk mitigation strategies for NMEs in the areas of cardiovascular and renal, psychiatric, reproductive, hematology and oncology, metabolic and endocrine, and anti-infective products.
- Scientific lead for determining whether safety issues that are drug-related and identified in the postmarketing period warrant consideration of a REMS
- Provide high-level advice on REMS issues to industry partners during formal meetings
- Keep fully abreast of all crucial and precedent-setting risk management issues and related activities within FDA and in regulated industry
- Maintain a comprehensive understanding of the full range of Center regulatory policies, programs, and procedures, expert knowledge of the statues and regulations enforced by the Agency, and personal observation and experience with many sources both within and outside the Agency
- Led team in development of complex Fenella REMs (medication safety program) under compressed congressional mandates, expanding treatment for a rare life-threatening epilepsy impacting 54,000 infants & adults nationally. Received CM and FDA Honor Award for this accomplishment.
Senior Regulatory Management Officer
Food & Drug Administration (FDA)
Silver Spring, USA
11.2014 - 09.2018
- Important Serves as a senior-level regulatory management officer for Office of Generic Drugs (OGD) within the Division of Bioequivalence III (DBIII)
- Assists the Division by serving as the Consults Coordinator for the entire Division of Bioequivalence
- Serves and performs the duties and responsibilities as the acting supervisor in the absence of the supervisory project manager (SPM) or project manager team lead (PMTL)
- Reviews administrative, legal, and scientific aspects of Abbreviated New Drug Application (ANDA) submissions
- Responsible for control and coordination of the review of all ANDA submissions in group from initial receipt to action completion
- Review, analyze, and write discipline specific reviews for: Dissolution acknowledgements for ANDAs, Qualitatively (Q1) and Quantitatively (Q2) injectable ANDAs
- To solve subtle, obscure problems and resolve new emerging problems during an office wide reorganization, where judgments made may often set precedents for subsequent regulatory action or in industry practices
- Contribute to the development and improvement of Division of Bioequivalence processes by collecting and providing data to Management to determine distribution of workflow for efficiency
- Serves as a liaison between regulatory project managers (RPMs) and FDA reviewers for discipline inquiries
- Determine that all scientific reviews are present and that all issues are resolved prior to approval or disapproval
- Ensures that all outgoing correspondence is consistent with laws and regulations
- Initiates administrative action whenever the facts reveal significant deviations from the requirements of the law or regulations
- Assists in the training and day to day supervision of trainee and junior-level regulatory management officers
- Schedule group meetings with reviewers and team leaders about issues with related ANDAs and address concerns from directors
- Coordinate and document meetings and teleconferences, respond to drug application and regulatory questions and concerns, and prepare official written responses to the industry
- Communicate application deficiencies related to Bioequivalence, Biopharmaceutics (Dissolution), and Protocol reviews to industry via Easily Correctible Deficiencies (ECD) and Information Requests (IR)
- Track responses of ECD's and IRs to ensure timely distribution of assignments in order to allow reviewers the maximum time to review a submission
- Create data reports using Microsoft Excel (pivot table, various charts, conditional formatting, etc.) to measure Generic Drug User Fee (GDUFA) metrics
- Present findings of reports and projected trends, and proactively propose changes in policy in order to meet deadlines and surpass goals
- Identify and request inspection for bioanalytical and clinical sites, if necessary, for Office of Study Integrity and Surveillance (OSIS)
- Fill in as interim Division of Bioequivalence II Project Manager Team Leader when needed
- Fill in as Immediate Office Senior Supervisory Project Manager when needed
- Managed 12 reviewers aiding in the approval of 65 generic drug applications & 5 notable 1st generics
- Assisted as SME with development of MAPP 5220.4: Consult Processes in the Office of Generic Drugs for Industry
Chief Pharmacist
Indian Health Services
Tsaile, USA
10.2012 - 11.2014
- Manage administrative aspects of the pharmacy department
- Create annual budget and monitor departmental financial obligations, develop annual quality monitors to track the clinical success of the department, responsible for drug procurement and inventory, file management, controlled substance accountability, supervise and train two pharmacy technicians and two pharmacists, maintain readiness for routine inspections by quality improvement personnel and JCAHO
- Designated Pharmacy as a worksite for the Navajo Nation Workforce Development Program and provide oversight of student workers
- Purchase narcotics using DEA CSOS program, manage inventory, maintain compliance with federal and state regulations, and assure appropriate records management.
- Direct Patient Care
- 60% of weekly time constitutes direct patient care and prescription processing services, provide drug information services to staff and patients, process non-formulary drug requests, address patient satisfaction and departmental customer service issues
- Chronic Disease Management Program Coordinator
- Local and nationally credentialed pharmacist-provider effectively managing Native American patients with uncontrolled diabetes, hypertension and dyslipidemia in a collaborative team model
- Utilized strong communication skills to aid in translating findings of this evaluation project for non-technical audiences, therefore helping executive leadership understand and interpret the data to support necessary changes to improve the performance of this program
- Collaborated with the service unit's Diabetes Improvement Committee and Special Diabetes Programs for Indians (SDPI) Healthy Heart Initiatives to utilize grant funding in establishing a pharmacist-managed clinic
- Utilized subject matter expertise with Arizona AHCCCS and Medicare Part D programs to integrate Medication Therapy Management (MTM)
- Established Memorandum of Understanding with Mirixa and Outcomes to provide MTM services for Medicare Part D patients in Indian Country
- Led successful effort in Indian Country to implement a collaborative practice agreement focused on treating Native American patients with uncontrolled Diabetes, Hypertension and Dyslipidemia increasing access to care for approximately 168,000 patients
- Addressed public health issue by re-establishing pharmacist-driven immunization program within our service unit which includes 3 sites
- Presented locally to the service unit IPC collaborative meeting on 'Lions, Pharmacists, and Metformin…Oh My' which detailed a new initiative of pharmacists at Tsaile Health Center adjusting diabetic medications for patients
Advanced Practice Pharmacist
Indian Health Services
Tsaile, USA
08.2011 - 10.2012
- Provided patient-specific pharmaceutical care through outpatient chart review and screening for appropriateness of drug therapy, and patient counseling to ensure understanding of the purpose, proper use, and appropriate outcomes of their medications
- Responsible for monthly monitoring of outdated medications of assigned stock shelves to ensure control and availability of medications
- Prepared extemporaneously compounded medications for special patient populations as needed
- Consulted providers concerning clarifications on drug therapy, document interventions, and provide drug information to other health care providers
- Assisted in the supervision of pharmacy technicians, students, and volunteers
- Provided personalized patient care and counseling to patients on medical conditions, drug interactions, and the efficacy of over-the-counter medications
- Demonstrated and illustrated use of the Indian Health Service Standards of Care Model to provide pharmaceutical care to the Navajo Native American population
- Collaborated with physicians and other healthcare providers to assist with the management of patients' conditions to achieve optimal health outcomes
- Served as a drug information resource for patients and healthcare providers
- Prevented, detected, monitored, documented, and reported adverse drug reactions and medication errors
- Implemented a Medication Therapy Management to help patients get the best benefits from their medications by actively managing drug therapy and by identifying, preventing, and resolving medication-related problems
- Developed a laboratory standing order whereby pharmacists would be able to order pertinent laboratory measures to make thebest therapeutic recommendation
- Precepted pharmacy students from four colleges of pharmacy across the United States. Precepted an average of 10 students per year
Education
ASHP PGY-1 Pharmacy Residency - Community Practice & Ambulatory Care
Mercer University
Atlanta01.2009
Doctor of Pharmacy -
Howard University College of Pharmacy
Washington01.2008
Skills
- Public health initiativesScientific review
- Grant management
- Regulatory compliance
- Data analysis
- Policy development
- Risk assessment
- Team collaboration
- Stakeholder engagement
- Communication skills
- Project management
- Problem solving
- Diversity initiatives
- Chronic disease management
- Clinical pharmacy
- Expert recruitment
- Research and publication
- Peer reviews
- Self-directed and motivated
- Excellent communication
- Decision-making
- Quality improvement
Certification
- Board Certified Pharmacotherapy Specialist (BCPS), BPS, 12/31/12, 12/31/26
- Certified Diabetes Care and Education Specialist (CDCES), CBDCE, 12/31/13, 12/31/27
- Associate in Project Management from George Washington University, 2015
- Lean Six Sigma Practitioner Certification, 2015
- Immunization Delivery Certification, 2008
Awards
- USPHS Commendation Medal, 2021
- City of Thomaston Black History Award Honoree, 2023
Publications
- Hamilton, N., Hunter, C., Gentles, C. Extramural Funding Announcement Handout. CDC National Center for Injury Prevention and Control. November 2023.
- Gentles, C. Breastfeeding Awareness Fact Sheet. BCOAG Newsletter. August 2023.
- Gentles, C. National Minority Health Month Article. BCOAG Newsletter. April 2023.
- Robinson, R., Young, A., Van Lew, H., Gentles, C., and Urena, C. Pandemic Response in Alaska: Preparing Pharmacists to Lead Vaccination Efforts. Journal of American Pharmacists Association. December 2022.
- Gentles, Carlisha. Feature in Women’s Month. Thomaston Times. March 2020.
- Wright, J. Gentles, C. Ward Infinity Participants Offer Solutions to Health Issues. Washington Informer. July 2019.
Career Summary
Senior Health Scientist, CDC, Atlanta, GA, O-6, 04/06/22 - present, Senior Risk Management Analyst, FDA, Silver Spring, MD, O-5, 09/18/18 - 04/05/22, Senior Regulatory Management Officer, FDA, Silver Spring, MD, O-5, 11/14/14 - 09/17/18, Chief Pharmacist, IHS, Tsaile Health Center, Navajo Reservation, Tsaile, AZ, O-5, 10/09/12 - 11/13/14
Presentations
COVID-19 Vaccine Hesitancy, COF-USPHS Symposium, 05/2022
References
References available upon request.
Timeline
Senior Health Scientist
Center for Disease Control and Prevention (CDC)
04.2022 - Current
Senior Risk Management Analyst
Food & Drug Administration (FDA)
09.2018 - 04.2022
Advanced Practice Pharmacist
Community of Hope
10.2017 - 06.2024
Senior Regulatory Management Officer
Food & Drug Administration (FDA)
11.2014 - 09.2018
Chief Pharmacist
Indian Health Services
10.2012 - 11.2014
Advanced Practice Pharmacist
Indian Health Services
08.2011 - 10.2012
ASHP PGY-1 Pharmacy Residency - Community Practice & Ambulatory Care
Mercer University
Doctor of Pharmacy -
Howard University College of Pharmacy
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