Toni Waymer

CEO

Washington, DC, United States11 yrs 5 mos experience

Highly StableAI Enabled

Key Highlights

Expert in scaling healthcare operations and clinical research.
Proven track record in regulatory compliance and project management.
Leader in AI-driven healthcare solutions and team collaboration.

Stackforce AI infers this person is a Healthcare Operations and Clinical Research Specialist with a focus on AI integration.

Contact

Skills

Core Skills

Artificial IntelligenceProject ManagementClinical ResearchRegulatory ComplianceBusiness Development

Other Skills

Artificial Intelligence for BusinessAI for LeadershipTeam LeadershipClinical Research DevelopmentBudget and Cost ManagementMulti-country Clinical OperationsFederal ProgramsContract RequirementsAttention to DetailProblem SolvingStrategyChange ManagementScope ManagementProject Management Office (PMO)Management Professional

About

Leaning technology forward with human-centered design and thoughtful execution, I help organizations build systems and workflows creating productive operations during varying stages of growth. I bring a disciplined, solution-driven approach to scaling operations. My extensive experience leading teams and collaborating with stakeholders, empowers my clients while navigating the regulatory rich environment of healthcare and clinical research in way that adds value and efficiency to the process.

Experience

The ai upskilling lab

The Upskilling Lab Pod Leader and AI Fellow

Jul 2025 – Present · 9 mos · Washington, District of Columbia, United States · Hybrid

Of the 200+ applicants, I was selected to participate in the inaugural cohort at the AI Upskilling lab. This 12-week learning by doing project is designed to provide professionals with experiential learning using AI to design products and solving problems.
I am leading a cross-functional team designing an AI powered platform prototype that we will unveil October 21st during DC Startup and Tech week.

Artificial Intelligence for BusinessAI for LeadershipProject ManagementTeam LeadershipArtificial Intelligence

Dlh corporation

Technical Program Manager

Jun 2014 – Present · 11 yrs 10 mos · Bethesda, MD

Demonstrated solution-driven approach to build and sustain clinical research infrastructure globally to rapidly develop high quality clinical trials that improves health outcomes. Extensive experience leading teams and collaborating with stakeholders to navigate the clinical development process globally.
CORE COMPETENCIES
Multi-country Clinical Operations | Clinical Research Development | Regulatory Compliance | Budget and Cost Management
THERAPEUTIC EXPERIENCE
SARS CoV-2 (COVID-19) | Sexually Transmitted Infections | HIV/AIDS | Oncology
DEVICE EXPERIENCE
Point of Care Device | Laboratory Assay Validation
TRIAL DESIGNS
Adaptive Platform | Pivotal | Invitro Diagnostic | Assay Validation | Double-Blind | Triple Blind | Phase I-III
REGULATORY
IND | Dual CLIA Waiver 510(k) Submission | IDE | NDA Submission Package Preparation

Regulatory ComplianceClinical Research DevelopmentBudget and Cost ManagementMulti-country Clinical OperationsClinical Research

Social & scientific systems, inc.

Program Manager

Aug 2011 – Feb 2014 · 2 yrs 6 mos · Silver Spring, Maryland, United States · On-site

Directed the team of seven of the Clinical Trials Network’s Leadership and Administrative Group
Collaborated key stakeholders on research and scientific objectives for studies in Africa and Asia
Collaborated with Director to set, manage, and meet network’s goals
Liaison between senior management and team; Key contact for research coordinating center clients.
Oversight of in-Country Community Advisory Boards; Network Communications and Messaging
Developed inter-network Investigator Financial Disclosure Process. Reduced review time 67%.

Llucas corporation

Director

Jun 2008 – Aug 2011 · 3 yrs 2 mos · Washington D.C.

Develop and Direct Company vision strategic client relationships, business development, and successful implementation of client requests.
Managed National Cancer Institute New Drug Application Submissions Support for Commercial pharmaceutical companies
Program Manager for Environmental Protection Agency, Office of Water, Federal Register Public Response
Business Development

Federal ProgramsContract RequirementsBusiness DevelopmentRegulatory Compliance

Cancer therapy evaluation program (ctep), pharmaceutical management branch (pmb) (contractor)

Project Director

Sep 2002 – Jun 2008 · 5 yrs 9 mos · Rockville, MD

Developed and Directed a $7.5 million budget and staff of 19 to ensure compliance of FDA regulatory requirements to distribute biological and oncology agents for IND clinical trials for the National Cancer Institute (NCI) in five (5) Program Areas:
Project Management
Inventory Control and Management of 40 active drugs or biological agents
Execution of Drugs/Biologics Orders shipped domestically and internationally for 1200 IND CTEP studies
Provide Oversight of Experimental Agents Expanded Access and Compassionate Use Program Team
Maintain 40,000 investigator files and hundreds of drug and biological agent files
Advised client of best practices. Improved staff performance, productivity and response time of pharmacy deliveries

Federal ProgramsContract RequirementsProject ManagementRegulatory Compliance