Our team of seasoned industry veterans can anticipate your study challenges and proactively seek solutions.
Our team of seasoned industry veterans can anticipate your study challenges and proactively seek solutions.
President & CEO
As CEO, Ted FitzGerald drives strategy, innovation, business development and quality in clinical research for the FHI Clinical team. He oversees more than 50 team members across 15 countries who are dedicated to achieving social impact by addressing unmet research needs in dozens of therapeutic areas.
FitzGerald has worked in the areas of clinical research and public health for more than 25 years. He has focused on clinical and medical device research, sexual health test counseling and clinical trial recruitment and retention.
In his previous role as Director, Global Research Services for FHI 360, FitzGerald drove growth of the full-service CRO by building the portfolio of Phase I – IV trials and diversifying service offerings in the US, Africa, Asia, Europe and Latin America. In his more than decade of work for FHI 360, he led clinical research services, business development and administrative teams to ensure a strong pipeline of opportunities aligned with the organization’s mission and capabilities.
Prior to joining FHI 360, FitzGerald served in a variety of senior roles at the American Sexual Health Association, including serving as the Director of New Service Development, a position which involved building new lines of business for the organization.
FitzGerald holds master’s and bachelor’s degrees in materials science from Northwestern University.
Rob King brings more than 30 years of clinical research industry experience to his role as FHI Clinical’s Chief Operating Officer. King has extensive experience in global clinical operations and executive leadership, with a professional and academic focus in quality management and compliance.
King has contributed to consistent double-digit growth at his last four organizations, and he is experienced in leading the acquisition and integration of global CRO and biotech companies. Prior to joining FHI Clinical, he held the position of COO at Asklepios Biopharmacetical, Inc (AskBio), a gene therapy biotech. While there, he oversaw corporate growth, fundraising, integrations and facility expansion to allow for development of six adeno-associated virus (AAV) investigational products.
King also held the position of COO at Novella Clinical (now IQVIA Biotech), an oncology and medical device-focused global CRO. At Novella, he was responsible for global operations and client delivery across 1,500 staff and 52 countries. Prior to joining Novella, King was COO at Health Decisions, a CRO focused on women’s health. At Health Decisions, he oversaw global operations and served as project director for the clinical and statistical coordinating center for the National Institutes of Health-sponsored Contraceptive Clinical Network.
King served for seven years as an Adjunct Professor at Campbell University, lecturing in clinical research, and he continues to serve on the Durham Technical Community College Clinical Trials Research Advisory Committee.
King holds a bachelor’s degree in psychology from the University of North Carolina at Wilmington and is certified in nonprofit management from Duke University.
As Senior Vice President, Clinical Operations, Claudia Christian leads the overall direction and implementation of program execution for all clinical research activities at FHI Clinical. As an executive leader, she supports launch demands, strategic decisions on growth and service offerings, and pandemic response throughout the Americas, Africa and Asia.
Christian has worked in clinical research across multiple indications for more than 25 years. Prior to joining FHI Clinical, she served as Vice President, Global Operations and as Director Strategic Partnerships in subsequent large commercial CROs. She has held multiple positions from fieldwork to management at small and large biopharmaceutical companies, to scaling global clinical trials within niche CRO from phase I-IV, to leading mergers & acquisitions (M&A) strategy and execution.
Christian focuses on managing challenging international markets with a focus on accessibility and sustainably improving lives in resource-constrained settings.
Throughout her career, Christian has successfully participated in senior leadership ownership programs through M&A and was instrumental in developing the commercial pipeline, growing the book of business by 3 times in less than 3 years, completing due diligence and sale well ahead of planned timelines and growing the company valuation by 5 times from inception to point of sale with over 18% growth year over year (YoY) in revenue, a net book to bill of 1.2 (YoY) and gross margin above 26%. At another engagement, Christian managed over $250M in net-based assets YOY through strategic partnerships with a portfolio value of over $750M annually.
Vice President, Global Strategy
With more than twenty years of experience in clinical research monitoring and management, Ghiorghis Belai serves as FHI Clinical’s Vice President, Global Strategy. In this role, Belai is responsible for managing FHI Clinical’s relationships with sponsors and sites, and he works on project feasibility to ensure optimal implementation of trials.
Belai previously served as Director of Clinical Operations for FHI 360, where he managed the clinical research unit based in Nairobi, Kenya, while supervising and mentoring the FHI 360 Africa Regional Clinical Research Unit. In this role, Belai was responsible for reviewing study protocols, coordinating study implementation of multi-center and multi-country trials in Africa, and ensuring that studies adhered to protocol requirements and applicable regulations and guidelines.
With a background in clinical research, Belai has also worked as a clinical research associate for PharmaNet Development Group, Inc., and PPD, where he participated in multiple multi-center clinical research studies, assisted with project data clinical review and management, and presented at investigator meetings for assigned studies. In addition, Belai monitored sites according to applicable standard operating procedures and Food and Drug Administration guidelines and reviewed case report forms for adherence to protocol requirements.
Belai holds a bachelor’s degree in Clinical Laboratory Science from the University of Louisiana at Monroe and a master’s degree in Clinical Research from the University of Liverpool.
Vice President, Business Operations
As Vice President, Business Operations at FHI Clinical, Rebecca Johnson leads the continuous development of infrastructure to support the expanding global portfolio. With an emphasis on managing a strategic team and efficient processes, Johnson oversees the human resources, proposals, information technology, contracts, procurement and marketing functions. She has expertise in continuous improvement initiatives, global business management and team leadership. Her success is driven by an ability to align project and program strategy with business and financial goals through the establishment of effective policies and procedures.
Prior to partnering in the launch of FHI Clinical, Johnson spent eight years at FHI 360 where she directed and oversaw large-scale continuous improvement projects and successfully implemented strategic initiatives through enhanced project management methodologies and reporting systems. Earlier in her career, she worked as a management consultant and also served as a small business development volunteer with the Peace Corps.
Johnson also serves as an Adjunct Professor at Duke University, teaching a masters course on project management with a focus on the complex nature of global projects. She is PMP-certified and holds a bachelor’s degree in Economics from the University of Illinois at Urbana-Champaign and a master’s degree in Policy from Duke University.
As Vice President, Business Development, Jeff Cazeault leads the business development team in driving the expansion of the FHI Clinical’s global sales strategy and portfolio in infectious disease. With a background in global team development and management, strategic partnerships and sales strategy, Cazeault has provided disruptive growth and development in pharmaceutical, biotech, clinical research, healthcare tech, CI/market research and innovative healthcare start-ups for more than 20 years. Cazeault also has extensive experience in the China pharmaceutical market in working with biotech companies in licensing and business development strategy.
Most recently, Cazeault worked as a business development consultant serving biotech clients that included healthcare firms focusing on orphan and rare diseases and healthcare areas of unmet need. Prior to that, Cazeault was Vice President of Business Development at Atlantic Research Group, Inc and his experience also included serving as Head of Global Sales at Eli Global and in various sales leadership roles at Bristol-Myers Squibb Immunology and Boehringer Ingelheim Pharmaceutical.
Cazeault holds a Bachelor’s degree in Psychology from Virginia Wesleyan College and lives with his wife and four children in Wrightsville Beach, NC.
Senior Director, Finance
Alan Hampton has 17 years of Financial Management experience in the hospital and health care industry. As Senior Director, Finance at FHI Clinical, he manages financial activities including project budgeting, reporting and forecasting, while partnering with Business Operations.
Alan previously served as the Associate Director, Finance at FHI 360. Prior to joining FHI 360, he held various positions at Siemens Medical Solutions, INC Research (now Syneos Health) and PPD. He is experienced in budgeting, managerial finance, accounting and financial planning.
Alan served as a Senior Airman in the United States Air Force and holds a bachelor’s degree in Accounting and an MBA from North Carolina State University.
Senior Clinical Strategy Director, Global Strategy
As Senior Director of Clinical Strategy, Joy Toro leads the study feasibility function and drives the operational oversight of tools and systems to support sponsor and site alliances. In addition, she is responsible for the recruitment and oversight of the scientific advisory expert team. With a 15-year background in clinical operations management, Toro brings experience in clinical strategy, team facilitation, field monitoring and training for international project work in resource-limited settings.
Previously, Toro served as the Associate Director of Business Operations at IQVIA Biotech, where she was responsible for a large systems migration and process improvement. Prior to that, Toro was Associate Director of Clinical Operations for North America at Novella Clinical, working with CRA Managers, Clinical Research Associates (CRAs) and Project Management teams to ensure delivery of quality services, standardization and performance across company projects. Toro’s experience also includes Project Manager roles at ICON Clinical Research and FHI 360 with field experience in multi-country trials in Asia and Latin America.
Toro is PMP-certified and holds Bachelor’s degrees in Political Science and Romance Languages from the University of North Carolina at Chapel Hill, Master’s degrees in Trans-Atlantic Studies and Social Work, and a Graduate Certificate in Core Public Health Concepts from the University of North Carolina at Chapel Hill.
Senior Director, Business Development
As Senior Director of Business Development, Niraj is responsible for building client relationships with biotech, pharmaceutical and academic partners in the Eastern half of the United States.
Niraj, a management graduate from India, has over 30 years of sales experience in many different domains, including Information Technology Services, Training and Health Research, globally. He is an effective communicator and relationship builder and has supported all aspects of business operations including business development, proposal support, program management, operations and contract negotiations. In addition, he has supported numerous federal agencies in his career such as the US Department of Health and Human Services (HHS: Centers for Medicare & Medicaid [CMS], Centers for Disease Control [CDC], National Institutes of Health [NIH], Federal Drug Administration [FDA]), the Department of Defense (DoD: US Army Medical Research and Development Command [USAMRMC], Walter Reed Army Institute of Research [WRAIR], Defense POW/MIA Accounting Agency [DPAA], Armed Forces Medical Examiner System [AFMES], Army Public Health Center [APHC], Naval Medical Logistics Command [NMLC], Air Force Research Laboratory [AFRL], Naval Health Research Center [NHRC], Defense Information Systems Agency [DISA], US Army Medical Materiel Agency [USAMMA], US Army Institute of Surgical Research [USAISR], US Army Medical Research Institute of Chemical Defense [USAMRIDC], Military Surface Deployment and Distribution Command [SDDC]), Department of State (DoS), US Agency for International Development (USAID), and the Drug Enforcement Administration (DEA). He most recently served as the Business Development and Capture Manager for the Henry M Jackson Foundation (HJF). Prior to that, he worked for small and mid-size businesses such as IndraSoft, RTGX and New Horizons. Niraj is based in the Washington DC Metro Area, loves to travel and prefers as much face time (in the post-COVID world) as possible with his customers. He is an enthusiastic and quick learner and is keen to help grow FHI Clinical and meet and exceed assigned targets.
As Director of Proposals at FHI Clinical, Peggy Coyle builds partner relationships and manages proposals, budgets, timelines and personnel. In addition to her experience in proposal development, Coyle is a skilled clinical research project manager with experience working in clinical trials management and clinical trials capacity building. Her therapeutic areas of focus include infectious diseases, oncology and early development, and she has extensive experience in clinical research and vaccines that includes both site and Institutional Review Board (IRB) development.
In her previous role as Senior Clinical Research Manager at FHI 360, Coyle was responsible for development of new proposals and for strategy development, communication and proposal building with team members both inside and outside of the organization. She provided clinical project management for the implementation of research projects, including initial project management of an Ebola vaccine trial in Sierra Leone, and she trained staff in clinical research fundamentals in Monrovia, Liberia. She also led the FHI 360 Clinical Research team in Vietnam for six years.
Coyle holds a bachelor’s degree in Nursing and a master’s degree of Education and Science in Public Health from the University of Toledo.
Twanna Davis is responsible for setting the overall direction, strategy and performance standards for international clinical research activities, including planning, executing, monitoring and reporting on international clinical trials. Davis leads and mentors FHI Clinical’s diverse international clinical monitoring team while maintaining the appropriate resources to meet contractual obligations and ensure adherence to quality management practices. She provides oversight to ensure that the organization and the conduct of regulatory and non-regulatory clinical programs comply with policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) guidelines in support of global business objectives.
Davis brings a total of 18 years of clinical research experience and a commitment to changing the world through innovation to her role at FHI Clinical. For the past seven years, she has been an adjunct faculty member at Campbell University’s College of Pharmacy and Health. She previously served as Principal Process Owner-Project Services at Rho, where she wrote companywide processes to assist with Trial Master File compliance standards across functional areas. Prior to joining Rho, she served as Senior Director of Clinical Operations, Global Clinical Monitoring Services at Premier Research, where she provided operational and strategic oversight for several countries.
Davis holds a bachelor’s degree from the University of North Carolina at Wilmington, as well as a master’s degree in Project Management and an MBA from DeVry University.
As Director of Global Contracts & Procurement, Chris Mikaelian leads a global team responsible for the negotiation and execution of FHI Clinical’s customer and vendor contract portfolio. Chris is a seasoned professional with over 15 years of contracts & procurement experience in the public health, pharmaceuticals and aerospace sectors. With extensive experience in both government and commercial contracting, Chris leads his team as it supports the pursuit of the organization’s strategic goals.
Previously, Chris served as the Senior Manager of Contracts & Procurement at DLH Corporation, where he was responsible for managing sponsor and vendor contracts in support of a >$100 million line of business supporting both government and commercial clients. Prior to that, Chris was Senior Manager of Contracts at Seqirus, Inc. (formerly Novartis), supporting the organization’s relationship with the Biomedical Advanced Research and Development Authority (BARDA) in support of the U.S. Government’s efforts to ensure pandemic preparedness for a future influenza pandemic. During his time at Seqirus, Chris worked closely with Global Project Management, Manufacturing, Regulatory and Clinical teams to ensure Seqirus’ facilities were ready to meet emerging infectious disease (influenza) threats. Prior to his time at Seqirus, Chris worked in Contracts & Procurement at Draper Laboratory and BAE Systems on platforms and systems critical to national defense.
Chris holds a bachelor’s degree in Business Administration from Bryant University in Smithfield, RI and a Master of Business Administration (MBA) in Corporate Finance from Boston College in Chestnut Hill, MA. Chris is a 2007 graduate of BAE Systems’ Finance Leadership Development Program and a 2013 graduate of the National Contract Management Association’s (NCMA) Contract Management Leadership Development Program (CMLDP). Chris lives in Fuquay-Varina with his wife and four children.
As Director of Human Resources, Leslie Heavey leads the global HR department for FHI Clinical, joining the Company as its launch in April 2019. As a Human Resources Generalist with more than 23 years of experience, Ms. Heavey brings experience in all functional areas of human resources including talent management, employee relations, leadership development, compensation and benefits, employment laws and policy compliance, organizational restructuring, M&As and training facilitation.
Prior to joining FHI Clinical, Ms.Heavey served as the HR business partner for the headquarters of Syneos Health, formerly INC Research. During this time, INC Research grew from 700 employees to more than 7,000 global employees and became a public company. Additionally, she managed the company transition throughout five M&A transactions resulting in the transition to Syneos Health with over 22,000 employees. Her prior human resources positions were with First Citizens Bank and Keane, Inc.
Leslie holds both the PHR and SHRM-CP professional HR certifications.
Director, Information Technology
With more than 17 years of experience in the clinical research industry, Gary Cook brings extensive experience deploying and operating IT infrastructure and applications in highly regulated environments, including clinical systems (21CFR11/validated systems), healthcare (HIPAA) and federal government (FISMA/NIST).
In his current position at FHI Clinical, Gary leads the IT department and serves as Information Security Officer and Data Protection Officer.
Before joining FHI Clinical, Gary served as Director of IT at Asklepios Biopharmaceutical, Inc (AskBio), a gene therapy biotech. He designed and built infrastructure and systems to support the fast-growing biotech, while supporting facility expansion.
During his 15-year tenure as Senior Director of IT at Health Decisions, a CRO focused on women’s health, Gary planned and directed company-wide initiatives, such as operational excellence, strategic direction and Federal Information Security Management Act (FISMA) compliance. He also initiated and led the establishment of the company’s IT service desk, which developed training, processes and procedures to support 120 employees and 500 external customers.