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.
Senior Vice President, Global Client Solutions
Claudia Christian has over 25 years’ experience in the execution of global clinical programs. Christian has held multiple positions from fieldwork to executive leadership in biotech, pharma and both large and niche CROs across all phases and multiple indications. She has broad experience managing industry-, government- and grant-funded portfolios.
Christian has successfully participated in executive ownership programs through mergers & acquisitions (M&A) and has a passion for corporate growth targeting challenging international markets with a focus on accessible and sustainable improvements in resource-constrained settings.
Prior to joining FHI Clinical, she served as Vice President, Global Operations for a niche CRO where she 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%.
She serves as Senior Vice President of Client Solutions, maximizing performance of a global expanding portfolio of programs and staff across Africa, the Americas and Asia in pandemic and infectious diseases.
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.
Abraham Van Wyk brings more than 15 years of clinical research industry experience to his role as FHI Clinical’s Managing Director of EU and Africa. Abraham previously served as the CEO of Triclinium Clinical Development (TCD) Global, where he executed the company’s acquisition by FHI Clinical.
While managing the TCD Group of companies, van Wyk led the M&A strategy, which included the acquisition of HeXor (now Value in Research), a health economics and outcomes research company, as well as being the co-founder of an eClinical solutions company (now NuvoteQ) and establishing TCD Global as a full-service CRO specializing in infectious disease and vaccine research across sub-Saharan Africa. The TCD Group of companies was sold to EOH (JSE Listed Group).
Abraham previously held the position of Managing Director of Africa at Cytespace Research (acquired by Premier Research). Prior to that position, Abraham established the East African region for Quintiles (now IQVIA) and managed the East and West African operations as Regional Head.
Abraham serves on the board of several biotech, medical device and medtech companies, including AMR-focused Bugworks; Burl Concepts, a medical device company; and NuvoteQ, an eClinical solutions company, among others.
Abraham holds a bachelor’s degree in medical sciences and a bachelor’s (Hons) degree in cellular biology from the University of Pretoria, in addition to an MBA from the University of South Africa.
Senior Director, Finance
Alan Hampton has 20 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.
Joy Carson brings more than 30 years of clinical research industry experience to her role as FHI Global Head of Clinical Science. Carson draws on her experience from academia, industry and contract research organizations to support the clinical development of small and large molecules, diagnostics and gene therapies from pre-clinical stages through product launch. She has designed and led studies from early phase and clinical pharmacology through registration and post-marketing in North America, Europe, Latin America, Asia and Africa.
Prior to joining FHI Clinical, Carson served as VP of Clinical Development and VP of Medical Communications at Asklepios Biopharmaceutical, where, in addition to contributing to the clinical development strategy for gene therapy candidates in rare diseases, she established a patient advocacy program to integrate the patient voice into the clinical development process.
Through her career, Carson held multiple positions of increasing responsibility in project management and clinical strategy. She designed and ran the first drug lottery programs for HIV protease inhibitors. Carson led the clinical development of what would become one of the first liquid biopsy assays for cancer detection. She advised global emerging biopharma clients on the development of their oncology assets, with specific experience assisting Asia-Pacific clients to transition their early-phase drug candidates through INDs in North America and Europe. She engaged with regulatory agencies across all phases of drug development and supported global regulatory submissions from IND through market launch.
Carson’s involvement in protocol design across therapeutic indications and phases of development allows her to bring insights into the evolution of study design and methods that support the most direct path to market for new products. Her recruitment and coordination of Clinical and Scientific Advisory Boards has introduced her to global key opinion leaders across clinical indications. Her leadership roles through the years included media relations and government outreach, including the recruitment of a US President and members of the US Congress and Senate in support of a patient advocacy fundraiser. Carson’s passion is coordinating clinicians, regulators, government, industry and patient advocates to advance global health initiatives.
Carson holds a BA in neuropsychology from Boston University and an MBA from the D’Amore-McKim School of Business High Technology Program at Northeastern University.
As Global Head of Clinical Affairs, Herbst is responsible for leading a dispersed team in regional offices and specific countries to deliver quality services and functions in alignment with corporate strategy, policies, procedures and applicable regulations.
Herbst brings 22 years of clinical research experience to the team. He previously held the position of Chief Operating Officer at Triclinium Clinical Development (TCD) prior to its acquisition by FHI Clinical.
His career started in data management at a global CRO and expanded into research and development and various other positions within several multi-international pharmaceutical companies. His therapeutic experience includes cardiovascular, dermatology, gastroenterology, immunology, infectious diseases, oncology, otolaryngology, respiratory, rheumatology, urology and vaccinology.
Herbst holds a bachelor’s degree in biochemistry and physiology as well as bachelor’s (Hons) degree in pharmacology clinical and analytical research from the University of Free State, South Africa.
Deputy Director, Clinical Operations,
Melvin has a diploma in nursing from the Tubman National Institute of Medical Arts (TNIMA) in Liberia, a Bachelor of Science degree in Nursing from Mother Patern College of Health Sciences in Liberia, and master’s degree in Healthcare Policy and Management from Cuttington University Graduate School of Professional Studies in Liberia.
Marié van Wyk brings 25 years of professional experience, including more than 12 years of clinical research industry experience to her role as FHI Clinical SA’s Global Head of Regulatory Affairs. She is responsible for global delivery of regulatory functions in alignment with the corporate strategy, policies, procedures and applicable regulations while maintaining the highest ethical, regulatory and scientific standards.
Her experience in regulatory affairs therapeutic areas includes an extensive range of indications and applications. The list of critical areas includes, but is not limited, to infectious diseases (including tuberculosis and HIV), oncology and vaccine trials (including COVID-19). Marié’s experience typically involves managing a clinical trial project from start-up to project completion. Her responsibilities include people management, trial management, budget management and customer interaction.
This regulatory affairs experience followed her extensive experience in various pharmacy environments as a retail pharmacist and hospital pharmacist in South Africa and the United Kingdom.
Marié not only holds a bachelor’s degree in Pharmacy from the North West University, South Africa but furthered her studies in the United Kingdom, where she obtained her MRPharmS (OSP) from Sunderland University. She also holds a management qualification from the Institute of Leadership & Management in the United Kingdom.
As Global Head 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 Global Head of Global Strategy, Joy Toro manages administrative operations of the country offices and oversees the study feasibility function, driving 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 more than 15 years of experience in business and clinical operations, Toro brings experience in project management, team facilitation, field monitoring and training for international project work in resource-limited settings.
Prior to joining FHI Clinical, Toro served as the Associate Director of Business Operations at IQVIA Biotech, where she was responsible for a large systems migration and process improvement. She was also 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 leadership 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.
Global Head, 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.
Craig McNees has over 10 years of experience in the clinical research industry. Craig’s experience ranges from project management to business development and strategic account management. Most recently, Craig managed and provided oversight to key, strategic accounts at a mid-sized CRO. Before that, he was a business development director at a larger CRO and was accountable for bringing in new business while overseeing current clients and growing and maintaining the client relationship. Craig is very passionate about creating a trusting and growth-promoting relationship with clients and team members.
Craig holds a bachelor’s degree in psychology from Pennsylvania State University. He lives in Cary, NC, with his wife and two children.
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.
Director, Clinical Operations (Africa)
Marlie Smit brings more than 20 years of experience in clinical research to her role as Director, Clinical Operations, under the FHI Clinical SA umbrella. Starting as a clinical assistant at a large multinational CRO in 2000, she has since held roles as a clinical research associate (CRA), Senior CRA, clinical team lead, project manager, and clinical operations manager as well as the Associate Director of Clinical Operations and Associate Director of Regulatory and Start-up. She joined a private development partner in 2014 as Associate Director and was promoted to Director Clinical Operations in 2017. She subsequently joined TCD in 2018 as a Senior Project Manager, following which she was promoted to Head of Project Management and the Associate Director of Operations before moving to her current role in February 2022. Marlie’s therapeutic area experience includes cardiology, vascular (devices), dermatology, gynecology, HIV prevention, musculoskeletal, oncology, psychiatry, psychology and urology (devices).
Marlie holds a bachelor’s degree in Dietetics from the University of Pretoria.
Spanning the spectrum of roles from study coordination to site and clinical team management to quality assurance, Felicia Ricks brings more than 20 years’ experience in clinical research to her role as Director, Quality Management Systems & Standards. Ms. Ricks is responsible for the overall management of quality at FHI Clinical, including development, support and maintenance of the quality management system. She and her team focus on risk identification and mitigation by promoting a culture of collaboration and proactive quality improvement. Her therapeutic areas of focus include chronic and end-stage kidney disease, type 2 diabetes mellitus, cardiovascular disease, anemia of chronic disease and mineral dysmetabolism, in addition to infectious diseases.
Ricks is a Certified Clinical Research Professional and holds a bachelor’s degree in Nutrition and Dietetics from the University of Texas Health Science Center at Houston. She is also a Six Sigma Green Belt.
Linda Duursema has more than 30 years’ experience in various roles and positions in the clinical research setting, of which, more than 14 years have been in a quality assurance position.
Linda has formal clinical research audit training, including certificates in Good Clinical Practice (GCP) Auditing, Auditing Computerized Systems, and Systems Audits (British Association of Research Quality Assurance [BARQA]). She has completed a number of GCP training courses as well as various courses related to clinical research and has expert knowledge of ICH GCP; South African GCP and local legal requirements; and European, FDA and other relevant international guidelines applicable to clinical research. She is a committed, meticulous person with uncompromising attention to detail, the ability to think analytically, efficient problem-solving abilities and good interpersonal skills. She also encourages a collaborative team spirit. Linda has proficient knowledge in a wide range of therapeutic areas and is able to communicate effectively in English, both orally and in writing.
A registered pharmacist with the South African Pharmacy Council, her academic qualifications include a BPharm (cum laude), BMedSc (Hons), MMedSc (cum laude) and PhD in Pharmacology.