Leaders in innovation

Jonathan has over 20 years of clinical trial experience in early clinical and late-stage studies holding roles within Clinical Operations and Project Management. He brings diverse therapeutic experience with primarily focus on CVMER trials that include advanced CV imaging (e.g. MRI, CCTA), CVOTs, renal / hepatic impairment, core lab management, and collaboration with academic and commercial sites around the globe. In his leadership role as Delivery Director, Jonathan provides oversight of project development and execution while serving as a senior point of contact for his clients. Jonathan has a Bachelor of Science degree in Biology and earned a MBA from Harding University. Jonathan is a Certified Project Manager (via Project Management Leadership Group) and has completed a Midlevel Leader Excellence Program (via Harvard Business Publishing).

Diane is a Board-Certified endocrinologist and Senior Medical Director supporting the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea. Dr. Gesty-Palmer completed her internal medicine training and endocrinology fellowship at Duke University. She has over 20 years of clinical and translational research experience in broad range of endocrine therapeutic indications including T1D, T2D, obesity, MASH, cardiovascular outcomes.

Maria Paula Ghirardi, MD, is Medical Director of Oncology for Fortrea Clinical Development Services, based in Buenos Aires, Argentina. Dr. Ghirardi has 6 years of Oncology clinical research experience in both pharmaceutical and CRO industry. She provides clinical and medical expertise to project team and other Fortrea departments to advance clients’ drug development programs and contributes to the scientific strategic leadership of the Oncology therapeutic area. She has experience leading important launches of hematology-oncology compounds for multiple myeloma, AL amyloidosis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. 

Dr. Ghirardi earned her medical degree from the University of Buenos Aires and completed her internal medicine residency at the Hospital Ramos Mejia in Buenos Aires and Hematology residency at the Hospital de Clinicas in Buenos Aires and Sociedad Argentina de Hematologia. She joined our company in October 2022.

• Senior Medical Director at Fortrea.  Board certified internist and nephrologist
• 15 years clinical experience as internist and renal physician including serving as in-house nephrologist at dialysis centers.
• Clinical trial industry related experience since 2009.   Collaborating with sponsors serving as project medical lead and scientific advisor on various therapeutic indications including CKD and End Stage Kidney Disease, Lupus Nephritis, hemodialysis study and associated complications

Walter Gonzalez is the Associate Director of Digital Health and Innovation Delivery, boasting over 13 years of pioneering experience in Clinical Trial systems across pharmaceutical, healthcare IT, and CRO industries. Walter's expertise spans Phase I through Phase IV trials, with a strong focus on strategic planning, business development, and program management. He is a leader in leveraging cutting-edge DHT platforms, including eCOA, consent, telehealth, EDC, and Wearables, to drive transformative innovation and efficiency in clinical trials.

Brian has over 20 years clinical research experience, having worked at biotech companies, a global CRO and GlobalCare Clinical Trials. Brian joined Fortrea in 2020. He has hands-on experience in clinical operations, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA/regulatory submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Neurology, Rare Disease, Oncology, Cardiovascular, Women’s Health and Trauma research and has spent the last 4 years dedicated to Ophthalmology.

Brian is passionate about patient centric clinical trials and finding creative solutions to reduce site and patient burden in a space filled with complex and debilitating disorders.

Brian is based in the US.

Dr. Gutiu is a board-certified neurologist with more than 15 years of clinical experience in a hospital setting across a wide range of neurological and psychiatric indications. He spent 10 years in academia as Assistant Professor of Neurology and attended doctoral courses in neuropharmacology. His 28 years of clinical research experience includes roles as an investigator, medical monitor and medical leadership positions spanning Phase I-IV studies.

He has broad range of experience across product modalities, including biologics and cell and gene therapies as well as medical expertise in neuro and psychiatric diseases, including, but not limited to, neurodegenerative, pain, neuromuscular and demyelinating.

Based in Germany.

Konstantin Haradinov, MD, is a Medical Director, Oncology for Fortrea, based in Sofia, Bulgaria. He contributes to the development of Fortrea policies involving medical, safety and therapeutics; serves as global lead project physician and provides medical and safety monitoring on assigned projects; reviews medical data and provides clinical and medical expertise to project teams and other Fortrea departments, and performs safety trend analyses. 

Dr. Haradinov has more than 15 years of experience in clinical research as a medical director and physician/oncologist. Before joining Fortrea he served as Medical Officer, Oncology, for Chiltern International in Sofia, Bulgaria. Dr. Haradinov joined our company in April 2019.

Dr. Hoelscher has 26 years of CRO industry experience in a wide variety of therapeutic areas, most recently in the past 16 years focusing on medical monitoring in ophthalmology indications including: Retinal: dry/wet AMD, Non-infectious Uveitis, DME, Macular edema in uveitis, Vitreomacular traction, Proliferative/non-proliferative diabetic retinopathy. Anterior indications: dry eye, Glaucoma/POAG. Gene therapy: wet AMD, Batten’s disease. Rare disease: Batten’s disease, choroideremia, Stargardt’s disease, Retinitis Pigmentosa, Leber’s amaurosis.

While in medical school, he participated in Parkland Hospital’s “Mavericks in Ophthalmology” program, leading to a long fascination with research and the clinical practice of vision care.

Dr. Hoelscher is based in Austin, Texas.

Krane Huang, MD, is a Senior Medical Director, China Regional Head of Oncology for Fortrea, based in Shanghai, China. Dr. Krane has nearly 20 years of experience as medical oncologist in cancer hospitals, global pharmaceutical industries and CROs, focused on planning and execution of global oncology clinical development projects in all phases (I-III), different drug types and classes. 

Dr. Krane earned his medical degree from Tongji Medical College, Huazhong University of Science & Technology and completed his internal medicine degree and medical oncology fellowship training at Wu Union Hospital. He joined our company in September 2019.

Kazuya Iwamoto, MD, PhD, MBA, FACP, is Senior Medical Director for Fortrea in Osaka, Japan. He provides medical and scientific expertise to oncology study teams on clients’ drug development projects and contributes to the development of medical strategies and execution of clinical trials. Dr. Iwamoto has more than 25 years of experience as a physician, research clinician and medical director. 

Before joining Fortrea, he was Head of the Medical Division, including Clinical Development and Medical Affairs, for Hospira Japan in Osaka. He previously served as Head of the Medical Division for Biogen Idec, Head of Medical Affairs for Bayer Yakuhin, and Clinical Research Physician for Eli Lilly in Japan. Currently President and Fellow of the Japanese Association of Pharmaceutical Medicine, Dr. Iwamoto joined our company in May 2016.

Publications

• Biomarkers in head and neck squamous cell carcinoma: unraveling the path to precision immunotherapy

James Joyce is a Delivery Director within the Biopharma group of Global Project Delivery, specializing in Phase Ib through Phase III studies in Obesity as well as Liver Disease including MASH/MASLD (metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease), Primary Sclerosing Cholangitis and Primary Biliary Cholangitis and Cirrhosis indications. James brings extensive core lab imaging experience, biopsy histology and pathology management, sponsor portfolio oversight and governance. He has worked for 25 years in the pharmaceutical industry, 15 years of which have been at Fortrea (formerly Labcorp and Covance) in Project Management and Director roles. He is based in Atlanta, Georgia, USA.

Dr. Kam is a trained OB/GYN with more than a decade of CRU early drug development experience across multiple indications. As a Certified Physician Investigator (CPI) and Medical Director at the Phase I Dallas CRU, Dr. Kam conducted over 200 trials in BE, DDI, FE, FIH, Japanese Bridging and TQT studies. In 2022, she joined the CPS Medical Scientific Team as a Phase I Medical Monitor and currently is one of the Senior Medical Director at Fortrea. Her expertise in Women’s Reproductive Health includes serving as PI on OC-DDI studies, consultation of endometriosis, lactation and post-menopausal studies. She was the lead author for Fortrea’ s birth control guidance, “Evidence-Based Guidance for Contraceptive Use in Phase I and Clinical Pharmacology Trials Including Women of Child-Bearing Potential” and presentation of the guidance at the 2015 Annual Meeting for ACCP poster session.

Louise Kearney is Head of Rare Disease, Pediatrics and Cell & Gene Therapy Strategy and Delivery at Fortrea. She has 25 years of experience across sites, biotech, pharmaceutical, and CRO companies. She has worked at Fortrea for 21 years, including 10 years in Project Management and 8 years as part of the Rare Disease, Advanced Therapies, and Pediatric team, where she established best practices for these complex studies. Her current role combines strategic leadership and delivery accountability for programs across the therapeutic areas within this portfolio at Fortrea. Louise acts as the central point of coordination for all CGT-related activities and workstreams.

Jinju Kim, MD, PhD, is a Medical Director of Oncology for Fortrea, based in Seoul, Korea. Dr. Kim has over 10 years of clinical development/clinical research experience in pharmaceutical industry and academia including a broad range of clinical drug development activities and cross functional collaboration. 

Dr. Kim earned her medical degree from Hanyang University and majored in Internal Medicine at Hanyang University Graduate School, Korea. In addition, she completed her internal medicine residency and fellowship training at Hanyang University Hospital and then worked as clinical physician and research professor. She has worked for various clinical and project-facing roles as a medical lead at both global pharmaceutical and innovative biotech companies since 2015. She joined our company in 2022.

Ryan Kirby has over two decades of industry experience, with more than 12 years at Fortrea. As a founding member of Fortrea’s Digital Health & Innovation group, he is recognized as a leader and subject matter expert within the Digital Health field. He has been instrumental in the organization’s advancement and adoption of digital solutions and works with industry partners to champion innovative strategies that enable Fortrea to deliver clinical trials. Ryan specializes in leveraging technology to create efficient digital strategies designed around optimized data workflows to enhance the trial experience for all stakeholders.

Michiel has over 21 years of drug development and clinical research experience in both pharma and CROs. He joined Fortrea in 2011 providing project management and delivery leadership oversight across many CVMER projects, from Phase I through Phase IV, including registrational and post-marketing programs. Michiel heads up the delivery team and overall accountable for the successful execution of the portfolio in cardiovascular, metabolic, endocrine and renal diseases. Michiel fosters relationships across the CVMER industry, including Fortrea’s sponsors and vendors, collaborating on their clinical development programs and understanding their key needs.

Marcin Koziej, MD, is a medical director of oncology for Fortrea based in Warsaw, Poland. Dr. Koziej has more than 33 years of experience in medical onco-pulmonary research centers, CROs and the pharmaceutical environment. His roles have included physician and investigator, clinical operations professional and project management leader of pan-European and global teams, medical monitor and advisor, clinical strategist, business advisor and mentor. 

Dr. Koziej earned his medical degree from the Warsaw Medical School, Warsaw, Poland and completed his internal medicine fellowship at the National Research Institute for Tb and Lung Disease in Warsaw, Poland. In 2016 he joined Chiltern, which then became part of Labcorp in 2020 and is now Fortrea.

Publications

• Neoadjuvant therapy in hormone Receptor-Positive/HER2-Negative breast cancer
• Intracellular DNA sensing by neutrophils and amplification of the innate immune response