Subject Matter Expert Biographies - Meet our Team

Meet our Subject Matter Experts, here to answer your questions!
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Vince Calderon
Director Project Management

Vince serves as a Director and supervisor of Project Management, overseeing PSI’s team of Project Management staff and several studies in oncology and hematology. Vince has been with PSI since December 2019, and is based in Texas. He has over 19 years’ clinical research experience, 15 years of project management experience, and has delivered 20+ oncology studies in both solid tumors and hematology-oncology.

Vince has professional affiliations with the Project Management Institute in the US and has been a certified Project Management Professional since 2012.

Rhonda Critchlow
Head of Therapeutic Strategy

Rhonda Critchlow, Head of Therapeutic Strategy, currently oversees all of PSI’s core indications, and specializes in operational strategy within oncology and radiopharmaceuticals. With over 25 years of research experience, she provides valuable leadership and management working both regionally and globally.

Overseeing the therapeutic strategy department, which includes our Site Support Specialist, Rhonda brings guidance and oversight to specialty vendor management, patient recruitment and retention for our sponsors.

Prior to working at PSI, her experience includes working within oncology research as a Coordinator and Director, CRA, Clinical Trial Manager, Head of Monitoring and Vice President of Early Phase Oncology before joining PSI. Rhonda also has experience working with general radiology and nuclear medicine in large hospital organizations, providing valuable input for clinical development, study management and operational considerations.

Cecilia Dignani Director, Medical Monitoring and Consulting

Cecilia is a renowned & leading expert in antifungal studies. Cecilia holds an MD from the University of Buenos Aires, Argentina. She specialized in Internal Medicine and Infectious Diseases (both in Argentina). She further specialized in infectious diseases in cancer and transplant patients as a Clinical Fellow at the University of Texas, MD Anderson Cancer Center in Houston, Texas, and as a Research Associate at the University of Arkansas for Medical Sciences at the Myeloma Institute in Little Rock, Arkansas.

Cecilia has more than 18 years of industry experience as a consultant, an investigator, and a research associate. She is a member of The Argentinean Society of Infectious Diseases (SADI), the American Society for Microbiology (ASM), the Infectious Diseases Society of America (IDSA), and the Mycoses Study Group (MSG).

Her excellent relationships with KOLs and sites through her experience of challenging antifungal studies and global programs will ensure investigators stay motivated.

Nick Geiger Site Technology Specialist

Nick Geiger, Site Technology Specialist, is providing essential analytics for radiopharmaceutical trials which may require clinical dosimetry assessments. Nick is a board-certified medical dosimetrist (CMD). He holds a Bachelor’s degree in Physics, coupled with dual Master’s degrees in Medical Physics and the other in Medical Dosimetry. As a dosimetrist, Nick has been responsible for collaborating with Radiation Oncologists to develop patient-specific radiotherapy treatment plans in the clinical setting and has assisted in the departmental commissioning, implementation, and educational development of the latest applications and calculation models designed to simulate the absorbed radiation dose to cancer patients. At PSI, Nick uses his clinical background in physics and dosimetry to ensure that the safety of the patient remains the highest priority by closely analyzing and discussing trial objectives with all members of the study team, developing corporate-wide dosimetry-related training material(s), and staying up to date with the latest radiopharmaceutical regulations, technologies, and analytics. PSI’s Site Technology Specialist in dosimetry provides another robust layer of efficiency and expertise when conducting radiopharmaceutical trials thus enhancing our core objective of ensuring all trials run on time.

Alex Gilfanov
Head Project Management, North America

Dr. Alex Gilfanov, M.D., Head of Project Management in North America, has worked in the clinical research industry since 2006, including fourteen years with PSI. Specializing in gastrointestinal (GI) trials for the last eight years, he is responsible for supervising multiple large Crohn’s disease and ulcerative colitis programs.

As a project director, Alex provides general study supervision for investigators, sponsors, vendors, and functional departments at PSI, focusing on critical processes.

During his career, Alex has served in different roles across the clinical trial process, including treating physician, sub-investigator, and monitor, before managing and supervising clinical trials for the last 10+ years. This breadth of experience allows him to better understand the needs of patients and caregivers as well as all other stakeholders involved in clinical trials. A frequent guest at Digestive Disease Week, European Crohn’s and Colitis Organization Congress, United European Gastroenterology Week, and other large GI congresses, Alex is passionate about exploring all the current developments in gastroenterology to better understand the latest treatment options available to patients as well as the challenges they face along the way.

Tracy Heiges
Program Manager, Project Management

Tracy has worked in clinical research across a variety of settings and therapeutic areas, managing projects in GI, hematology, and oncology with PSI over the last 6 years. As a Program Manager, Tracy is process and quality focused, with a proactive approach to leadership, providing supervision to her project teams and collaborators for successful timely outcomes. She sees the big picture along with all the minute details needed to get there with a resilient and innovative mindset towards best practices and solutions.

Tracy is passionate about continual learning, growth and helping others win, especially the patients out there awaiting cures or better treatment options in the interim.

Sergii Karas
Program Manager, Project Management

Sergii is a Medical Doctor by training with over 17 years’ experience in clinical research and 40+ studies under his belt.

He is one of PSI’s infectious disease expert and has worked on 25 infectious disease studies including several global Phase III studies. Throughout his career at PSI, he held roles of increasing responsibility and is currently working as a Program Manager in Infectious Disease.

Lucy Knight
Director, Project Management

Lucy serves as a Director and supervisor of Project Management, overseeing PSI’s team of Project Management staff and several studies in oncology and radiopharmaceuticals. Lucy has been with PSI since October 2018, and is based in Manchester, UK. Lucy has over 19 years’ clinical research experience, 15 years of global, full-service project management experience, and has delivered 20+ studies in different oncology indications and radiopharmaceuticals.

In 2021 and in recognition of her project management skills, Lucy received a silver award from the PharmaTimes’.

Maxim Kosov,                                                            Senior Medical Advisor, Operations

Maxim Kosov, MD, PhD, is a Senior Medical Advisor, has worked in the clinical research industry for the past 20 years. He holds an MD from Pediatric Medical Academy of Saint-Petersburg, Russia, and before joining PSI, he worked as an intensive care physician in neonatal intensive care units of several major hospitals, and is the author/co-author of more than 50 publications, presenting research at conferences and events globally including ASCO, DIA and ERS.

Since joining PSI in 2004, Maxim’s role includes serving as a Medical Monitor in more than 60 clinical trials in various indications, managing various Data Monitoring Committees (DSMB, SRC, IRC), and serving as a PSI internal expert and head of the DMC Support Group. In addition, he has developed training programs for CRAs with a focus on Inflammatory Bowel Disease, radiology response evaluation criteria (RECIST, iRECIST, Lugano criteria etc.), and various oncology indications, that have been widely adopted at PSI and successfully used.

Emily Mcinturf with pink circle border

Emily McInturf
Director, Feasibility

Emily McInturf, Director Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives.

As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Colleen Ring
Associate Director, Feasibility

Colleen Ring, PhD, Associate Director, Feasibility, has worked in the clinical research industry for the past 12 years. Prior to transitioning to the clinical research field, Colleen was a senior research scientist, specializing in multiple signaling pathways (e.g. TGFb, Tyrosine Kinases, Rho/Rac GTPases) across a broad range of areas, including oncology. As a leader within PSI’s global feasibility team, Colleen specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecasting that models and compares hundreds of country and site combinations, their budgets and probability of success, Colleen develops recommendations for optimized enrollment in line with each sponsor’s key objectives.

As an Associate Director, Colleen provides leadership for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Wes Ross
Site Support Specialist

Wes Ross, Site Support Specialist, is one of PSI’s keys to addressing the complexities that lie in the conduction of radiopharmaceutical trials. Wes has a BS in Radiologic Sciences and an AS in Radiology and is also a licensed nuclear medicine technologist with over 22 years of hands-on experience working in the field. He has worked as a nuclear medicine technologist, working on the development and oversight of nuclear medicine research, and has worked in the creation of testing and controls for digital PET/CT technology. Wes uses his breadth of experience to drive PSI ahead of the curve for conducting successful research in the industry, developing new and exciting ways to get radiopharmaceutical studies up and running.

Wes manages the site qualification process for imaging studies and manufacturing radiopharmaceutical products, oversees the process of image acquisition and quality control, and is responsible for training trial sites, project teams, and vendors to deliver meaningful research in the requirements and strategies for the programs he works on. Wes works closely with other core units both within PSI and sponsor companies, such as project management, clinical operations, CMC, and supply chain to help design studies, project plans, and training materials in the radiopharmaceutical space.

Dylan Stoy
Director, Therapeutic Strategy

Dylan Stoy, PSI’s Therapeutic Strategy Director, is dedicated to conducting and executing better clinical studies in PSI’s core therapeutic areas. Dylan has worked in radiopharmaceutical research for about 9 years, with research interests in targeted drug delivery systems and optimizing the conduct of studies. Dylan has overseen radiopharmaceutical research from various roles including onsite research, design and trial conduct, clinical operations oversight, project management, and therapeutic strategy.

Dylan and his team are devoted to making participation for sites and patients in complex radiopharmaceutical studies more attainable and ensuring that PSI teams are highly trained and equipped to handle any challenges your program might encounter. Dylan works closely with the core business units within PSI, overseeing research throughout the study lifecycle, providing strategic leadership to our teams and collaborators (both internally and externally), and delivering corporate-wide trainings to make PSI your full-service CRO for all things radiopharmaceutical development.

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Heather Thompson Clinical Trial Liason

Heather Thompson, Clinical Trial Liason, is focused on helping PSI to meet the growing demand for technical and operational expertise in gastroenterology in clinical research. A board-certified nurse practitioner with more than 15 years of gastroenterology experience (focused heavily on Crohn’s disease and ulcerative colitis), she has provided a wide range of patient-centered gastroenterology care in outpatient, emergency department, and inpatient settings and primarily managed a large population of inflammatory bowel disease patients (most of which were on biologic therapy), including routine office visits, medication selection, tracking laboratory testing, and procedure follow-up to track patient progress and disease progression/remission. She also has five years of experience conducting training, discussing disease processes, and providing education on clinical trials for the medical community. She served as the regional nurse practitioner speaker in the pharmaceutical industry from 2017 to 2022, focusing on biologic therapy. Heather assists Project Management with study design and the creation of manuals, training materials, and study forms, as well as presenting at Investigator Meetings. Throughout the study, she is responsible for developing technical project tools, including site and project team training tools; identifying and tracking critical project issues; and assisting assigned CRAs with technical issues. Heather utilizes her clinical knowledge in working with multiple departments across the study lifecycle and is a critical resource for scientific and operational expertise to our Business Development, Project Management, and Clinical Operations Departments.

Kristin Williams
Director Project Management

Kristin Williams, Director of Project Management, oversees PSI’s team of Project
Management staff and several studies across oncology, radiopharmaceuticals, IBD, and rare disease. She is a seasoned professional with 28 years of industry
experience working at both large pharma and CROs. Kristin has been with PSI since 2012 and has managed and supervised some of PSI’s most complex projects. In
her previous roles, she has supported delivery of several drugs to market. She
is focused on maximizing operational excellence and delivery within the
organization.