About Integrium » Our Team
As experts with a reputation for excellence, Integrium has been able to attract and retain the best and the brightest in the clinical research and development field. Together with
our founders, they bring valuable insight to every project, helping clients successfully navigate the complexities of each unique clinical trial.
Executive Team
David H. G. Smith, MD
Founding Partner, Chief Medical Officer
Eileen McAuley, RN, MPA
Chief Operating Officer
Carmen Margaritescu, MD
Medical Director
Mary Spellman, MD
Head of Dermatology Clinical Research
Scott Rosenberger
Executive Director, Project Management and Clinical Excellence
Greg Dodds, MS
Vice President, Business Development
Liza Moore
Director, Field Operations
Stephen Duprez, MS
Director, Data Management
Mark McBride, PhD
Senior Director, Biostatistics & Statistical Programming
Shelda Maier
Associate Director,Quality Systems
Adam Steadman
General Manager, Cardiovascular Core Laboratory
Jessica Coutu
Senior Director, Contract Administration
Ewa Olesiak-Deptuch, MS
Senior Director, Finance
Regina Ottaviano
Director, Human Resources
Founding Partner, Chief Medical Officer
David H. G. Smith, MD is one of the founding partners of Integrium and serves as the Chief Medical Officer. In this role, he oversees the Medical Safety department, which provides pharmacovigilance and medical monitoring services. He also works closely with clients on program planning, protocol development and other key clinical matters. Dr. Smith brings substantial experience in clinical research and management to the operational capabilities of Integrium. His leadership has provided the visionary growth and ethical service bias essential in contract services outsourcing.
"Our existence and continued growth has always been in response to client need," according to Dr. Smith. "From the very beginning, our clients, both in the clinical development and marketing sectors of industry, came to us first for advice, and then for focused and efficient effort in the execution of well designed study programs. I am proud of the way Integrium has refined the critical relationship of scientific quality, regulatory muster and marketing relevance —understanding that all are essential to product advancement."
Dr. Smith completed his training in internal medicine and cardiovascular disease at the Veterans Affairs Medical Center, Long Beach, California and at the University of California, Irvine.
Dr. Smith has participated actively in research in the fields of hypertension, hyperlipidemia, diabetes, ischemic heart disorders and exercise stress testing. He has special interests in the study of the renin-angiotensin system, disorders of arterial compliance and endothelial dysfunction, 24-hour ambulatory blood pressure monitoring and the general pharmacotherapy of cardiovascular disorders. In addition to acting as Chief Medical Officer on a number of large international, multicenter clinical trials, he has authored numerous journal articles, abstracts, and book chapters and has formally presented at many scientific meetings. Dr. Smith is a member of several specialty organizations and has been designated as a Specialist in Clinical Hypertension.
Along with his leadership role, Dr. Smith has served many clients in the area of scientific and regulatory consultation and has further assisted sponsors with representation and participation in meetings held with the US Food and Drug Administration, as well as international regulatory authorities.
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Chief Operating Officer
As Chief Operating Officer, Eileen is responsible for driving and managing all aspects of operations. She provides leadership to the organization to ensure corporate objectives are achieved while client deliverables are satisfied. In her role, she is responsible for Project Management, Monitoring Services, Contract Administration, Data Management, Biostatistics & Statistical Programming, Human Resources, Information Technology and Quality Systems Department..
Eileen has worked for more than 20 years in the clinical research arena. Her experience ranges from Clinical Research Associate, Director of Project Management, Senior Director of Clinical Operations and Vice President of Clinical Operations. She has a proven track record for satisfying clients, managing individuals and delivering complex projects on time and within budget..
Eileen received her BS Degree from Montclair State College in New Jersey and began her career as a registered nurse working in critical care. She has a Masters Degree in Public Administration from Seton Hall University, with a focus on Health Policy and Management..
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Medical Director
Dr. Margaritescu serves as the Medical Director of the Medical Affairs department. In this role, she oversees a team of research professionals to provide pharmacovigilance, coding, IND reporting, laboratory surveillance and medical monitoring services, while working closely with clients and the Integrium project team colleagues to meet stringent reporting timelines.
Dr. Margaritescu provides over 25 years of clinical research and practice experience and nearly seven years of experience with Integrium.
Dr. Margaritescu completed her training at the University of Medicine and Pharmacy, in Bucharest, Romania. She held the positions of General Practitioner, Senior Specialist in Neurology, and Associate Director in Romania and worked in Clinical Research in the Department of Neurology at the University of Southern California
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Head of Dermatology Clinical Research
Dr. Spellman leads Integrium’s dermatology clinical research group. She is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has been instrumental in achieving US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines. She has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.
Dr. Spellman was previously employed as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications, and as Senior Director of Medical Research, Immunology at Biogen Idec, Inc, where she was responsible for global development of therapies for immunological indications that included psoriasis, asthma, Crohn’s disease, allergic rhinitis, and idiopathic thrombocytopenic purpura. Prior to joining Biogen Idec, Dr. Spellman was the Vice President of Clinical Research, Dermatology at Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company), where she headed development programs for therapies to treat psoriasis, acne, atopic dermatitis,and seborrheic dermatitis. She also worked as a Regional Scientific Director for Novartis Pharmaceuticals.
Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. Dr. Spellman earned her medical degree from the Medical College of Wisconsin. She completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. Dr. Spellman is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.
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Executive Director, Project Management and Clinical Excellence
Scott Rosenberger is responsible for leading Integrium’s Project Management Team and provides strategic guidance and oversight in the management and execution of clinical programs. In addition, Mr. Rosenberger is responsible for business process development, improvement and implementation.
He has over 20 years of Global CRO and Pharmaceutical operational experience in phase I-IV trials from protocol development through NDA submission. Mr. Rosenberger has diverse therapeutic experience including cardiology, allergy, asthma, immunology, gastroenterology and diabetes. Over the last 9 years Mr. Rosenberger has worked extensively in dermatology across numerous indications with topical, oral and injectible therapies. Prior to joining Integrium, Mr. Rosenberger held senior management positions with Clinsys Clinical Research, Target Research Associates and clinical scientist responsibilities at Wyeth Pharmaceutical.
He earned a Bachelor of Science degree in Medical Technology from University of Delaware and is a member of DIA and ACRP. He holds CCRA credentials through ACRP (certified clinical research associate) and is certified through the American Society of Clinical Pathologists as a registered Medical Technologist.
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Vice President, Business Development
Greg Dodds is responsible for leading Integrium’s business development initiatives.
He has over 20 years of experience with companies providing clinical research, market informatics, and strategic sales support services to the global biopharmaceutical and medical device industries. Prior to joining Integrium, Mr. Dodds held senior business development and marketing positions with Clinsys Clinical Research, Parexel International, Avia Health, and SMG Marketing Group (now part of Quintiles Transnational).
He earned a Bachelor of Science degree in economics from St. Vincent College and Master of Science degree in managerial economics and decision science from Northwestern University’s Kellogg School of Management.
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Director, Field Operations
Liza Moore has direct responsibility for the training and oversight of all Clinical Research Associates (CRAs) at Integrium Cardiovascular Research LLC. She is responsible for ensuring that all Integrium programs are monitored according to ICH/GCP guidelines and ensuring that all study timelines and deliverables are met ensuring the overall success of all Integrium programs. She has proven leadership skills in mentoring and overseeing a large department of Clinical Research Associates.
Liza has many years of Project Management experience conducting global, large and small scale clinical research studies. Liza has managed clinical research programs in a wide range of therapeutic indications including cardiovascular, hypertension, stroke, diastolic and systolic heart failure, diabetes, anti- infectives, wound healing, burns and rare skin disorders. Liza has worked in both the biotech and pharmaceutical industries and has experience conducting Phase I- IV clinical research programs. Prior to entering the field of clinical research, Liza worked at New York University Medical Center in a cardiac step down unit.
Liza holds a BSN from Dominican College in New York and a BA from Tulane University in New Orleans.
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Director, Data Management
Stephen Duprez is responsible for the conduct of all data management and programming functions at Integrium.
Mr. Duprez has over 33 years experience in the pharmaceutical industry. He worked for both pharmaceutical (Ayerst [now Wyeth], Revlon Healthcare Group and Rorer, Rhone-Poulenc Rorer [now Sanofi-Aventis]) and clinical research organizations (ICON, SCIREX [now Premier Research], Covance and Advanced Research Corporation) prior to joining Integrium. Starting his career in 1978, Mr. Duprez has been involved with or managed the data management or clinical operations of over 300 trials ranging from six-patient Phase I trials to over 10,000-patient global Phase IV endpoint trials. The therapeutic areas of these trials included Cardiovascular, Endocrine/Metabolic, Dermatology, Oncology, Central Nervous System, Ophthalmology, Anti-Infective, Allergy, Respiratory, and Gastroenterology.
Mr. Duprez also is an instructor for both the Data Management and Clinical Research Foundations courses for a Clinical Development/Clinical Research certification program in New Jersey.
Mr. Duprez holds a MS in Biology with a Minor in Business Administration from Seton Hall University. He received his BS degree in Biology from Norwich University.
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Senior Director, Biostatistics & Statistical Programming
Mark McBride oversees the biostatistics and statistical programming team and works closely with clients and project teams to provide statistical support for studies. He also provides statistical consulting for protocol development, study design and regulatory support.
Mark has more than 20 years experience in leadership and management of biostatistics and data management services to the pharmaceutical and biotechnology industry with a focus on combining strong technical knowledge with customer focused results. Mark consistently focuses on the customer and helps provide statistical services with the most positive customer experience in mind. His background includes managing data management and statistical activities for clinical trials in multiple therapeutic categories. He previously served in a variety of senior management positions in a leading global CRO, including Senior Vice President, Global Biostatistics and Data Management.
Mark received his PhD in Biostatistics from the University of North Carolina and a Bachelor of Science and Master of Science in Statistics from Brigham Young University.
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Assocate Director, Quality Systems
Shelda Maier is responsible for coordinating, participating in and managing sponsor and internal audits, as well as for the conduct of clinical site and vendor audits, ensuring that Integrium processes and systems meet all aspects of Good Clinical Practice, ICH Guidelines and FDA regulations. Other responsibilities include serving as the primary point of contact for regulatory authority inspections, maintenance of Integrium’s Standard Operating Procedure system and providing trend analysis to Senior Management regarding SOP compliance and audit risk analysis.
Ms. Maier has more than 14 years experience in the pharmaceutical industry, from regulatory compliance and validation services (META Solutions), to biotech (Genta), to contract research (Clinsys Clinical Research [formerly Target Research Associates] and Integrium). Her clinical research experience includes Oncology, Ophthalmology, Transplant, Allergy/Immunology, Cardiology, CNS, Dermatology, and Pulmonary.
Ms. Maier was a Fulbright grant recipient and earned a cum laude degree in German Language and Literature from the University of Montana.
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General Manager, Cardiovascular Core Laboratory
Adam has full management responsibility for the Integrium Cardiovascular Core Laboratory located in Tustin, CA. Additionally, Adam is responsible for the marketing of Integriums services, and has particular responsibility for development of the Device & Diagnostics division.
Before joining Integrium, Adam served as General Manager, VP Sales & Marketing, CFO and CEO of several organizations.
He has qualified as a Chartered Accountant, and holds a Bachelor of Accounting Science degree and a post-graduate Bachelor of Accounting Science degree (with Honors) from the University of South Africa in Pretoria.
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Senior Director, Contract Administration
Jessica Coutu is responsible for the preparation, review and negotiation of contracts with sponsors, investigative sites, consultants and vendors. She is also responsible for the preparation of responses to sponsor requests for proposals and the financial account management of all awarded studies.
Jessica has more than 20 years of experience with proposal preparation and review, contract negotiation, budget development, monitoring and management. Prior to joining Integrium, Jessica was the Director of Contracts and Proposals for two other leading CROs. Before that experience, she was the Associate Director of Grants and Contracts for the Saint Barnabas Health Care System and previous to that was also a position as the Director of Research Development for the Children’s Hospital of New Jersey at Newark Beth Israel Medical Center. In these positions, she managed all clinical trial and basic research activities and was a member of the Institutional Review Board. She has extensive clinical and basic research experience from both private industry and academic institutions, and has additionally presented and published her research.
Jessica earned her B.A. in Biology from the University of Rhode Island at Kingston.
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Senior Director, Finance
Ewa Olesiak-Deptuch is responsible for all financial functions for Integrium, including reporting, analysis, forecasting, revenue and expenditure accounting. She developed and implemented new company financial tracking systems.
Ewa has more than 12 years of experience in the CRO/pharmaceutical industry. Prior to joining Integrium, she was the Director of Finance for another CRO, Target Research Associates. She also has years of diverse accounting experience in a large multinational company with several subsidiaries and offices throughout the Americas. She managed the coordination and integration of consolidated financial statements, monitored and controlled capital authorizations and expenditures, and analyzed business trends and ratios. She has years of experience coordinating with external auditors for year-end audits, due diligence audits, tax audits, and Sarbanes–Oxley compliance audits.
She earned her M.S. in Mathematics from the University of Krakow, Poland
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Director, Human Resources
In her role as Integrium’s Director of Human Resources, Regina is responsible for positioning Integrium as an employer of choice in the clinical research industry. She directs all recruiting efforts, designs and administers competitive compensation and benefits programs. Regina leads the development and implementation of HR-related policies, processes and programs and serves as the liaison between staff and management for company-wide HR communications.
Regina has a successful background in human resource management in the biopharmaceutical industry – encompassing over 12 years of experience. Her expertise lies in the creation and re-engineering of Human Resources departments. She has extensive multi-state knowledge of policies, practices and processes, compensation structures, recruiting, employee relations including legal compliance, organizational structure and building competitive programs.
Regina holds a Bachelors of Science degree in Sociology from St. Bonaventure University and a Certification in Human Resources Management from Bentley College.
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