The Novella Clinical team brings an average of 25 years of industry experience to our customers.
W. Richard Staub, III, President
Richard Staub is president of Novella Clinical and serves as a member of the Quintiles’ Clinical Development Leadership Team. Instrumental in establishing Novella Clinical as a premier provider of CRO and staffing services to the clinical research industry, Mr. Staub served as both president and CEO prior to Novella’s 2013 acquisition by Quintiles.
Before joining Novella in 2004, Mr. Staub was senior vice president of global business development at one of the world’s largest clinical research organizations. Mr. Staub’s career in the pharmaceutical industry began at Zeneca Pharmaceuticals in 1989 where he had progressive responsibilities as a medical and hospital sales representative, cardiovascular portfolio analyst and marketing manager.
In 2011 he was named the Ernst & Young Entrepreneur of the Year Carolinas winner, which celebrates entrepreneurs who transform economies, drive innovation and change communities.
Active in multiple civic and nonprofit groups, Mr. Staub currently serves as a board member for the Tammy Lynn Center for Developmental Disabilities.
Charles Lambert, Chief Financial Officer
Charles Lambert is chief financial officer for Novella Clinical and oversees all aspects of the company’s financial operations. As an integral part of the executive management team, he develops strategies to maintain Novella’s fiscal health and strong growth trajectory.
Prior to joining Novella Clinical, Mr. Lambert spent 12 years in the healthcare IT sector, serving as CFO for Misys Healthcare Systems and Capario. Throughout his career, he has held numerous executive-level positions within the healthcare, technology and industrial sectors across the US, Europe and Asia. Mr. Lambert graduated from Cambridge University in the United Kingdom and is a qualified Chartered Accountant.
Frank Santoro, MD, Chief Medical Officer
Dr. Frank Santoro is Novella Clinical’s chief medical officer and has more than 25 years’ clinical research experience. As a physician and clinical researcher, he offers valuable insights into protocol strategy and study design for Novella’s customers. Prior to joining Novella Clinical in 2008, Dr. Santoro served as vice president, clinical development and medical affairs for Protherics, a UK-based biopharmaceutical company specializing in oncology and critical care products.
Dr. Santoro has served as a project physician for more than 100 domestic and international studies, and directed project team activities for numerous multi-therapeutic Phase I-IV research programs. He has extensive experience managing global operations having directed global project management, clinical monitoring, pharmacovigilance, regulatory and biometric services.
Rob King, Chief Operating Officer
Prior to joining Novella Clinical in 2006, Mr. King held multiple executive-level positions within the clinical research industry. During that time he managed US and European operations as well as regulatory and quality assurance departments.
Mr. King sits on the Data & Technology Coordinating Center (DTCC) Clinical Research Advisory Board and has been an active member since 2003. He has also served as faculty and an advisory board member at several local universities. Mr. King holds a Bachelor of Arts from the University of North Carolina at Wilmington.
Nick Dyer, Chief Commercial Officer
Nick Dyer serves as chief commercial officer where he is responsible for growth and diversification strategies for Novella Clinical. He manages the global business development team as well as the proposals and contracts group.
Prior to joining Novella, Mr. Dyer was vice president, drug development partnerships at Quintiles where he was responsible for the sales, operations and financial performance of partnership activities.
A graduate of the British National Health Service (NHS) general management post graduate program, Mr. Dyer holds a Bachelor’s Degree in Economics from the University of Greenwich, London, and is a Chartered Public Finance Accountant.
Krystyna Kowalczyk, Executive Vice President, Global Operations (Project Management)
As executive vice president of global clinical operations at Novella Clinical, Krystyna Kowalczyk has more than 20 years’ experience in clinical research, augmented by 15 years in Phase I-IV trial management. She oversees all clinical projects, ensuring that aggressive project timelines are met and all deliverables exceed client expectations.
Ms. Kowalczyk has experience in both drug and device development and her therapeutic areas of expertise include oncology (solid and hematology), respiratory, CNS, women’s health, osteopetrosis and organ replacement. While a project leader of Phase I studies for a transdermal device program within a large pharma organization, she successfully brought three device/drug combinations into human trials. As part of larger teams, she has supported eight market approvals. Ms. Kowalczyk holds a Bachelor of Science in Biology from Davidson College.
Elizabeth Edwards, Executive Vice President, Global Operations (Clinical Monitoring)
Elizabeth Edwards is responsible for the global clinical monitoring division at Novella Clinical. With 20 years of industry experience, Ms. Edwards brings both a large pharmaceutical and biotech background and has worked extensively in North America, Europe, Israel, and Asia Pacific. She is a trained medical writer and program leader for multiple successful NDAs and sNDAs. From 2011-2014, she held the position of managing director of Novella’s European headquarters in Stevenage, England.
Ms. Edwards’ diverse therapeutic expertise spans oncology, pulmonary, ophthalmology, musculoskeletal, inflammatory, gastroenterology and urology. She is a graduate of the University of Virginia with a Bachelor of Arts in Psychology and Pre-Medicine.
Rob Stallings, Executive Vice President, Novella Clinical Resourcing
Rob Stallings leads Novella Clinical Resourcing (NCR), which delivers customized staffing and functional outsourcing services to the pharmaceutical, medical device and biotechnology industries in North America and Europe. With more than 20 years of healthcare and pharmaceutical resourcing and outsourcing experience, Mr. Stallings provides both strategic guidance and day-to-day operational leadership for NCR’s global staff.
Prior to joining NCR, Mr. Stallings served as executive vice president at a major US-based clinical staffing firm with responsibility for the company’s overall operations. He also worked for a leading health care recruiting firm as a physician recruiter and held various leadership roles in operations, business development and communications.
Jamie Gault, Global Head of Regulatory Affairs
Jamie Gault is responsible for leading Novella Clinical’s global regulatory affairs department. With more than 25 years’ experience, she has a broad regulatory background and strong knowledge of the technical aspects of new drug approval. Ms. Gault has implemented global regulatory programs, provided strategic regulatory advice to customers, and acted as a liaison with regulatory authorities, including both the FDA and Health Canada, on behalf of sponsors across multiple therapeutic areas. She began her career as a bench chemist and has progressed through CMC, regulatory compliance and regulatory affairs positions at pharma, biotech and service organizations.
Ms. Gault received a Bachelor of Science in Chemistry from Fairmont State College and has held a Regulatory Affairs Certified Credential from the Regulatory Affairs Professional Association (RAPS) since 1996.
David Novotny, Vice President, Medical Device & Diagnostic Division
David Novotny is vice president for Novella Clinical’s Medical Device & Diagnostics Division and has more than 15 years of clinical research experience in hospital, CRO and sponsor environments. He is responsible for the oversight and operational success of all medical device and diagnostic sponsor programs, including clinical execution and governance management. Prior to joining Novella in 2007, Mr. Novotny served as the US head of operations for a global vascular device company in Chelsea, England.
Mr. Novotny’s therapeutic areas of experience include cardiovascular, vascular, gastroenterology, endocrinology, urology, CNS, orthopedic, neurology, wound care and dermatology. He is a graduate of the University of Iowa with a Bachelor of Science in Exercise Science and an emphasis on physiology and business management.
Deborah Turunjian, Vice President, Oncology Division
Deborah Turunjian is vice president for Novella Clinical’s Oncology Division and has more than 30 years of leadership experience in business operations managing global outsourcing and strategic partnerships in more than 25 countries. Specifically, she has 10 years of operational management experience of Phase I-III global oncology clinical trials in both sponsor and CRO organizations.
Prior to joining Novella in 2010, Ms. Turunjian served as director of clinical operations for OSI Pharmaceuticals. Based out of Boulder, CO, she also holds an executive leadership role overseeing Novella’s western US operations. She has a Bachelor of Science in Nursing and is certified as a Clinical Research Contract Professional (CRCP).
European and Asian Operations
Chris Smyth, Ph.D., MBA, Managing Director, European & Asian Operations
Based in Novella’s European headquarters in Stevenage, England, Dr. Chris Smyth oversees clinical research and operations in Europe and Asia. He also supports oncology delivery operations in all markets outside the US.
Dr. Smyth has more than 20 years’ research and development experience in the pharmaceutical industry. He has led clinical research organizations and biopharmaceutical companies in both Europe and the US, dealing exclusively in hematology and oncology drug development since 2003.
Dr. Smyth earned his Ph.D. in Reproductive Biology from the University of Edinburgh and an M.B.A. from Henley Management College, United Kingdom.