We Provide Scientific Excellence Around the World
Our experience is broad, but our expertise runs deep. While our services are amplified by TEMPO™, our technology eClinical platform, our people are at its core. One of the most important steps in building a successful partnership is getting to know your team—their scientific and operational expertise, areas of strength, and individual qualities they bring to your project. Below is just a sampling of our experts. Click on a photo below to learn more about each team member.
- Peter Langecker, MD, PhDExecutive Medical Director, Global OncologyUnited StatesPeter Langecker, MD, PhDExecutive Medical Director, Global Oncology
Peter provides medical expertise within Clinipace and externally, acting as Chief Medical Officer or Medical Monitor for sponsor medical projects and provides clinical development strategy advice, feasibility assessments, and monitoring oversight for select clients. He has more than 25 years of experience in clinical oncology and oncology drug development, specializing in the planning and implementation of clinical Phase I-IV studies, regulatory strategy, and FDA and EMA interactions and submissions. Following his early career as Medical Monitor at Ciba-Geigy and Schering-Plough, he has served in senior roles in several pharmaceutical and biotechnology companies including Coutler, SUGEN, Intarcia, DURECT, and OXiGENE.
Peter received his MD and PhD in medical sciences from the Ludwig-Maximilians University.
- Ofelia Rodriquez Nievas, MDSr. Director, Project Operations; Medical Affairs DirectorArgentinaOfelia Rodriquez Nievas, MDSr. Director, Project Operations; Medical Affairs Director
With almost 30 years of experience as a Medical Oncologist, Ofelia has been on both sides of the clinical research counter – as an investigator while she was still practicing, and then on the clinical operations and medical affairs side after joining the CRO industry over a decade ago.
Her main areas of expertise include oncology and conducting clinical trials in Latin America.
Ofelia says: “At Clinipace, we go to work every day with the goal of pursuing new therapies through collaboration in order to bring better treatment options to those who need them.”
- Barbara Geiger, BSN, RNEVP, Global OncologyUnited StatesBarbara Geiger, BSN, RNEVP, Global Oncology
Barb has more than 25 years of experience in the conduct and management of Phase I-IV clinical trials and in the evaluation and selection of global clinical trial vendors. Prior to founding Worldwide Clinical Research (WWCR) in 2000, she spent 10 years at global CROs.
Additionally, Barb spent eight years at a major pharmaceutical company and started her clinical research career in a Phase I/II private research unit. She's an executive clinical operations professional with extensive experience in oncology and CNS drug development.
Barb says: “Therapeutic experience is not the only thing that matters when selecting a CRO or assigning a project team member. It is really operational knowledge and experience that make the difference.”
- Ingrid Lo, MSSr. Director, Project ManagementTaiwanIngrid Lo, MSSr. Director, Project Management
With more than 14 years of experience in clinical research at the Center of Drug Evaluation, GlaxoSmithKline, Quintiles, and Clinipace, Ingrid has acquired an in-depth knowledge of the drug development, clinical trial conduction, trial management, and regulatory perspectives. She also has experience in managing clinical operations across Phase I to Phase IV in various therapeutic areas, most extensively in vaccine development and oncology.
Ingrid is a licensed pharmacist by training with a bachelor’s degree in pharmacy and a master’s in pharmacology.
- Dirk SpruckGlobal Director, Statistical ProgrammingGermanyDirk SpruckGlobal Director, Statistical Programming
Dirk has worked in the pharmaceutical industry for 25 years and has extensive experience in data analysis programming, clinical data integration, electronic data submission, data standardization (i.e. CDISC SDTM & ADaM), complex SAS programming, and standard macro development.
He has been an active member of industry working groups like the PhUSE Computational Science working group helping to shape the future of Statistical Programming and Clinical Data Science.
- Cindy VenendaalVP, Clinical Operations, AmericasUnited StatesCindy VenendaalVP, Clinical Operations, Americas
Cindy has worked in clinical operations and drug/device development across pharmaceutical, biotechnology, and clinical research organizations for the past 17 years. Her experience includes executing global clinical trials throughout North America, Asia Pacific, Latin America, and Europe. Cindy has managed Phase I-IV clinical trials across a wide variety of therapeutic areas, focusing mainly on oncology studies. She has been heavily involved in vendor selection/management, protocol development, CSR review, and support for IND and NDA submissions/approvals.
Cindy earned her PhD in clinical science from the University of Colorado and Master of Public Health degree from the University of Northern Colorado.
- Martin CrippsVP, Clinical Operations, EuropeUnited KingdomMartin CrippsVP, Clinical Operations, Europe
Martin has worked in clinical operations and drug and device development in pharmaceutical, biotechnology, and clinical research organizations for the past 17 years. He has a thorough command of operational requirements in North America, Europe, Asia Pacific, and Africa, and has managed cross-functional and multi-cultural teams ensuring productivity and quality.
- Jeongsook Choi, MPHSr. Director, Project ManagementSouth KoreaJeongsook Choi, MPHSr. Director, Project Management
Jeongsook has worked in the clinical research industry for more than 25 years, dividing her time between a pharmaceutical company and clinical research organization. She has significant experience in the management of clinical research operations and global research and development and has previously worked at MSD and Novartis. Her experience is in clinical operations, covering various therapeutic areas including cardiovascular, endocrinology, psychiatry, respiratory, vaccine, and dermatology.
Jeongsook received her Master of Public Health from The School of Public Health at Seoul National University and also holds a Bachelor of Science in Pharmacy from Ewha Women’s University.
- Ron Marks, PhDGlobal Director, BiostatisticsUnited StatesRon Marks, PhDGlobal Director, Biostatistics
A biostatistician by training, Ron has spent his 40+ year career designing, conducting, and providing data analyses from all types of clinical research, from clinical trials to epidemiologic, observational, and registry studies. His research area of interest has been focused on clinical trial design. He has extensive experience in ophthalmic, cardiovascular, geriatric, and dental research areas. He also has research experience in numerous other therapeutic areas.
Ron received his MS and PhD in Statistics at the University of Florida and served on the faculty at the J. Hillis Miller Heather Center at the University of Florida for 30 years before co-founding and joining Clinipace Worldwide.
Ron says: “Our focus at Clinipace is to work with clients to understand the tremendous value in spending a little more time planning on the front end of study design and study setup which more than pays off during study conduct and on the back end of the study in producing quality data and final study results more quickly and with more confidence.”
- Walter Zhao, MSProject Management DirectorChinaWalter Zhao, MSProject Management Director
Walter has more than 10 years of combined experience working in clinical research at a hospital and at international pharmaceutical companies including Bayer and Novartis. He has led and completed numerous global and Chinese clinical research studies from Phase I to Phase IV in therapeutic areas such as cardiovascular, endocrinology, nephropathy, neurology, DVT, vaccine, rheumatism, non-cancer pain, and infectious disease.
Walter earned a master’s degree in cardiology from Hebei Medical University.
- Andrei Kravchenko, MD, PhDCorporate Director, Medical AffairsUkraineAndrei Kravchenko, MD, PhDCorporate Director, Medical Affairs
As the Corporate Director Medical Affairs, Andrei consolidates medical resources and services in the company. As Country Director, Ukraine, Andrei is responsible for managing all operational, financial and regulatory activities in Ukraine.
Andrei began his career in clinical operations more than 14 years ago. He has also served as a medical manager for the EMEA region with responsibilities for coordinating medical monitoring globally. His primary interests lie in medical services and operations, the consolidation of medical talents in R&D processes, local expertise, cost-effective management of clinical trials, tailoring solutions with a focus on feasibility, rescue projects and project management.
- Nikolas BurlewVP, Regulatory and Strategic DevelopmentUnited StatesNikolas BurlewVP, Regulatory and Strategic Development
Nik is a Regulatory and Strategic Development QA professional working under GMP and GLP regulations providing auditing, training, system development, and project management services, in addition to authoring CMC sections for US and EU applications.
Nik says: “The most important consideration a client should take when undertaking a clinical research project is that ALL drugs going into humans MUST follow good manufacturing practices. Engaging an experienced partner helps avoid not complying with GMP rules and regulations.”
- Mabel FengClinical Operations Director, Asia PacificSingaporeMabel FengClinical Operations Director, Asia Pacific
With close to 16 years in the conduction and management of local and regional clinical studies in Asia, Mabel has significant experience managing quality procedures and regional and local studies in metabolic, hepatology, cardiovascular, vaccine oncology, and gastroenterology. She has previous experience working at Singapore General Hospital, GlaxoSmithKline Singapore, Sanofi-Aventis Singapore, and the Singapore Clinical Research Institute.
Mabel has a degree in applied science and applied biology/biotechnology from RMIT University.
- Mark Shapiro, MA, MBAVice President, Clinical DevelopmentUnited StatesMark Shapiro, MA, MBAVice President, Clinical Development
A pharmacologist by training, Mark has almost 20 years of experience spanning virtually all aspects of drug development.
He completed an MBA at Duke University’s Fuqua School of Business. Prior to Duke, Mark did master’s and doctoral work in pharmacology and biomolecular pharmacology at the Boston University School of Medicine. He received a bachelor’s degree in chemistry at Virginia Tech.
- Peiling ShihRegulatory and Strategic Development DirectorTaiwanPeiling ShihRegulatory and Strategic Development Director
Peiling has worked in the pharmaceutical industry for 23 years and has extensive experience in early phase drug development, analytical quality control, drug/medical device registration activities like IND, NDA, ethnic sensitivity evaluation, line extensions, post-approval amendments, and registration maintenance.
She has 18 years of experience in the regulatory affairs of Taiwan, Korea, China, and the ASEAN Region from her time at General Electric Healthcare, Abbott, American Cynamid, and a US-based generic company.
- Marie HanleyVice President, Global Quality ServicesUnited StatesMarie HanleyVice President, Global Quality Services
Marie has worked in the clinical research industry for more than 30 years. Over the past 12 years, she has been in global regulatory and quality assurance roles. With a Bachelor of Science in Nursing and post-graduate work in biostatistics, she began her research career as a research nurse and study coordinator.
Marie is a champion of compliance and process improvement, with global regulatory inspection and audit expertise.
Marie says: "As Steven Covey once said, 'begin with the end in mind.' The end in mind for CPWW and our Sponsors is regulatory approval for a new therapy. Although we maintain a robust internal QA audit program, you can’t audit quality in, it must be a part of the fabric of an organization from the top down and the bottom up. At Clinipace, this perspective is a key to running successful, compliant studies that pass inspections. Having this perspective allows us to challenge the way things have been done, to look for opportunities to improve, and to build reproducible quality into everything we do. This is not a static or singular process, but requires a culture of continual process improvement, staff training, and maintaining a quality system that helps deliver on that objective. Having an awareness, that your ultimate ‘customer’ is the Regulatory Inspector inspecting the study data, the patients who participate, our sites and our Sponsors, keeps our focus on what is important in the conduct of clinical research.“
- Frank Wierckx, MS, PhDExecutive Director, Regulatory and Strategic DevelopmentSwitzerlandFrank Wierckx, MS, PhDExecutive Director, Regulatory and Strategic Development
Frank has almost 25 years of experience in all aspects of regulatory affairs (non-clinical, clinical and quality), working both in big and mid-size pharma. His experience covers global projects that developed from non-clinical until approval and post-marketing life-cycle management for small molecules and biologicals. His emphasis is on strategic regulatory aspects to optimize the outcome of drug development.
Prior to his work, Frank graduated as a PhD in toxicology from the Leiden Academic Center for Drug Research (Leiden University, the Netherlands). He obtained a master’s degree in pharmaceutical sciences from Leiden University.
- Beth Garrard, PharmDEVP, Global Safety OperationsUnited StatesBeth Garrard, PharmDEVP, Global Safety Operations
A pharmacist by training, Beth has more than 20 years of experience in pharmaceutical product safety based on monitoring adverse event data for use in medical practice for both clinical investigations and post marketing. Her experience includes extensive industry-based global pharmacovigilance with both CROs and sponsor based companies with a focus in clinical research, disease management, quality, regulatory, compliance, training, risk management, benefit risk analysis, aggregate data analysis, and signal detection and management.
Beth completed her doctorate in pharmacy at UNC’s School of Pharmacy in Chapel Hill, NC.
- Sandra Schefler, RPh, MBASr. Director, Project OperationsBrazilSandra Schefler, RPh, MBASr. Director, Project Operations
Sandra has worked in the clinical research and pharmaceutical industry for nearly 20 years and has significant experience conducting clinical trials in oncology, cardiology, and rheumatology. During this time, she has developed skills in quality control, leading the scientific information department on supporting internal and external clients and being a part of the global core team in clinical trial operations.
Sandra holds a bachelor’s degree in pharmacy and subsequent specialization in industrial pharmacy as well as an MBA from Faculdades Getúlio Vargas.
Sandra says: "Respect to regional and country specific culture in addition to a constant and fluid effort of supporting our local experts aligned with a global innovative workplace scenario at Clinipace are key factors to achieving excellence in our day-to-day deliverables within clinical operations and project management.”
- Scott Miller, PhDSenior BiostatisticianUnited StatesScott Miller, PhDSenior Biostatistician
Scott has nearly 15 years of experience in statistical design, registry design, and analysis of clinical trials ranging from Phase I to Phase IV. He also has 10 years of experience conducting basic science research in several molecular biology laboratories. Prior to coming to Clinipace, he spent five years as a statistical reviewer at the FDA’s Center for Devices and Radiological Health.
Scott received a bachelor’s degree in biology from the College of Charleston and a PhD in biostatistics from the Medical University of South Carolina.