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Regulatory, operations and finance professionals join global clinical research organization.
January 24, 2017
By: Business Wire
SynteractHCR, a full-service, international contract research organization (CRO), has appointed four new senior-level managers to its international leadership team. Miguel Fuentes joins as executive director, Service Delivery; Patrick F. Loebs, MSW, MPH, as senior regulatory affairs manager; Katharina Grote, as finance director, and Ewelina Mazur-Janik, M.D., as medical monitor. The new executives draw on clinical research, operations, regulatory and finance experience from across the globe. Based in Spain, Fuentes, executive director for service delivery, will provide leadership for development and implementation of tools and processes to expedite study start up, enrollment, conduct and closure, as well as global, regional and country improvements initiatives. He will report to Martina Kroener, managing director and vice president of European Operations. Fuentes draws on 20 years of clinical, regulatory and therapeutic experience in the areas of oncology, cardiovascular, infectious diseases, neuroscience, respiratory and inflammation. He leverages extensive experience in clinical operations, global site selection and management and project management from past experiences working at drug developers and CROs. Most recently, he was a global head, site selection for an international clinical research organization. He has a master of business administration degree in pharmaceutical and parapharmaceutical from CESIF Madrid, and a master of science degree in pharmacy, sanitary specialist from Universidad Complutense. Loebs joins SynteractHCR as a senior regulatory affairs manager working remotely and reporting to Dr. Martine Dehlinger-Kremer, vice president of global medical and regulatory affairs. As a primary contact for regulatory clients at SynteractHCR, Loebs will represent regulatory affairs on internal and external project teams, manage regulatory projects and ensure compliance with regulatory guidelines. Loebs draws on 30 years of experience in regulatory affairs, project management, medical writing and clinical operations across pharma, CRO and academic research organizations. He received master’s degrees in public health and social work from the University of North Carolina at Chapel Hill, in maternal child health and health administration, respectively. Working from the Warsaw, Poland office, Mazur-Janik joins as SynteractHCR’s oncology medical monitor. Mazur-Janik is a board-certified oncologist with extensive practice and pharmaceutical industry experience. She will also be reporting to Dehlinger-Kremer. Mazur-Janik spent more than nine years in clinical oncology, during which she treated patients with cancerous solid tumors, served as an investigator for clinical trials and participated in numerous congresses. She has also worked in hospitals in Poland; Los Angeles, Calif. (Cedars-Sinai Medical Center); and Tel Aviv (Sheba Medical Center), and has laboratory research experience. Most recently she was a medical advisor at a global pharmaceutical company, responsible for medical affairs, supporting clinical development, safety, marketing, regulatory as well as patient relations. She graduated with a medical degree from the Medical University of Lodz, Poland. She is currently finalizing her Ph.D. in the history of medicine. Grote is SynteractHCR’s new European finance director, working from the Munich, Germany, office. In this role, Grote will report to Keith Kelson, chief financial officer, and be responsible for European accounting and finance functions, including overseeing the department and staff. Grote has more than 10 years in finance, tax consulting, accounting and auditing leadership experience at technology and professional services companies. She earned a degree in business administration, law and macroeconomics from the University of Bielefeld and holds qualified auditor and qualified tax advisor designations in Germany. “At SynteractHCR, we realize our people are critical to our mission of collaborating with clients to create a better future for patients. For this reason, we look to the best and brightest and empower them to drive innovation and provide integrity in all that they do. Our latest new hires continue our commitment to leading the industry, as we further expand and grow our international presence to help pharmaceutical and biotech companies worldwide,” said Wendel Barr, CEO. SynteractHCR is a full-service contract research organization with a two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and 60 countries, offering expertise across multiple therapeutic areas, with notable depth in oncology, immunotherapy, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
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