Jersey City, New Jersey, United States
Seasoned pharmaceutical executive with vast experience in building and leading Clinical (Development and Operations) Groups. Extensive Clinical Development experience in a variety of indications including CNS, Women’s Health & Endocrinology, Pain and Anesthesia, CV, Inflammatory Diseases & Oncology. In depth knowledge of and experience with change management, mergers & acquisitions. Hands on experience developing sourcing strategies, SOP development & implementation, leading process enhancements, establishing compliance and performance metrics and implementing oversight principles. Citizen of the Netherlands, worked in Japan (2001) and since 2005 US resident.
Member of eDRC/EDST, Chair of the Global Study Management platform comprised of leadership from all Chugai Affiliates and HQ. Design and execution of all early clinical development studies conducted in the US across all therapeutic areas of Chugai Pharma. Line management of the Early Clinical Development Department at CPUSA.
Global Head Study Management, Early Clinical Development with line managerial responsibility for groups of Study Management personnel in Japan (Tokyo, Chugai HQ), the USA (Berkely Heights, CPUSA, NJ) and UK (London, CPE). Member of the Global TCRD Leadership Team and TCRD-DRC as well as the CPUSA Management Team. Study responsibilities across all Chugai therapeutic areas including Oncology (ALK, NTRK, GPC-3, EREG), Inflammation (Endometriosis, NMO), Pruritis (AD & Dialysis), Hypoparathyroidism, Paroxysmal Nocturnal Hemoglobinuria (PNH), Hemophilia A, Hyperuricemia (Gout).
Member of the supervisory board of Vestra Clinics in Prague, CZ. Vestra Clinics s.r.o. is a life science company, dedicated to conducting Randomized Clinical Trials in the CNS/Neurology area, located in Prague, Czech Republic. Vestra Clinics consists of a team of 15 skilled professionals with a background in medicine and biosciences. The group includes several MD Clinical raters/Clinical investigators, study nurses and clinical coordinators, an administrator and a recruitment specialist. Daily management is performed by the CEO (Dr. L Pazdera, MD) and overseen by the Board of Directors. http://www.myvestra.org/
Member of the Mesoblast Executive Team. Responsibilities include line management of Clinical Operations consisting of the Clinical Trial Management group, Data Management, Biostatistics & programming and Medical Writing. Responsible for Study Management, timeliness and budgets, Vendor Management, Data Analysis and Reporting. Responsibility for Clinical Studies in all therapeutic areas including GVHD, CV (MI, CHF), Inflammatory diseases (Crohn's & RA), Diabetes and Diabetic Nephropathy and Chronic Discogenic Lower Back Pain.
Budget and Line Management responsibility. Head of the trial optimization group consisting of a management team and over 20 professionals. Responsible for all planning, modeling/simulation forecasting of anticipated recruitment timeliness for in house performed phase II-III clinical studies across all therapeutic areas including all operational feasibility assessments , pro-active risk identification, EMR/EHR patient profiling and identification, heat mapping. Responsible for Recruitment & Retention planning and use of new technologies. Lead for the e-consent initiative. Voting panel member on behalf of the Clinical Development and Execution Organisation on the Scientific and Operational Review board reviewing and approving any new protocols to be executed by Merck Research Laboratories.
Budget and line management responsibility. Leading a management team and a total of over 60 people located in the USA (NJ and PA) and The Netherlands. Responsible for all clinical development activities and execution of every study in CNS (psychiatry and neurology), Opthalmology and Anesthesia indications. Responsible for timely trial and program execution within budget and quality standards. Leading integration of SPRI CNS into newly developed CNS group in MRL. Leader for the worldwide ‘regional integration team’, design scope, responsibilities and HQ interface for all local clinical operations in each of the countries where Merck/MSD has a presence.
Budget and Line Management responsibility. Leading a management team of 9 senior Clinical Project Managers and a total of over 65 people located in the USA (NJ) and The Netherlands. Responsible for all clinical development activities and execution of every study in both CNS and Anesthesia indications. Responsible for timely execution within budget and according to quality standards. Leading integration of Organon Clinical Development into SPRI.