The team at Target Health LLC is comprised of over 70 talented individuals with decades of experience in the pharmaceutical industry, both in the US and worldwide.
Dr. Jules T. Mitchel is CEO of Target Health LLC, a New York City based CRO with expertise in Regulatory Affairs, including FDA interactions and all submissions, Strategic Planning, Clinical Research Management, Biostatistics and Data Management, Medical Writing, Good Manufacturing Practices (GMP) and other support services to the pharmaceutical industry. Dr. Mitchel has broad base pharmaceutical experience in drugs, biologics, devices and diagnostics including three NDA submission, many FDA meetings and IND/IDE submissions, study reports, manuscripts and strategic planning. Areas of expertise include but are not limited to, Women's Health, Dermatology, Antimicrobials, Pharmacokinetics, Rheumatology, Ophthalmology, Natural Products, Oral Care, Oncology and Regulatory Affairs. Dr. Mitchel has held industry positions at American Home Products, Pfizer Laboratories and Pfizer Consumer Health Care and academic positions at New York Medical College, Cornell University School of Medicine and NYU School of Medicine.
Vice President of Operation and Administration
Joyce is the Vice President of Operation and Administration of Target Health LLC and brings over 25 years of experience in the areas of marketing, finance and corporate strategic planning with extensive background in psychology, design and communication. Co-founder and CFO of MarSat Development Corporation (Consumer Products) and CFO of Dobex International (Gas and Oil Research). Ms. Hays also founded the Institute for Interdisciplinary Communication, a scientific think tank funded by the National Science Foundation. Ms. Hays earned B.S. and M.S. degrees from Columbia University in New York City. Founder of Target Health LLC and Target Health Global LLC.
Yong Joong Kim joined the Data Management team at Target Health in 1999. He designed and developed the EDC system shortly after joining the company and has been part of the continued growth of the company. He oversees the Data Management operations and involves in development and enhancement of the clinical trials software and strategic directions for the company. Yong Joong holds a Master’s Degree in Computer Science and held a position at the Rockefeller University as a System Analyst/SAS Programmer for 10 years worked on NIH funded clinical trials before joining Target Health.
Senior Director, Software Development & IT
Joonhyuk Choi is the Sr. Director, Software Development & IT at Target Health. With over 15 years of experience specializing in clinical trial software solution and technology-driven processes, he is responsible for creating software platform and strategic enhancement of products and operations. Prior to Target Health, Joonhyuk worked as an ERP System developer at Samsung Electronic Service.
Joonhyuk graduated with a B.S. in Electrical Engineering from Rutgers University. In his spare time, he and his family enjoy alpine skiing and snowboarding, bowling, tennis and golfing.
Senior Director of Regulatory Affairs
Mary Shatzoff is a Regulatory Affairs Executive and has been working in the pharmaceutical industry in clinical drug development for the past 20 years. She has been a Senior Director of Regulatory Affairs at Target Health LLC since 2006. Before she joined Target Health she worked as a Manager of Regulatory Affairs at Sanofi Aventis and a Quality Control Microbiologist at Pfizer. She is an active member of The Regulatory Affairs Professional Society (RAPS) as well as the Drug Information Association (DIA). Two of her articles have been published in Applied Clinical Trials Magazine and RAPS Focus Magazine. She received a Bachelor of Science in Biology from Northeastern University, a Master of Science in Regulatory Affairs from Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, and is currently working on a Master of Science degree in Molecular Biology from Lehigh University. Mary lives in New York City. Certificates: Regulatory Affairs Certification (RAC-US), Certified Quality Auditor (CQA)
Director of Clinical Research
Clinical research was a natural evolution for me after over 15 years as an RN/NP in trauma, cardiology and infectious disease with a specialty in HIV/AIDS. As Director of Clinical Research at Target Health, I have the privilege of working with a diverse and multi-talented team of Project Managers, Clinical Research Associates and Clinical Operations Specialists who collectively bring to the table over 100 years of expertise in clinical trial management, clinical monitoring, expedited study start-up, patient recruitment and study feasibility assessment. This team also specializes in innovation. They are pioneers in ground-breaking technology using Direct Data Entry to conduct paperless clinical trials to actualizing risk-based monitoring strategies.
Director of Biostatistics
Director of Business Operations
Director of Business Operations assures optimization and communication within Target Health LLC Neil has been with the company since 2008 and is the primary contact for all business matters at Target Health LLC. He works directly with the CEO and President and is responsible for office and facilities services, including planning and logistics for all company events and Investigator Meetings. Neil received a Bachelor of Arts in Industrial/Organizational Psychology, as well as a Master of Science in Marketing & Public Relations from NYU. He has many years of client relationship and vendor management experience. Neil is also fluent in Spanish.
Associate Director of Regulatory Affairs
Adam Harris, MM, RAC, currently leads drug, device, and combination programs at Target Health LLC, a full service Manhattan-based CRO. Adam started his career in brand drugs at Sanofi-Aventis in post approval drug regulatory affairs and CMC, and then moved to generic drug regulatory affairs at IVAX Pharmaceuticals, which was later bought by TEVA Pharmaceuticals. Next, at Siemens Healthcare in-vitro diagnostics, Adam began his involvement in the medical device regulatory world. In 2010, he brought his device expertise to Target Health and works closely with sponsors to interact with FDA to obtain critical feedback in a multifaceted regulatory sphere. Adam also manages regulatory staff at Target to meet a demanding and diverse submission schedule on behalf of clients.
Adam has authored regulatory strategies for numerous drug, device, and combination programs while at Target, shepherding a number of investigational programs throughout the dynamic and highly interactive pre-submission process. Adam has achieved more than 10 FDA approvals in devices alone, and has lead more than 17 in-person FDA meetings. In addition to holding both a Bachelor's and a Master's degree, Adam maintains the Regulatory Affairs Certification (RAC) from RAPS and is currently working on a Master of Science in Jurisprudence degree at Seton Hall University.