Jonathan B. Kamien, Ph.D. Califon, NJ 07830 Profile • Analytical and well-rounded professional with over 20 years of combined medical education and academic experience in communicating clinical and scientific information. Extensive experience includes: Developing and guiding strategies and tactics for nonbranded market shaping initiatives for pre-approval products, branded programs for disseminating scientific findings and knowledge about disease states and medications, and activities supporting the launch of newly approved products. These strategies and tactics have included, but are not limited to, content development for speaker training, advisory boards, slide kits and enduring materials, including meeting abstracts, posters and podium presentations Shepherding projects through the medical and legal review process, including presenting and defending materials before publication review committees Notable skills in successful recruiting and interfacing with medical thought leaders Comprehensive management experience and excellent supervisory capabilities Being a strategic partner to clients as the medical lead in conceptualizing scientific stories for novel chemical entities early in their developmental process. Regular participation in conceiving responses to RFPs and delivering pitches for new business opportunities, both as the medical lead and as part of the onsite pitch team Diverse experience in multiple therapeutic areas Strong understanding of GPP, PHRMA Code of Conduct, FDA regulations, OIG, and related guidelines Medical and scientific direction, writing, editing, proofreading and publishing, including managing and developing medical writers and editors Exceptional proficiency in computers, computer programming, database design and data management. Seeking new challenges in promotional medical education and publishing Education Bachelor of Arts (B.A.–Biology and Psychology Joint Major–Departmental Honors) 1978-1982 Middlebury College Doctor of Philosophy (Ph.D. - Biopsychology) 1982-1987 The University of Chicago Work Experience Senior Medical Director 2008 to present Oglivy CommonHealth Medical Education, Ogilvy CommonHealth Worldwide Responsible for accuracy and integrity of scientific content of activities, including development and review of manuscripts, posters, abstracts, slides, etc. Identify new educational opportunities, participate in pitches (RFP responses, pitch material development and as part of on-site pitch teams), recommend and communicate with clients (marketing and medical affairs), KOLs and program faculty. Develop promotional activities that include publication development and scientific articles, meeting symposia and other educational activities, retrospective data collection and analysis, scientific advisory boards and consultant meetings. Supervise medical writers and editors. Diverse Medical Education experience spanning multiple therapeutic areas including CNS (addiction, pain, epilepsy, ADHD), infectious diseases, CKD anemia, dermatology, bariatric surgery, cystic fibrosis, and acne. Scientific Director 2007 to 2008 SynerMed Communications, Califon, NJ Duties and Responsibilities similar to above. Developed CME activities that included publication development, meeting symposia and other educational activities, learning objectives and needs assessments for CME grants. Responsible for peer-reviewed publication development and submission. President 1996 to 2008 Biopsych Consulting Califon, NJ Software Development of custom-designed software for conducting clinical trials and human laboratory studies of pharmacological and behavioral therapies for drug dependence. Founded sole-proprietorship to fill the need for software for conducting my own and others‟ research studies. Programming skills (LabVIEW „G‟, Visual BASIC, FileMaker Pro database design, websites & applications). Customized software products include applications for data acquisition, data analysis and electronic case report forms (eCRFs). Client list and product descriptions are available at http://biopsych.com. Senior Scientist 2000 to 2006 Friends Research Institute, Inc., Los Angeles, CA Co-Investigator and Project Director for randomized clinical trials (Phase II/III) of behavioral therapies for drug dependence sponsored by the National Institute on Drug Abuse. Protocol development: Designed, wrote and implemented research protocols. Supervisor for all research personnel, including training personnel in Good Clinical Practice, authoring Standard Operating Procedures, ensuring adherence to protocols and quality assurance (12 direct reports). Medical and scientific literature: Critical evaluation and summarization. Preparation, publication and presentation of research findings. Publication list available on request. Data analysis specification and supervision. Data Acquisition Software: Designed and authored custom-made software for collecting data and conducting studies. Regulatory affairs: Responsible for all communication with regulatory and sponsoring entities. Negotiated contracts with clinics and vendors. Responsible for >$500K annual research budget. Co-Investigator and Research Associate 1998-2000 University of Colorado Health Sciences Center, Denver, CO Duties and responsibilities similar to above. Scientist II 1994-1996 Addiction Research Foundation, Toronto, Ontario, Canada Principal Investigator for research evaluating possible antagonists of alcohol‟s subjective effects in human volunteers (Sponsor: Province of Ontario). Established human behavioral pharmacology laboratory and responsible for all aspects of research program. Created Addiction Research Foundation/Macintosh Excel for Operant Work (ARF/MEOW) software. Other duties and responsibilities similar to above. Research Fellow 1991-1994 University of Vermont College of Medicine, Burlington, VT Directed the Human Drug Discrimination Laboratory. Established new human drug discrimination technique (“Novel Response Procedure”). Other duties and responsibilities similar to above. Research Associate and Instructor in Psychiatry 1989-1991 McLean Hospital/Harvard Medical School, Belmont, MA Directed Non-human Primate Research Laboratory (rhesus monkeys). Supervised all aspects of research and research personnel (5 direct reports). Managed major renovation of laboratory, including design and vendor specifications, and supervision of contractors. Regulatory correspondence: responsible for Institutional Animal Care and Use Committee interactions Member of IACUC. Other duties and responsibilities similar to above. Post-doctoral Fellow 1987-1989 Harvard Medical School New England Regional Primate Research Center Preclinical research with squirrel monkeys (drug discrimination, drug self-administration, rate effects) Demonstrated promise of dopamine antagonists as target drugs for cocaine addiction. Discovered behavioral interactions of buprenorphine and cocaine. Clinical Research Experience Protocol Development for pharmacological and behavioral studies of drug dependence. Supervision of research personnel, including GCP, SOP adherence. Co-Investigator and Project Director for one of the initial Phase II evaluations of buprenorphine-naloxone for treating opioid dependence (Sponsor: NIH, NIDA Grant RO1 DA11160). Co-Investigator and Project Director for randomized clinical trials (Phase II/III) of behavioral therapies for drug dependence (Sponsor: NIH, NIDA Grant RO1 R01 DA13638). Principal Investigator for research evaluating possible antagonists of alcohol’s subjective effects in human volunteers (Sponsor: Province of Ontario, Addiction Research Foundation). Author of over 30 peer-reviewed publications.
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