2 associate director biostatistics jobs found

Detailed Description of Duties: Otsuka is seeking an Associate Director/Director/Senior Director, Global Clinical Development based in our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS and Digital Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director/Director/Senior Director, Global Clinical Development include the following: Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols. Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing,...

Position Summary The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives. The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings. Key Job Responsibilities Conceives, implements, and analyzes drug development programs, including: Understanding pharmacology of drugs and unmet medical needs. Formulating a...