Assoc Dir Clin Research Scientist (DG)
Job Location: Princeton, NJ (see all jobs in NJ)
Work Type: Hybrid
Date Posted: 2022-04-26
Associate Director Clinical Research Scientist
Princeton, NJ (Hybrid) 2-3 days onsite preferred
The AD CRS contributes to the implementation of the global development strategy, leading one or more clinical trials in Oncology for one or more compounds in various stages of clinical development. This may include clinical trial implementation, and oversight of all aspects of clinical development working closely with the Medical Director and other cross functions to provide high-quality and timely deliverables.
Work towards the development of the program strategy for assigned trials & compounds to participate in the development of the clinical development plan. Work in collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers. These include safety updates, study reports, regulatory submissions to support registration and commercialization of the compound. Assist/participate in the development of case report forms , eCRFs completion guidelines, and provide scientific support for other key data management deliverables like database lock activities. Lead the development of the medical data review plan , perform ongoing data review, and summarize efficacy and safety data for interpretation and analysis. Provide medical input for country site selection, feasibility assessment and engage in KOL interaction. Prepare and coordinate internal & external committee meetings including presentation preparation. Participate in the development and review of study plans and serve as a liaison to project teams and CROs. Provide input for the development of publications in coordination with Scientific Communications. Prepare presentations for Investigator meetings, CRO/CRA training. May serve as a mentor to other Clinical Research Scientists.
PhD, PharmD, MS or equivalent degree preferably within the pharmaceutical science or related areas. Minimum of 5 years of experience in clinical research with at least 3 or more years of drug development experience. Prior Oncology experience is a must. Experience working in a project oriented matrixed team environment. Excellent oral, written and interpersonal (communication) skills. Ability to travel to as needed (1-2 times per year)
Please contact Darren Gutowski at email@example.com
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