Unclassified - Roseburg, OR
posted 2 months ago
At Genmab, we are committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. As a Sr Clinical Research Scientist in the Medical department, you will play a crucial role in contributing to the implementation of the global development strategy. This includes leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds at various stages of clinical development. Your responsibilities will encompass clinical trial implementation and oversight of all aspects of clinical development, working closely with the Medical Director and other cross-functional teams to ensure high-quality and timely deliverables. In this role, you will be responsible for the development of the program strategy for assigned trials and compounds, participating in the creation of the clinical development plan (CDP). You will collaborate with the Medical Director to develop clinical and regulatory documents, including annual safety updates and registration dossiers. Additionally, you will participate in the development of case report forms (eCRFs) and provide scientific support for key data management deliverables. Your expertise will be essential in leading the development of the medical data review plan (MDRP), performing ongoing data reviews, and summarizing efficacy and safety data for interpretation and analysis. You will also contribute to country/site selection, feasibility assessments, and engage in interactions with key opinion leaders (KOLs). Your role will involve preparing charters and coordinating internal and external committee meetings, including presentation preparation for various committees. Furthermore, you will participate in the development and review of study plans and serve as a liaison to project teams and CROs, providing input for the development of publications in coordination with Scientific Communications. Training at Investigator meetings and CRO/CRA training will also be part of your responsibilities as warranted.