Genmab
posted about 2 months ago
At Genmab, we're 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 Senior Clinical Research Scientist, you will play a crucial role in the Medical department, contributing to the implementation of the global development strategy. You will lead or co-lead one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. This role involves 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 position, 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. Your contributions will also extend to the development of case report forms (eCRFs) and providing scientific support for key data management deliverables. You will lead the development of the medical data review plan (MDRP), perform ongoing data reviews, and summarize efficacy and safety data for interpretation and analysis. Additionally, you will engage in country/site selection, feasibility assessments, and KOL interactions. You will prepare charters and coordinate internal/external committee meetings, including presentation preparation for various committees. Your role will also involve providing input for the development of publications in coordination with Scientific Communications and contributing to training at Investigator meetings and CRO/CRA training as warranted. This position reports to the Director of Clinical Research Scientist.