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Senior Research Scientist Clinical Lead
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At Genmab, we strive to revolutionize cancer treatment by developing innovative antibody products and pioneering therapies. Our team is dedicated to creating a workplace where everyone can thrive and contribute to our mission of transforming patients' lives.
The Role & DepartmentThis position plays a crucial role in the implementation of our global development strategy, leading or co-leading clinical trials in a therapeutic area for one or more compounds in early clinical development. The successful candidate will work closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.
Key Responsibilities- Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds.
- Collaborate with the Medical Director and other Clinical Research Scientists as needed.
- Contribute to the development of program strategies for assigned trials/compounds and participate in the development of clinical development plans.
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs.
- Provide medical input for country/site selection, feasibility assessment, and engage in key opinion leader interaction.
- Assist in training investigators, sites, and CRO/CRA as warranted.
- Contribute to the development of clinical and regulatory documents and registration dossiers, including protocol, ICF, IB, annual safety updates, study reports, and regulatory submissions (briefing documents, IND, clinical dossiers).
- Participate in the development of case report forms and their completion guidelines and provide scientific support for other key data management deliverables.
- Prepare charters, presentations, and coordinate/participate in relevant committee meetings, such as Dose Escalation, Data Monitoring, and Safety Committees.
- Lead the development of the medical data review plan, perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis.
- Provide input for the development of abstracts/publications in coordination with Scientific Communications.
