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Clinical Trials Medical Expert

3 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are seeking an exceptional Senior Clinical Research Scientist to join our Solid Tumor Team at Genmab. As a key member of our team, you will play a critical role in the implementation of our global development strategy and lead or co-lead clinical trials in a therapeutic area for one or more compounds in early clinical development.

About the Job

This position offers a unique opportunity to work in a fast-paced and dynamic environment with a talented team of scientists and clinicians. You will have the chance to develop and implement cutting-edge research projects, collaborate with international partners, and make meaningful contributions to the field of oncology.

Responsibilities
  • Develop and implement research strategies for assigned trials/compounds and participate in the development of clinical development plans.
  • Collaborate with the Medical Director and other Clinical Research Scientists as needed.
  • 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.