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Oncology Drug Development Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Genmab is committed to fostering a workplace where everyone can thrive and contribute to our mission of transforming patients' lives. As a Senior Clinical Research Scientist on our Solid Tumor Team, you will be part of a talented team of scientists and clinicians working together to develop innovative antibody products and pioneering therapies.

About the Team

Our team is passionate about creating a workplace where everyone feels valued, respected, and empowered to contribute their best work. We believe that diversity, equity, and inclusion are essential to our continued success and are committed to fostering a workplace where everyone can thrive.

Responsibilities
  • 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.