Clinical Research Director

1 maand geleden

Utrecht, Utrecht, Nederland Genmab Voltijd
About the Role

This is a key position in the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. The successful candidate will work closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.

Responsibilities
  • Lead or co-lead complex clinical trials in a therapeutic area for one or more compounds
  • Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
  • Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers to support registration and commercialization of the compound(s)
  • Contribute to the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables
  • Lead the development of medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
  • Provide medical input for country/site selection, feasibility assessment, and engage in KOL interaction
  • Prepare charters and coordinate internal/external committee meetings, including presentation preparation
  • Participate in the development and review of study plans and serve as a liaison to project teams and CROs
  • Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
  • Provide input for the development of publications in coordination with Scientific Communications
  • Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted
Requirements
  • PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
  • Minimum of 8 years of experience in clinical research with at least 4 or more years of drug development experience
  • Prior oncology/hematology drug development experience is a plus
  • Proven skills from working in a project-oriented matrixed team environment
  • Excellent oral, written, and interpersonal (communication) skills
  • Ability to travel, as needed
About Genmab

Genmab is a dynamic company that leverages the effectiveness of an agile working environment for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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