Clinical Leadership Opportunity for Global Inspection Readiness

1 week ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are seeking a seasoned clinical leader to spearhead our global inspection readiness efforts, ensuring seamless compliance with Good Clinical Practice (GCP) and other regulatory standards.

The ideal candidate will bring 12+ years of experience in managing clinical trials, focusing on quality assurance, process optimization, and regulatory compliance. A strong background in oncology drug development is highly preferred.

This strategic leadership role is part of our Operational Excellence department, reporting directly to the Head of Clinical Oversight. The successful candidate will be responsible for:

  • Directing an international team of clinical inspection readiness managers, overseeing project management efforts, and fostering collaboration with CROs, trial teams, and quality assurance experts.
  • Crafting and executing comprehensive inspection readiness strategies, maintaining close coordination with trial management and quality assurance teams, and staying abreast of international regulatory developments.
  • Utilizing key performance indicators (KPIs) to monitor and enhance clinical inspection readiness, aligning efforts with organizational objectives and regulatory requirements.
  • Partnering with quality assurance to develop training, establish best practices, and spearhead process and system improvements based on audit and inspection feedback.

The salary range for this position is $180,000 - $220,000 per year, depending on experience and qualifications. We offer a competitive benefits package, including health insurance, retirement savings plan, and paid time off. Genmab's agile working environment prioritizes employee work-life balance and offers collaborative office spaces and remote work options.



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