Clinical Operations Director, Programming Strategy

1 month ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Summary

We are seeking a highly experienced Clinical Operations Director to lead our Programming Strategy team at Genmab. As a key member of our Development Operations Leadership Team, you will be responsible for driving the overall strategy and development areas of the organization.

About the Role

In this role, you will work closely with our HoF Biostatistics and HoF Data Management teams to drive programming activities across clinical and regulatory operations. You will be responsible for establishing standard processes, templates, and clinical standards to ensure quality and timelines of regulatory filings and clinical documentation.

You will also oversee outsourced programming activities, selecting and managing programmers, and ensuring clear expectations and responsibilities are defined in work orders and manuals. Your extensive experience with NDA, MAA, BLA filings is essential for this position.

Key Responsibilities
  • Drive process development and standards within programming.
  • Develop resource planning and outsourcing strategies for programming activities.
  • Prepare and participate in audits and inspections.
  • Contribute to ongoing improvements and lessons learned in cross-functional and global collaboration.
  • Manage and supervise a team of skilled professionals.
Requirements
  • Bachelor's degree or equivalent required.
  • Minimum 15+ years of experience in clinical trial management and 10+ years of people management experience.
  • SAS programming or similar languages such as R, Python, etc.
  • Analytical and problem-solving skills.
Location and Salary

This role can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands and is hybrid. The estimated salary range for this position is $150,000 - $180,000 depending on location and experience.



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