Clinical Supply Chain Manager

2 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

At Genmab, we're committed to building extraordinary futures together by developing innovative antibody products and pioneering therapies that change the lives of patients with cancer and other serious diseases. As a leading biotechnology company, we strive to improve the lives of people around the world.

The role is part of our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. The ideal candidate will have at least 3 years' experience in handling clinical drug supply, including setting up label text and handling ancillaries. A strong background in GDP, GMP, and GCP is essential, along with excellent communication skills in English.

The successful candidate will be responsible for managing outsourcing of packaging, labeling, and distribution of clinical trial supplies for early as well as late-stage Genmab clinical trials. This includes working closely with GMP QA and our CMOs to ensure timely packaging and labeling for our clinical trials as well as IST and PAA for patients with cancer and other serious diseases.

The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen. We offer a competitive salary range of $85,000 - $110,000 per year, depending on qualifications and experience.

About the Role

  • Manage and coordinate drug supply and provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
  • Set up English Master Label, manage label translation without vendor, and approval of label proofs/designs.
  • Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
  • Contribute to maintenance of SOPs and Work Instructions in the department.
  • Perform training of other team members.
  • Function as Subject Matter Expert within relevant areas.
  • Responsible for being compliant with Genmab's quality system.

Requirements

  • At least 3 years' experience in handling clinical drug supply, including setting up label text and handling ancillaries.
  • Ability to manage stakeholders internally and externally.
  • Experience working with CMO for clinical trial supplies.
  • Training in GDP, GMP, and GCP is a requirement.
  • Excellent communication skills in English - both oral and written.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you're passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment, please apply today.



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