Clinical Supply Chain Manager

1 month ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a key member of our team, you will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early and late-stage Genmab clinical trials.

Key Responsibilities
  • Manage and coordinate drug supply and provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
  • Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
  • Set up English Master Label, manage label translation with vendors, and approve label proofs/designs.
  • Manage the setup of distribution frameworks through service providers.
  • Define appropriate drug supply activities at CMOs necessary for providing drug supplies for clinical trials.
  • Contribute to the maintenance of SOPs and Work Instructions in the department.
  • Perform training of other team members.
  • Function as a Subject Matter Expert within relevant areas.
  • Ensure compliance with Genmab's quality system.
Requirements
  • At least 3 years' experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
  • Ability to manage stakeholders internally and externally.
  • Experience working with CMOs for clinical trial supplies.
  • Training in GDP, GMP, and GCP is a requirement.
  • Experience working with IST and PAA from a Sponsor perspective is an advantage.
  • Excellent communication skills in English - both oral and written.
About You
  • You are passionate about Genmab's purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.
Locations

Genmab leverages the effectiveness of an agile working environment, when possible, 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.

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