Clinical Supply Chain Manager
5 days ago
At Genmab, we're committed to delivering innovative therapies that transform the lives of patients and change the future of cancer treatment.
We're seeking an experienced Clinical Supply Chain Manager to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton, NJ. As a key member of our team, you'll be responsible for managing outsourcing of packaging, labeling, and distribution of clinical trial supplies for early as well as late-stage Genmab clinical trials.
The Role & Department
You'll work 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 ideal candidate will have extensive knowledge of cGMP and a focus on the level of quality in work performed.
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 without vendor and approval of label proofs/designs.
- Manage set-up of distribution framework through service providers.
- 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 of 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.
- Experience working with IST and PAA from a Sponsor perspective will be an advantage.
- Excellent communication skills in English - both oral and written.
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