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Clinical Drug Supply Manager
1 month ago
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 without vendor, and approve 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.
- 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.
- You are passionate about our 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.
