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, Denmark or Princeton, New Jersey. 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 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.
- 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.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
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Clinical Drug Supply Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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, labelling, and distribution of clinical trial supplies for Genmab's early and late-stage...
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