Senior Clinical Drug Supply Manager

Role Summary

Senior Clinical Drug Supply Manager responsible for ensuring timely delivery of high-quality clinical trial supplies for early and late-stage Genmab trials. Oversees packaging and labeling, reviews GxP documentation, and collaborates with CMOs and GMP QA to maintain quality standards. Hybrid role based in Copenhagen or Princeton with 60% office presence.

Responsibilities

• Manage and coordinate drug supply and provide IMP for clinical trials.
• Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
• Set-up English Master Label, manage label translation with 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‚Äôs quality system.

Qualifications

• Bachelor‚Äôs degree in a relevant field (e.g., Pharmaceutical Sciences, Life Sciences, Healthcare, or Supply Chain Management).
• Minimum 3 years of experience in clinical drug supply management, including label text setup, ancillary handling.
• Demonstrated stakeholder management skills, both internally and externally.
• Experience working with vendors and CMOs for clinical trial supplies will be an advantage.
• Solid knowledge of GDP and GMP. Knowledge of GCP will be an advantage.
• Strong problem-solving skills with the ability to excel in a fast-paced, deadline-driven environment.
• Excellent communication skills in English, both written and spoken.
• Highly organized with a structured, process-oriented mindset that supports continuous improvement.
• Ability to prioritize effectively while maintaining a high level of quality and compliance.
• Strong interpersonal skills with the ability to work both independently and within global teams.
• Results-driven and goal-oriented, committed to contributing to Genmab‚Äôs success.

Skills

• Drug supply management
• Packaging and labeling coordination
• GxP documentation review and approval
• CMO/vendor management
• GDP/GMP knowledge
• Communication and collaboration
• Problem-solving and continuous improvement

Education

• Bachelor‚Äôs degree in a relevant field

Additional Requirements

• Hybrid working arrangement; must be able to be in the office 60% of the time.
• Location within commuting distance of Copenhagen or Princeton or willingness to relocate.