IRT Manager

Role Overview

Genmab is looking for an experienced Clinical Drug Supply Manager to join the Global Clinical Drug Supply (GCDS) Execution team. The role will be based in Copenhagen or Princeton, Denmark or the United States, and requires regular on‑site collaboration as part of a hybrid working model. The manager will support the planning and execution of clinical trial supplies and materials, ensuring timely delivery of high‑quality clinical trial supplies and contributing to the success of innovative medicines for cancer and other serious diseases.

The position reports to the Associate Director, Global Clinical Drug Supply Team Lead (Copenhagen).

• Lead end‑to‑end trial execution activities from start‑up to close out.
• Gather and maintain up‑to‑date project and trial information to support the execution of clinical drug supply strategies.
• Ensure timely planning, execution and delivery of clinical trial supplies in alignment with study milestones and program strategy.
• Maintain trial‑level inventory and prevent stock‑out situations.
• Actively participate in Clinical Trial Team (CTT) activities, meetings and cross‑functional forums to ensure aligned planning and execution.
• Identify early risks and potential delays related to drug supply, inventory or timelines, and develop mitigation and contingency plans.
• Participate in regulatory discussions concerning IMP/AxMP.
• Manage and maintain project/trial specific documentation (e.g., Trial Notification File (TNF), IMP manual, SIV slides, eTMF filing).
• Forecast budgets throughout the trial lifecycle.
• Ensure compliance with GxP and regulatory guidelines during all drug supply planning tasks, activities and deliverables.
• Support inspection and audit preparation and execution.
• Participate in maintenance of SOPs.
• Participate in internal and cross‑functional improvement projects.
• Ensure compliance with Genmab’s quality system.

• Minimum a bachelor’s degree or equivalent in a relevant discipline.
• Relevant work experience within the pharmaceutical or biotechnology industry.
• 3+ years of experience in clinical trial management or clinical drug supply, including day‑to‑day forecasting, IRT systems, budgeting and stakeholder management within CMC and clinical development.
• Solid knowledge and understanding of GCP, GMP and GDP.
• Ability to work effectively in a fast‑paced environment with tight timelines.
• Proactive, goal‑oriented and able to prioritize tasks effectively.
• Strong team player with demonstrated ability to collaborate with a diverse range of internal and external stakeholders.
• Strong communication skills in English, both written and verbal.

The Global Clinical Drug Supply (GCDS) department consists of four highly collaborative teams – GCDS Execution, Strategy, Manufacturing and Systems – with colleagues based in both Denmark and the United States. As a Clinical Drug Supply Manager, you will work closely with colleagues across these teams on a day‑to‑day basis to ensure seamless and efficient planning and execution of clinical drug supply activities.

For US‑based candidates the proposed salary band is $ – $.

• 401(k) Plan: 100% match on the first 6% of contributions.
• Health Benefits:
  
  Two medical plan options (including HDHP with HSA), dental and vision insurance.
• Voluntary Plans:
  Critical illness, accident and hospital indemnity insurance.
• Time Off:
  Paid vacation, sick leave, holidays and 12 weeks of discretionary paid parental leave.
• Support Resources:
  Access to child and adult backup care, family support programs, financial wellness tools and emotional well‑being support.
• Additional Perks:
  Commuter benefits, tuition reimbursement and a Lifestyle Spending Account for wellness and personal expenses.

Copenhagen, Denmark or Princeton, New Jersey, United States. The role operates in a hybrid model requiring regular on‑site collaboration.