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 all trial level inventory and ensuring no stock out situations.
Actively participate in Clinical Trial Team (CTT) activities and meetings and other cross-functional forums to ensure aligned planning and execution.
Early identification of risks and potential delays related to drug supply, inventory, or timelines, and develop mitigation and contingency plans.
Participate in regulatory discussions in relation to IMP/AxMP.
Manage and maintain project/trial specific documentation (i.e. Trial Notification File (TNF), IMP manual, SIV slides, filing in eTMF etc.)
Budget forecasting throughout the trial lifecycle.
Ensure GxP & regulatory guideline compliance 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.
Responsible for being compliant with Genmab’s quality system.

Minimum a bachelor’s degree or equivalent in relevant discipline
Relevant work experience within the Pharmaceutical or biotechnology industry
3+ years’ of experience in clinical trial management or clinical drug supply activities is an advantage, 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 and with tight timelines
Proactive, goal oriented, and able to prioritize tasks effectively
Strong team player with a demonstrated ability to collaborate with a diverse range of internal and external stakeholders
Strong communication skills in English, both written and verbal.

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

Manager, Clinical Drug Supply

Key skills