At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Genmab is searching for an experienced Senior Clinical Drug Supply Manager to be part of Global Clinical Drug Supply (GCDS) Planning in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.
Come and immerse yourself in an impressive pipeline and portfolio, where you will have the opportunity to be part of the team that is in the leading role in the planning of clinical trial supplies and materials. The individual will have the ability to exercise their skills and knowledge on forecasting, scenario planning, and stakeholder management. Leading and supporting this type of work will allow the individual to be at the forefront of bringing medicines to cancer patients and other serious disease.
Senior Clinical Drug Supply Manager team will work in partnership with several internal and external stakeholders, including GCDS Operations, GCDS Systems, Development Operations, Portfolio & Project Management, and CMC. The role will also help guide CROs, CMOs, clinical site personnel, and medical affair steam.
You are skilled in professional and clear written and oral communication to ensure activities are carried out as per expectation. You must be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from a planning perspective. Changes are a natural part of our work, so you are able prioritize your tasks and balance importance with urgency.
The position is hybrid and reports to the Global Clinical Drug Supply Planning Leader based in Princeton, NJ.

Responsibilities

• Obtain Project/Trial specific information to initiate drug supply strategic planning and execution, and maintain information on changing clinical development plan
• Identify risks for delays for projects/programs and trials and possible mitigations (contingency plans and new/additional scenarios) that may impact clinical drug supply)
• Create and maintain program/project plans, trial IMP/AxMP forecast and demand plans, and budgets throughout the trial lifecycle
• Maintain all project/program trial level inventory and ensuring no stock out situations.
• Lead and participate in cross functional teams and support strategic cross functional collaboration (i.e., project/program and trials)
• Lead Clinical Project Supply Team discussions.
• Participate in regulatory discussions in relation to IMP/AxMP
• Manage project/trial specific planning documentation (i.e., drug supply plan, milestone tracking, IMP manual, etc.)
• Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables
• Support inspection and audit preparation and execution.
• Participate in maintenance of SOPs.
• Responsible to be compliant with Genmab´s quality system.

REQUIREMENTS

• Minimum a bachelor’s degree or equivalent.
• Advantage with 6+ years’ experience in handling clinical drug supply, including forecasting, demand planning, budgeting, and project planning
• Experience in working with trial management for clinical trial supplies.
• Knowledge and understanding of GMP, GDP, and GCP.
• Proven experience working in teams.
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
• Ability to be proactive, enthusiastic, and goal orientated.
• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
• Strong communication skills in English - both oral and written.

• Obtain Project/Trial specific information to initiate drug supply strategic planning and execution, and maintain information on changing clinical development plan
• Identify risks for delays for projects/programs and trials and possible mitigations (contingency plans and new/additional scenarios) that may impact clinical drug supply)
• Create and maintain program/project plans, trial IMP/AxMP forecast and demand plans, and budgets throughout the trial lifecycle
• Maintain all project/program trial level inventory and ensuring no stock out situations.
• Lead and participate in cross functional teams and support strategic cross functional collaboration (i.e., project/program and trials)
• Lead Clinical Project Supply Team discussions.
• Participate in regulatory discussions in relation to IMP/AxMP
• Manage project/trial specific planning documentation (i.e., drug supply plan, milestone tracking, IMP manual, etc.)
• Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables
• Support inspection and audit preparation and execution.
• Participate in maintenance of SOPs.
• Responsible to be compliant with Genmab´s quality system