Manager, Global Clinical Drug Supply at Genmab US, Inc.

Copenhagen, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

15 Jun, 26

Salary

0.0

Posted On

17 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Drug Supply Strategy, Inventory Management, Stakeholder Collaboration, CMC, Clinical Trial Team (CTT), CRO Management, CMO Management, Risk Identification, Mitigation Planning, Regulatory Discussions, Documentation Management, Budget Forecasting, GxP Compliance, Audit Preparation, SOP Maintenance, Communication

Industry

Biotechnology Research

Description

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 seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Execution team. This position is open to candidates based in Copenhagen or Princeton who reside within commuting distance of our office locations, supporting regular on-site collaboration as part of our hybrid way of working. Come and immerse yourself in an impressive pipeline and portfolio where you will be part of a team that plays a leading role in the planning and execution of clinical trial supplies and materials. You will apply your expertise to execute drug supply strategies, ensure adequate inventory levels, and collaborate closely with a wide range of stakeholders. Your work will directly support the timely delivery of high-quality clinical trial supplies and help bring innovative medicines to patients with cancer and other serious diseases. In addition, you will partner with key internal stakeholders, including multiple functions within CMC and members of the Clinical Trial Team (CTT), while providing guidance and coordination to external partners such as CROs and CMOs to ensure alignment and successful delivery. You demonstrate strong, professional written and verbal communication skills, enabling clear alignment and ensuring activities are executed as expected. You are an initiative-driven and proactive contributor who takes ownership and accountability for delivering high-quality clinical trial supplies on time from a planning and execution perspective. Operating in a dynamic environment where change is a natural part of the work, you are able to effectively prioritize tasks, balance urgency with importance, and adapt to evolving needs. This is a hybrid position reporting to the Associate Director, Global Clinical Drug Supply Team Lead, based in Copenhagen, DK Responsibilities 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. Requirements 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. Enjoys contributing to team spirit initiatives and actively embraces the collaborative and social culture within Drug Supply. Strong communication skills in English, both written and verbal. The Department 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 US. 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. United by a strong commitment to fighting cancer, we are an international and diverse team that values collaboration and teamwork. We offer an informal working environment characterized by a high pace, strong engagement, and a shared team spirit—where we work hard, support one another, and have fun along the way, both within and across teams and the wider department. We would be excited to hear from you if the above resonates with your experience or interests. About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). 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. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The manager will lead end-to-end trial execution activities from start-up to close out, ensuring timely planning, execution, and delivery of clinical trial supplies aligned with study milestones. This includes maintaining inventory levels, participating in cross-functional teams, identifying risks, and developing mitigation plans.