Clinical Drug Supply Manager

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

Genmab is searching for an experienced 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.

The Clinical Drug Supply Planning teamwork 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 affairs team.

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 reports to the Global Clinical Drug Supply Planning Leader based in Princeton, NJ.

Key responsibilities include

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/participate in 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 - What You Must Have

At least 3 – 5+ years’ experience in setting up and handling clinical drug supply, including forecasting, inventory management, project planning, stakeholder management, and distribution with cold chain management.

Minimum a bachelor’s degree or equivalent.Experience in working with trial management for clinical trial supplies.Knowledge and understanding of GMP, GDP, and GCP.Ability to work successfully under pressure in a fast-paced environment and with tight timelines.A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.

Moreover, you meet the following personal requirements

You are structured and process-orientedYou are proactive, enthusiastic, and goal orientated.You have a quality mindset and are able to prioritize your work in a fast paced and changing environmentYou have good interpersonal and communication skillsYou are able to work independently as well as within global teamsYou are results- and goal-oriented and committed to contributing to the overall success of Genmab

Where you will work

This role will be in Princeton, NJ USA or Copenhagen, DK and requires being within driving commuting distance to work according to Genmab’s hybrid work policy.

When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 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.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

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 https://www.genmab.com/privacy.

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.