Clinical Drug Supply Manager

Job title:

Clinical Drug Supply Manager

Company:

Genmab

Job 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 a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton or Copenhagen within commute distance from our office locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/Trial ManagementObtain Project/Trial specific information to initiate drug supply strategic planning and execution, and maintain information on changing clinical development planIdentify 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 and trial IMP/AMP forecast and demand plans throughout the trial lifecycleMaintain all project/program trial level inventory and ensuring no stock out situationsCreate and maintain program/project and trial budget forecast throughout the trial lifecycleLead and participate in cross functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross functional collaboration (i.e., project/program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in relation to IMP/AMPManage 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 deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation area including implementation of new regulations in the departmentProvide SME knowledge supportCoach and mentor colleagues during onboarding and maintenance of trainingResponsible for oversight and resolution of deviations, CAPAs and change controls in connection to Clinical Drug Supply OperationDrive Inspection and Audit preparation and executionResponsible to be compliant with Genmab’s quality systemRequirementsMinimum a Bachelors with 3-5 years experience. Master’s degree with +2 years experiences, or PhD’s degree with +1 year of experience, or equivalent of experience.Experience in handling supply chain, manufacturing, ERP, clinical supply chain, operations, logistics, preferably in the pharmaceutical or biopharmaceutical industry.Broad and Diverse experience in working with trial management for global clinical drug supply and supply functionsKnowledge and understanding of GMP, GDP, and GCP. Supply Chain systems and processes.Strong desire to exploit emerging technologies for better business outcomes.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.The TeamYou will be part of a highly competent team focused on planning and maintenance of supplies for clinical trials, working closely with the Global Clinical Drug Supply Operations & System team and our cross-functional stakeholders.Together with Global Clinical Drug Supply Operations & Systems team the three teams make up the Global Clinical Drug Supply department.We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can 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!LocationsGenmab 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 GenmabGenmab 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 and .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 .

Expected salary

Location

København

Job date

Thu, 03 Apr 2025 02:54:28 GMT

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