Clinical Drug Supply Manager

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:

• 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 and trial IMP/AMP forecast and demand plans throughout the trial lifecycle
• Maintain all project/program trial level inventory and ensuring no stock out situations
• Create and maintain program/project and trial budget forecast throughout the trial lifecycle
• Lead and participate in cross functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross functional collaboration (i.e., project/program and trials
• Lead/Participate in Clinical Project Supply Team discussion
• Participate in regulatory discussions in relation to IMP/AMP
• 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

Global Clinical Drug Supply:

• Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation area including implementation of new regulations in the department
• Provide SME knowledge support
• Coach and mentor colleagues during onboarding and maintenance of training
• Responsible for oversight and resolution of deviations, CAPAs and change controls in connection to Clinical Drug Supply Operation
• Drive Inspection and Audit preparation and execution
• Responsible to be compliant with Genmab’s quality system

Requirements

• Minimum 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 functions
• Knowledge 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 Team

You 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.

For US based candidates, the proposed salary band for this pos