Senior IRT Manager

At Genmab we are dedicated to building extranotordinary 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!

The Role & Department

Genmab is seeking an experienced Senior IRT/System Manager to join our Global Clinical Drug Supply Technical Operations team. The position as IRT Manager is in Copenhagen. The role requires onsite presence 3 days/week according company policy

With a strong pipeline and numerous ongoing clinical trials you will play a key role in IRT Managementensuring timely and high-quality clinical trial supplies for both early- and late-stage studies that support patients battling cancer and other serious diseases.

We are looking for proactive solution-oriented professionals who thrive in dynamic environments can balance priorities and adapt quickly to change. Our workplace is international fast-paced and collaborativedriven by a strong one team spirit both within and across departments.

Responsibilities

IRT Platform Management
Define and maintain IRT standards best practices and training in close alignment with governance for internal and external use
Ensure compliance qualification validation and ongoing oversight of Genmabs IRT systems throughout their lifecycle
Monitor vendor updates identify process improvements and contribute to streamlined timelines

IRT Portfolio & Project Management
Oversee the full lifecycle of trial-specific IRT systems (setup maintenance decommissioning).
Coordinate IRT implementation protocol-driven requirements UAT planning/execution integrations documentation and training.
Ensure adherence to IRT system standards and proactively manage risks.
Oversee multiple projects ensuring schedules and deliverables are met in collaboration with cross-functional stakeholders.
Communicate project status effectively and participate in operational planning sessions.

IRT Vendor Management
Act as Supplier Relationship Manager for IRT vendors.
Support KPIs metrics and trend analysis to anticipate and mitigate risks.
Provide oversight of vendor activities ensuring quality and compliance.
Collaborate with vendor project managers and participate in audits and inspection readiness.
Facilitate problem resolution root cause analysis and corrective actions.

Continuous Improvement
Identify opportunities to improve processes and lead assigned initiatives.
Mentor and train IRT team members; support cross-functional training.
Contribute to documentation development and maintenance (SOPs work instructions job aids).

Requirements
Bachelors degree in a scientific or technical field; advanced degree/certification preferred.
6 years experience in supply chain or related areas within pharma biotech or medical devices.
Strong knowledge of regulatory standards (e.g. GMP GCP ICH).
Hands-on experience with IRT systems.
Proven ability to manage large complex projects with multiple stakeholders.
Experience working in cross-functional multicultural teams.

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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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