Senior IRT Manager, Clinical Drug Supply

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 Senior IRT Manager to join our Global Clinical Drug Supply Systems team. In this role, you will provide senior-level leadership for the design, implementation, and lifecycle management of Interactive Response Technology (IRT) solutions supporting Genmab’s global clinical development portfolio.

As a Senior IRT Manager, Global Clinical Drug Supply, you will lead complex and strategically important clinical trial IRT implementations while serving as a subject matter expert across IRT platforms, processes, and standards. You will partner closely with Clinical Operations, Data Management, Clinical Supply, Quality, and external IRT vendors to ensure systems are delivered with the appropriate quality, compliance, scalability, and operational effectiveness throughout the clinical trial lifecycle.

Beyond individual trial delivery, you will contribute to the continued evolution of Genmab’s IRT capabilities by helping shape standards and best practices, evaluating platform changes and emerging capabilities, supporting vendor governance, and leading cross-trial improvement initiatives.

The ideal candidate brings strong IRT and clinical development experience, a solid understanding of GxP and computerized system requirements, and the ability to navigate complex cross-functional and vendor relationships. We are looking for someone who combines technical and operational expertise with proactive problem solving, clear communication, and a strong commitment to quality and ultimately to supporting the patients who participate in Genmab clinical trials.

Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Responsibilities:

IRT Portfolio and Complex Trial Leadership

• Independently lead complex, high-priority, or strategically significant trial-specific IRT systems across the full system lifecycle.
• Provide IRT leadership across programs or related groups of clinical trials where alignment of design, standards, vendors, or operational approaches is required.
• Anticipate portfolio-level risks, dependencies, and opportunities and proactively recommend mitigation or improvement strategies.
• Serve as a senior escalation and consultation resource for IRT Managers on complex design, operational, quality, and vendor issues.
• Lead resolution of significant IRT issues requiring cross-functional coordination and independent judgment.

IRT Platform and Standards Leadership

• Serve as subject matter expert for one or more IRT platforms, processes, standards, or technical capability areas.
• Lead or significantly contribute to development, refinement, and implementation of IRT standards, best practices, procedures, and training.
• Evaluate vendor platform changes and new capabilities and assess operational, compliance, and trial impacts.
• Lead assigned platform enhancements, validation activities, or other cross-trial system initiatives in partnership with GCDS Systems leadership.
• Analyze cross-trial trends and lessons learned to identify systemic risks and opportunities for standardization.

Vendor and Governance Leadership

• Lead operational vendor governance activities for assigned platforms, programs, or areas of responsibility.
• Analyze vendor KPIs, recurring issues, quality trends, and delivery performance and recommend corrective or preventive action.
• Lead complex problem resolution, root-cause analysis, investigations, and remediation involving IRT vendors and internal stakeholders.
• Provide significant input to vendor evaluations, audits, inspections, and service improvement activities.

Quality and Inspection Readiness

• Provide senior oversight of inspection readiness across assigned trials and platform responsibilities.
• Lead preparation and response activities for IRT-related audits and inspections as assigned.
• Lead or support quality events, CAPAs, risk assessments, and remediation activities involving IRT systems.
• Promote consistent application of validation, documentation, records-retention, and data-integrity expectations.

Leadership and Development

• Mentor and coach IRT Managers and Senior Associates, supporting development of technical judgment, independence, and problem-solving capability.
• Lead cross-functional initiatives and represent IRT in operational forums as assigned.
• Lead continuous improvement initiatives that increase quality, scalability, efficiency, or consistency across the IRT portfolio.
• Provide input to portfolio prioritization and resource planning based on workload, complexity, and risk.
• Responsible to be compliant with Genmab's quality system.

Qualifications:

• Bachelor’s degree or equivalent, preferably within life sciences, supply chain, pharmaceutical sciences, RTSM/IRT, or a related field.
• 7-10+ years of experience from a regulated biotech, pharma clinical supply, supply chain, or similar environment.
• Extensive knowledge and understanding of GMP, GDP, GCP, and documentation standards in a regulated environment.
• Proven ability to drive cross-functional projects and collaborate effectively in global, virtual, and matrixed teams.
• Strong ability to prioritize, create structure, and drive decisions in a fast-paced environment with tight timelines and competing priorities.
• Curious, self-driven, and confident in challenging assumptions, escalating risks, and speaking up when something does not add up.
• Strong communication skills in English, both oral and written.

For US based candidates, the proposed salary band for this position is as follows:

$131,040.00---$196,560.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

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.

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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.