Senior IRT Manager, Clinical Drug Supply

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 3Independently lead complex, high-priority, or strategically significant trial-specific IRT systems across the full system lifecycle. 3Provide IRT leadership across programs or related groups of clinical trials where alignment of design, standards, vendors, or operational approaches is required. 3Anticipate portfolio-level risks, dependencies, and opportunities and proactively recommend mitigation or improvement strategies. 3Serve as a senior escalation and consultation resource for IRT Managers on complex design, operational, quality, and vendor issues. 3Lead resolution of significant IRT issues requiring cross-functional coordination and independent judgment. IRT Platform and Standards Leadership 3Serve as subject matter expert for one or more IRT platforms, processes, standards, or technical capability areas. 3Lead or significantly contribute to development, refinement, and implementation of IRT standards, best practices, procedures, and training. 3Evaluate vendor platform changes and new capabilities and assess operational, compliance, and trial impacts. 3Lead assigned platform enhancements, validation activities, or other cross-trial system initiatives in partnership with GCDS Systems leadership. 3Analyze cross-trial trends and lessons learned to identify systemic risks and opportunities for standardization. Vendor and Governance Leadership 3Lead operational vendor governance activities for assigned platforms, programs, or areas of responsibility. 3Analyze vendor KPIs, recurring issues, quality trends, and delivery performance and recommend corrective or preventive action. 3Lead complex problem resolution, root-cause analysis, investigations, and remediation involving IRT vendors and internal stakeholders. 3Provide significant input to vendor evaluations, audits, inspections, and service improvement activities. Quality and Inspection Readiness 3Provide senior oversight of inspection readiness across assigned trials and platform responsibilities. 3Lead preparation and response activities for IRT-related audits and inspections as assigned. 3Lead or support quality events, CAPAs, risk assessments, and remediation activities involving IRT systems. 3Promote consistent application of validation, documentation, records-retention, and data-integrity expectations. Leadership and Development 3Mentor and coach IRT Managers and Senior Associates, supporting development of technical judgment, independence, and problem-solving capability. 3Lead cross-functional initiatives and represent IRT in operational forums as assigned. 3Lead continuous improvement initiatives that increase quality, scalability, efficiency, or consistency across the IRT portfolio. 3Provide input to portfolio prioritization and resource planning based on workload, complexity, and risk. 3Responsible to be compliant with Genmab's quality system. Qualifications: 3Bachelor's degree or equivalent, preferably within life sciences, supply chain, pharmaceutical sciences, RTSM/IRT, or a related field. 37-10+ years of experience from a regulated biotech, pharma clinical supply, supply chain, or similar environment. 3Extensive knowledge and understanding of GMP, GDP, GCP, and documentation standards in a regulated environment. 3Proven ability to drive cross-functional projects and collaborate effectively in global, virtual, and matrixed teams. 3Strong ability to prioritize, create structure, and drive decisions in a fast-paced environment with tight timelines and competing priorities. 3Curious, self-driven, and confident in challenging assumptions, escalating risks, and speaking up when something does not add up. 3Strong 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: 3401(k) Plan: 100% match on the first 6% of contributions 3Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance 3Voluntary Plans: Critical illness, accident, and hospital indemnity insurance 3Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave 3Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support 3Additional 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