Director, Data Quality and Process, External Data Clinical Data Management
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! The Role The Director, Data Quality and Process, External Data Clinical Data Management, is a strategic leadership role responsible for defining and driving the vision for external data quality, operational excellence, vendor oversight, and process standardization across Genmab's global clinical development portfolio. As a member of the External Data Management Leadership Team, this role partners closely with Clinical Data Management, Clinical Operations, Biomarker Operations, Medical, Biostatistics, Clinical Programming, Regulatory, and external partners to ensure efficient acquisition, integration, quality, and governance of external clinical data throughout the study lifecycle. The Director establishes scalable processes, drives continuous improvement, ensures inspection readiness, and leads enterprise initiatives that strengthen quality, consistency, compliance, and operational execution across all clinical programs. Responsibilities 1. Strategic Leadership and Portfolio Governance Serve as the functional leader for External Data Quality and Process across the clinical development portfolio. Develop and execute the strategic roadmap for external data quality, operational excellence, and process governance. Drive portfolio consistency through standardized processes, governance models, metrics, and best practices. Lead cross-functional initiatives supporting organizational growth, scalability, and operational excellence. Provide strategic recommendations to senior leadership regarding external data strategy, operational risks, and quality improvements. Champion a culture of continuous improvement and operational excellence across Development Operations. 2. External Data Quality and Process Excellence Lead development, implementation, and governance of external data management processes, standards, SOPs, work instructions, and guidance documents. Ensure consistent implementation of external data standards across all studies and vendors. Drive initiatives that improve data quality, streamline external data flows, reduce operational risk, and enhance inspection readiness. Lead lessons learned activities and translate findings into sustainable process improvements. Evaluate emerging technologies, automation, AI solutions, and industry best practices to improve operational efficiency. 3. Vendor Strategy and Operational Oversight Provide strategic oversight of CROs and external data vendors supporting clinical trials. Develop vendor oversight models, KPIs, KQIs, governance processes, and performance metrics. Lead vendor qualification activities, RFP evaluations, bid defenses, and review of Statements of Work. Partner with vendors to improve quality, operational consistency, issue resolution, and innovation. Ensure vendor processes align with Genmab standards and regulatory expectations. Escalate significant operational risks and drive resolution through governance committees when appropriate. 4. Cross-functional Leadership Build strong partnerships across Clinical Data Management, Clinical Operations, Medical, Biomarker Operations, Clinical Programming, Biostatistics, Regulatory, Quality Assurance, and Development Operations. Lead cross-functional governance meetings supporting external data strategy and execution. Ensure alignment between business processes, technology solutions, and operational objectives. Influence organizational decision-making by providing expertise in external data management and operational risk. 5. Inspection-Readiness, Quality and Compliance Lead inspection readiness strategy for External Data Management. Ensure external data processes comply with ICH-GCP, GCDMP, regulatory guidance, and Genmab quality standards. Support regulatory inspections, audits, root cause analyses, CAPAs, and continuous quality improvement activities. Monitor portfolio quality trends and implement proactive mitigation strategies. 6. Operational Excellence and Knowledge Management Develop portfolio-wide onboarding programs and role-based training. Lead development of functional playbooks, guidance documents, templates, and standards libraries. Promote knowledge sharing and consistency across internal teams and external partners. Mentor team members and contribute to development of future leaders within External Data Management. Foster a collaborative environment focused on innovation, accountability, and continuous learning. Additional Responsibilities: Drive alignment meetings within the data management group to ensure consistency of data management practices across trials within an asset and/or within the trials conducted by a DM vendor/partner Represent Clinical Data Management on cross-functional governance committees. Represent Genmab on industry initiatives and external working groups as appropriate. Maintain awareness of evolving industry trends, technologies, regulatory expectations, and best practices. Support departmental objectives and strategic initiatives as assigned. Serve as Subject Matter Expert for External Data Quality Management. Requirements Bachelor's degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred. Minimum 15 years of clinical research or clinical data management experience. Minimum 5 years in strategic leadership within Clinical Data Management or External Data Management. Extensive experience managing external clinical data including laboratories, imaging, eCOA, IRT, biomarkers, wearables, and other third-party data sources. Experience leading global CRO and vendor oversight. Experience developing clinical data management standards, processes, and governance. Experience supporting regulatory inspections and submission readiness. Strong understanding of end to end trial conduct Strong Project Management capability, strategic planning and portfolio thinking Operational excellence and process improvement mindset Cross functional alignment and communication Problem solving, critical thinking and decision making Knowledge of EDC systems, ICH GCP, GDMP, and regulatory expectations Oncology experience strongly preferred. For US based candidates, the proposed salary band for this position is as follows: $189,200.00 $283,800.00 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 . click apply for full job details
