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 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Develop portfolio-wide onboarding programs and role-based training.
• Lead development of functional playbooks, guidance documents, templates, and standards…