Data Process & Management

About The Company

• Genmab is an international biotechnology company focused on developing innovative antibody therapeutics designed to improve the lives of patients with cancer and other serious diseases. Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific.
• The company combines antibody technology platforms with translational, quantitative, and data sciences to develop next-generation medicines. Genmab promotes a collaborative, innovative, and purpose-driven culture where employees are encouraged to contribute their expertise while advancing meaningful scientific and clinical outcomes.

About The Role

• Genmab is seeking a Director, Data Quality and Process, External Data Clinical Data Management to provide strategic leadership across external clinical data quality, operational excellence, vendor oversight, and process governance.
• This senior leadership role will lead the strategic roadmap for external data management across Genmab's global clinical development portfolio. The Director will work closely with Clinical Data Management, Clinical Operations, Biomarker Operations, Medical, Biostatistics, Clinical Programming, Regulatory, Quality Assurance, and external partners.
• The role will focus on strengthening data quality, standardizing processes, improving vendor performance, supporting inspection readiness, and implementing scalable solutions across clinical programs. The position also provides an opportunity to evaluate emerging technologies, automation, and AI solutions that can improve operational efficiency and data governance.

Responsibilities

• Serve as the functional leader for External Data Quality and Process across the global clinical development portfolio
• Develop and execute the strategic roadmap for external data quality, operational excellence, and process governance
• Establish standardized processes, governance models, metrics, and best practices across clinical programs
• Provide strategic recommendations to senior leadership regarding external data strategy, operational risks, and quality improvements
• Develop and govern external data management processes, SOPs, work instructions, standards, and guidance documents
• Drive initiatives that improve external data quality, streamline data flows, reduce operational risks, and strengthen inspection readiness
• Lead lessons-learned activities and translate findings into sustainable process improvements
• Evaluate emerging technologies, automation, AI solutions, and industry best practices
• 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 Statement of Work reviews
• Partner with vendors to improve quality, consistency, issue resolution, and innovation
• Lead cross-functional governance meetings supporting external data strategy and execution
• Build strong partnerships across Clinical Data Management, Clinical Operations, Medical, Biomarker Operations, Clinical Programming, Biostatistics, Regulatory, Quality Assurance, and Development Operations
• Ensure alignment between business processes, technology solutions, and operational objectives
• Lead inspection-readiness strategies for External Data Management
• Support regulatory inspections, audits, root cause analyses, CAPAs, and continuous quality improvement activities
• Monitor portfolio quality trends and implement proactive mitigation strategies
• Develop onboarding programs, functional playbooks, templates, guidance documents, and standards libraries
• Promote knowledge sharing and consistency across internal teams and external partners
• Mentor team members and contribute to leadership development within External Data Management
• Represent Clinical Data Management on cross-functional governance committees and relevant industry working groups
• Serve as a subject matter expert for External Data Quality Management

Qualifications

• Bachelor's degree in a scientific, technical, or health-related field
• Advanced degree such as an MS or PhD preferred
• 15+ years of clinical research or clinical data management experience
• At least 5 years of strategic leadership experience 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 frameworks
• Experience supporting regulatory inspections and submission readiness
• Strong understanding of end-to-end clinical trial conduct
• Strong project management and strategic planning capabilities
• Portfolio-level strategic thinking and operational excellence mindset
• Strong process improvement and problem-solving abilities
• Excellent cross-functional communication and stakeholder management skills
• Strong critical thinking and decision-making capabilities
• Knowledge of EDC systems, ICH-GCP, GCDMP, and regulatory expectations
• Strong understanding of clinical data quality and governance
• Oncology experience strongly preferred

Benefits

• Competitive salary range of $189,200 - $283,800 for U.S.-based candidates
• Potential eligibility for discretionary bonuses and long-term incentives
• 401(k) plan with 100% company match on the first 6% of contributions
• Two medical plan options, including an HDHP with HSA
• Dental and vision insurance
• Critical illness, accident, and hospital indemnity insurance options
• Paid vacation, sick leave, and holidays
• 12 weeks of discretionary paid parental leave
• Child and adult backup care
• Family support programs
• Financial wellness resources
• Emotional well-being support
• Commuter benefits
• Tuition reimbursement
• Lifestyle Spending Account for wellness and personal expenses
• Opportunities for professional development and leadership growth
• Opportunity to work on innovative clinical data and biotechnology initiatives

Equal Opportunity

Genmab is committed to creating an inclusive, collaborative, and respectful workplace where individuals' unique contributions are valued. We support equal employment opportunities and encourage qualified professionals from diverse backgrounds to contribute to our mission of developing innovative medicines for cancer and other serious diseases.