Associate Director, External Data Quality Manager

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 Associate Director, External Data Quality Management, is a strategic leadership role supporting high-quality execution of Genmab’s clinical trial portfolio. This individual is accountable for driving the strategy, quality, and integrity of external data across the clinical programs.

The Associate Director will guide cross‑functional teams, oversee external data quality and vendor performance, as well as champion harmonized operational approaches that strengthen trial delivery, inspection readiness, and decision‑making.

Responsibilities:

1.  Portfolio and Strategic Leadership

• Serve as a portfolio‑level lead for external data quality and clinical data‑related operational strategy.

• Drive consistency of processes, quality expectations, and documentation across studies, assets, and vendors.

• Solve complex operational issues by gathering detailed inputs, synthesizing technical and business considerations, formulating data-driven recommendations, securing cross-functional alignment, and leading effective implementation.

• Influence portfolio‑level decision making by providing strategic insights on risks, timelines, and data‑dependent operational impacts.

• Contribute to asset‑level planning, governance forums, and clinical development strategy discussions.

2.  External Data Quality Oversight

• Oversee portfolio‑level strategy for acquisition, integration, and quality oversight of third‑party data (e.g., central/local labs, eCOA, imaging, biomarkers).

• Provide expert review of protocol requirements, vendor specifications, and operational data flows.

• Lead proactive data quality surveillance and escalation management.

3.  Cross-functional Collaboration

• Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure aligned execution and issue resolution.

• Ensure operational readiness and cross‑functional understanding of external data processes, timelines, and deliverables.

• Participate in governance forums and asset-level data planning initiatives.

4.  Process Excellence and Standardization

• Drive continuous improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management.

• Lead the development, implementation, and governance of standardized processes, playbooks, RACI models, and best practices.

• Identify operational bottlenecks and deliver scalable solutions at portfolio level.

5.  Vendor and Partnership Oversight

• Provide strategic oversight of external vendors handling clinical data; focus on operational performance, quality compliance, and cross‑trial consistency.

• Represent External Data Quality Management on Operational Committees with CROs or external data vendors.

6.  Regulatory and Submission Support

• Contribute to regulatory submission strategy, ensuring external data and associated processes meet inspection and documentation requirements.

• Provide asset‑level oversight of data‑related deliverables for submissions.

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

• Contribute to the development of best practices/SOPs within Genmab Clinical Data Management, aligned with industry and regulatory best practices

• Provide subject matter expertise to various task forces and initiatives

• Act as Portfolio Asset External Data Quality Management Lead as required.

• Mentor and develop new team members

Qualifications:

• Bachelor’s degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.

• Minimum of 10 years of experience in clinical operations, clinical data management, or other related clinical research experience with at least 3–5 years in oversight and leadership roles.

• 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

• Vendor oversight and partnership management

• Problem solving, critical thinking and decision making

• Knowledge of EDC systems, ICH‑GCP, GDMP, and regulatory expectations

• Experience in oncology preferred.

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

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 

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

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.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

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.