Associate Director, External Data Quality Manager

At Genmab we are dedicated to building extranotordinary 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 Genmabs 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 crossfunctional teams oversee external data quality and vendor performance as well as champion harmonized operational approaches that strengthen trial delivery inspection readiness and decisionmaking.

Responsibilities:

1. Portfolio and Strategic Leadership

• Serve as a portfoliolevel lead for external data quality and clinical datarelated 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 portfoliolevel decision making by providing strategic insights on risks timelines and datadependent operational impacts.

• Contribute to assetlevel planning governance forums and clinical development strategy discussions.

2. External Data Quality Oversight

• Oversee portfoliolevel strategy for acquisition integration and quality oversight of thirdparty 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 crossfunctional 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 crosstrial 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 assetlevel oversight of datarelated 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:

• Bachelors 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 35 years in oversight and leadership roles.

• Strong understanding of endtoend trial conduct

• Strong Project Management capability

• Strategic planning and portfolio thinking

• Operational excellence and process improvement mindset

• Crossfunctional alignment and communication

• Vendor oversight and partnership management

• Problem solving critical thinking and decision making

• Knowledge of EDC systems ICHGCP 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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.