Team size: 70

Jurisdictions your role covers: Global (incl. US, NL, China and Japan)

What are the most significant cases or transactions that your legal team has recently been involved in?

Firstly, it is key to highlight the acquisition of a Dutch/American company, including the implementation of activities, people and entities. Leading and supporting the end-to-end acquisition process, including legal due diligence and contract negotiation. Overseeing post-merger integration across jurisdictions, ensuring alignment of corporate structures, governance, and compliance frameworks. Supporting the integration of employees, business operations, and legal entities, while managing cross-border regulatory requirements and stakeholder expectations.

Secondly, supporting a commercial EU expansion – establishing EU sales entities in Germany, the UK, France, and Switzerland. Advising and executing the establishment of new legal entities across multiple European jurisdictions, including corporate structuring, governance, and regulatory compliance. Supporting the build-out of commercial operations, including contracting frameworks, employment matters, and local legal requirements. Partnering closely with business teams to enable scalable and compliant market entry and ongoing operations.

Furthermore, our team completed the roll-out of a legal AI tool to the legal team members. Driving the implementation of a legal AI solution to enhance efficiency and consistency across the legal function. Leading vendor selection, contract negotiations, and internal governance approvals. Supporting change management efforts, including training, adoption strategies, and development of internal guidelines to ensure responsible and effective use of AI within the legal team.

And, lastly, supporting 24 clinical trials globally. Providing legal support across a global portfolio of clinical trials, including drafting and negotiating clinical trial agreements, site agreements, and vendor contracts. Advising regulatory requirements, data protection, and ethical considerations across multiple jurisdictions. Collaborating with clinical, regulatory, and external partners to ensure compliant and timely execution of trial activities.

How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact?

The acquisition and integration of two different companies (ProfoundBio and Merus), combined with the initiation of multiple late-stage trials, called for a more optimised way of managing contracting activities related to clinical site agreements.

To this end, Genmab Legal initiated the establishment of a new, centralised Contract Management operational team within the team of Development Operations.

This new team will manage site agreements with the goal of standardising processes, clarifying ownership, and enabling more efficient and predictable management of clinical trial site agreements, with the goal of accelerating site start-up to deliver impact for patients faster.

This change is nicely aligned with Genmab Legal’s evolving operating model where our primary focus is on providing focused legal advice and support across the organisation. And as part of this change, the more operational site contract management activities will transition from Legal to Development Operations.

Genmab Legal will continue to support the business on legal risk assessment, complex legal issues, and escalations where legal judgment is required.

What are some of the biggest legal or regulatory challenges currently facing your industry, and how is your team preparing to address them?

Not specific for our industry but the implementation and use of AI across the company requires significant legal support to ensure we are both taken advantage of the opportunities but in a compliant and aligned way.