Associate Director, Global Trial Lead

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At Genmab, we are dedicated to building extraordinary 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.

As the Associate Director Global Trial Lead (GTL) you are responsible for the end‑to‑end delivery of one or more clinical trials, from initial strategy to Clinical Study Report (CSR) completion. This includes leading cross‑functional Clinical Trial Teams (CTT), managing budgets, and leveraging matrix leadership to align internal and external stakeholders in achieving trial goals efficiently and to high‑quality standards. The GCTM serves as the main coordinator for the Trial Team and may take on Clinical Trial Manager (CTM) responsibilities if no CTM is assigned.

• Lead the cross functional Clinical Trial Team (CTT) including roles such as Medical, Biostatistics, Programming, and Data Management.
• Lead the operational Trial Team, including roles such as Start‑up Specialists, Clinical Trial Associates (CTA), and Clinical Trial Managers (CTM).
• Manage CTT resources/membership, assign tasks, and ensure deadlines are met.
• Make tactical decisions within scope to ensure that CTT work aligns with program objectives.
• Define and manage CTT goals in collaboration with team members.
• Provide regular updates, reports, and escalations to the DOPL regarding progress, challenges, risks, and resource needs.
• Review and approve key trial documents, including protocols, amendments, plans, and manuals.
• Oversee vendor selection and manage trial‑related contracts and amendments.
• Drive country selection and coordinate responses to IEC/IRB comments.
• Maintain trial integrity by ensuring protocol adherence and addressing data trends.
• Collaborate with the Development Operations Program Lead (DOPL) on cross‑functional clinical development team activities and elevate issues as needed.
• Execute strategies for drug supply, regulatory submissions, and patient recruitment.

• Assist in the development and management of the trial budget.
• Plan and maintain integrated trial timelines from study outline through CSR.
• Develop recruitment projections and approve adjustments as needed with the Project Lead.
• Act as counterpart to the CRO Project Lead/Manager.

• Identify and manage trial risks with the CTT.
• Oversee maintenance of CTT issue, action and decision logs.
• Assist in audit preparation and ensure corrective and preventive actions (CAPAs) are implemented.

• Inform overall strategy and the synopsis development in the CDT through cross‑functional teams within clinical operations.
• Proactively engage with internal and external stakeholders (e.g. CTMs, cross‑functional teams, project board, CRO project directors, KOLs, partners) to drive alignment towards project goals.
• Participate in development, monitoring, review, and update of trial/project budgets in collaboration with HoDs and CTMs.
• Drive systems for timely documentation as well as compliance with regulations, SOPs, ICH/GCP, and Code of Business Ethics.
• Guide systemic improvements based on learnings across trials and projects.
• Oversee and participate in activities related to audits and inspections, as well as follow‑up on findings within own projects.
• Lead and participate in cross‑functional working groups/projects/task forces.
• Collaborate with external partners/industry peers and scan the landscape for exploration…