Associate Director, Global Trial Lead

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 Global Trial Lead (GTL) is accountable 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 GTL serves as the main coordinator for the Trial Team and may take on Clinical Trial Manager (CTM) responsibilities if no CTM is assigned.

This is an office-based hybrid position with the expectation to be onsite at least 60% of your time (or more), to foster collaboration and team engagement.

Roles & Responsibilities

Trial Leadership and Management

• 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).

• Manages 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 escalate issues as needed.

• Execute strategies for drug supply, regulatory submissions, and patient recruitment.

Budget and Planning

• 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.

Risk Management

• 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.

• Act as Subject Matter Expert (SME) for processes within Clinical Operations

Requirements

• Required experience working in a complex, global and matrixed organization

• Required pharmaceutical industry experience with knowledge of ICH/GCP Regulations

• Required oncology or TA specific drug development experience and various phases of development

• Required matrix leadership experience (ability to lead without authority)

• Required experience mentoring others

• Proven leadership experience with a strong focus on people management and developing others preferred

• Expected to have advanced knowledge in:

• End-to-end trial planning and execution

• Outsourcing and vendor management.

• Oncology preferred

Expected to be proficient in:

• Project management skills and…