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!

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 Experience Mentoring Others.
• Required matrix leadership experience (ability to lead without authority).
• Proven leadership experience with a strong focus on people management and developing others preferred
• Expected To Have Advanced Knowledge InEnd-to-end trial planning and execution.
• Outsourcing and vendor management.
• Expected To Be Proficient In:
• Project management skills and knowledge of tools and processes.
• Regulatory submission knowledge.
• Develop and monitor key performance metrics.
• Excellent written and verbal communication skills.
• Excellent negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization.
• Strong trial planning and budget management skills.
• Strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle.
• Ability to proactively identify risks, develop mitigation strategies, and resolve issues effectively.
• Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations.
• Stakeholder management skills.
• Learning and developing strong program planning and budget management skills.
• Developing ability to drive working groups and lead process improvements, champion more efficient and effective methods/processes.

THE ROLE

As 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.

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.