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.
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.
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 you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.