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!
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.
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.
- 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.
- 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
o Regulatory submission knowledge
o Develop and monitor key performance metrics
o Excellent written and verbal communication skills
o Excellent negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
o Strong trial planning and budget management skills.
o Strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle
o Ability to proactively identify risks, develop mitigation strategies, and resolve issues effectively.
o Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations.
o 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.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the contract.
