Director (Health Lead)

1 week geleden


Utrecht, Nederland Genmab Voltijd

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.
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.

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.
Define and manage CTT goals in collaboration with team members.
Oversee vendor selection and manage trial-related contracts and amendments.
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.
Budget and Planning
Assist in the development and management of the trial budget.
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.
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).
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.
Project management skills and knowledge of tools and processes.
Strong trial planning and budget management skills.
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.Inform overall strategy and the synopsis development in the CDT through cross-functional teams within clinical operations
CTMs, cross-functional teams, project board, CRO project directors, KOLs, partners) to drive alignment towards project goals
Lead and participate in cross-functional working groups/projects/task forces
Collaborate with external partners/industry peers and scan the landscape for exploration and adoption of cutting-edge methods to address internal challenges/needs
Train and mentor teams on emerging clinical trial best practices
When You Join Genmab, You’re Joining a Culture That Supports Your Physical, Financial, Social, And Emotional Wellness. Within The First Year, Regular Full-time U.Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
~ Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
~ Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
~ Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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
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.
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.
Genmab is committed to protecting your personal data and privacy. Xnkfpon Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ( ).
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 fixed-term employment contract.


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