Associate Director, Global Trial Lead
Associate Director, Global Trial Lead
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1 Vacancy
Job Description
At Genmab we are dedicated to building extranotordinary 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 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.
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Required Experience:
Exec
Employment Type
Full-Time
