Associate Director, Global Trial Lead
Company: Genmab
Job ID: R14705
Category: Development Operations
Location: United States / Global (Remote Option)
Work Model: Remote / Hybrid
Career Level: Associate Director
Job Overview
Genmab is seeking an Associate Director, Global Trial Lead (GTL) to oversee end-to-end clinical trial delivery, from initial study strategy to Clinical Study Report (CSR) completion. The GTL will lead cross-functional Clinical Trial Teams (CTT), manage trial budgets, coordinate internal and external stakeholders, and ensure high-quality execution in alignment with program objectives.
This role serves as a strategic and operational hub, potentially taking on Clinical Trial Manager (CTM) responsibilities when needed, and plays a critical part in global clinical development.
Key Responsibilities
Trial Leadership and Management
Lead cross-functional Clinical Trial Teams, including Medical, Biostatistics, Programming, Data Management, and operational team members such as CTAs, CTMs, and Start-up Specialists.
Assign resources, manage team tasks, and ensure deadlines are met.
Provide regular trial updates, escalate risks, and report to the Development Operations Program Lead (DOPL).
Review and approve key trial documents, protocols, amendments, plans, and manuals.
Oversee vendor selection, contracts, and amendments.
Coordinate country selection and manage responses to IEC/IRB comments.
Maintain trial integrity by ensuring protocol adherence and analyzing data trends.
Collaborate with DOPLs on cross-functional development activities.
Budget and Planning
Assist in the development and management of trial budgets.
Plan integrated trial timelines from study outline through CSR.
Develop recruitment projections and approve adjustments.
Serve as a counterpart to CRO Project Leads/Managers.
Risk Management
Identify and manage trial risks with CTT.
Oversee CTT issue, action, and decision logs.
Support audit preparation and implement CAPAs as needed.
Additional Responsibilities
Contribute to trial strategy and synopsis development through cross-functional teams.
Engage proactively with internal and external stakeholders (CTMs, CROs, KOLs, project boards).
Monitor, review, and update trial/project budgets in collaboration with HoDs and CTMs.
Ensure compliance with regulations, SOPs, ICH/GCP, and Code of Business Ethics.
Lead cross-functional working groups, process improvement initiatives, and knowledge sharing.
Train and mentor teams on emerging clinical trial best practices.
Required Qualifications
Proven experience in a complex, global, and matrixed organization.
Pharmaceutical industry experience with knowledge of ICH/GCP regulations.
Oncology or therapeutic-area-specific drug development experience across various phases.
Demonstrated leadership, mentoring, and matrix management experience.
Advanced knowledge in end-to-end trial planning, execution, and outsourcing/vendor management.
Strong project management, regulatory submission knowledge, and ability to monitor KPIs.
Excellent written and verbal communication, negotiation, and stakeholder management skills.
Ability to proactively identify risks, develop mitigation strategies, and resolve issues.
Experience managing global, multi-regional clinical trials.
Compensation (US-Based Roles)
Salary Range: USD 148,320 – 222,480 annually
Actual salary depends on experience, qualifications, and location. Eligible positions may include discretionary bonuses and long-term incentives.
Employee Benefits
401(k) plan with 100% match on first 6% contributions
Medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and 12 weeks discretionary parental leave
Wellness programs, tuition reimbursement, and Lifestyle Spending Account
Family support programs, financial wellness tools, and emotional well-being resources
Commuter benefits
About You
Passionate about advancing patient care and scientific innovation
Collaborative, generous, and capable of leading diverse teams
Rooted-in-science approach to problem-solving
Able to navigate complexity and innovate in fast-paced environments
Committed to excellence, quality, and team success
About Genmab
Genmab is a global biotechnology company dedicated to transforming the lives of patients through innovative antibody therapeutics. With 25 years of pioneering research in next-generation antibody technology platforms and translational science, Genmab develops breakthrough therapies for oncology and serious diseases. Headquartered in Copenhagen, Denmark, Genmab operates across North America, Europe, and Asia-Pacific.
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