Genmab · 1 day ago
Associate Director, Global Trial Lead
Princeton, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$148K/yr - $222K/yrGenmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics. The Associate Director, Global Trial Lead is responsible for the end-to-end delivery of clinical trials, leading cross-functional teams, managing budgets, and ensuring high-quality standards throughout the trial process.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
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
Inform overall strategy and the synopsis development in the CDT through cross-functional teams within clinical operations
Proactively engage with internal and external stakeholders (e.g. CTMs, cross-functional teams, project board, CRO project directors, KOLs, partners) to drive alignment towards project goals
Participate development, monitoring, review, and update of trial/project budgets in collaboration with HoDs and CTMs
Drive systems for timely documentation as well as compliance with regulations, SOPs, ICH/GCP, and Code of Business Ethics
Guide systemic improvements based on learnings across trials and projects
Oversee and participate in activities related to audits and inspections, as well as follow-up on findings within own projects
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
Qualification
Required
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 In End-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
Preferred
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
Benefits
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: 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
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
Founded in 1999
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
2026-01-08
Company data provided by crunchbase