Hybrid Associate Director, Global Trial Lead

at Genmab

• Job title: Associate Director, Global Trial Lead
• Job type: Full Time
• Experience level: Senior
• Salary: $148,320 - $222,480 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Princeton, United States

About the role

• Associate Director Global Trial Lead managing cross-functional clinical trials at Genmab. Leading efforts in clinical strategy, budget management, and stakeholder collaboration through various development phases.

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.
• 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.

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 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.
• 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