Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
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
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