Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)
GenmabThe Director, Strategic Clinical Vendor Oversight and Relationship Lead is responsible for advancing and operationalizing Genmab's clinical outsourcing and vendor governance model across the development portfolio. In close partnership with the Head of Function, this role drives portfolio‐level CRO/clinical vendor performance management across all Clinical Trial Delivery, operating model refinement
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, and process innovation initiatives that enhance scalability, predictability, and quality of trial delivery.
Responsibilities
Operational Oversight
• Provide portfolio-level oversight of outsourced Phase I–III clinical trials, identifying systemic performance trends and execution risks across programs.
• Ensure vendor delivery aligns with strategic portfolio timelines, budget expectations, and quality standards.
• Lead resolution of complex or high-impact operational issues, serving as senior escalation point within established governance pathways.
• Drive consistent application of oversight standards and performance expectations across study teams.
Vendor Management
• Lead operational performance oversight of assigned clinical vendor(s), ensuring effective implementation of established governance frameworks and partnership models.
• Represent the function in Portfolio Operational Committee meetings and contribute to executive-level Steering Committee discussions in collaboration with the Head of Function as necessary.
• Oversee performance analytics and trend reporting to enable proactive risk management and continuous improvement.
• Partner with Procurement to strengthen performance-based oversight and cost transparency.
Process Optimization
• Lead department initiatives to refine and scale the outsourcing operating model in alignment with portfolio growth.
• Identify systemic inefficiencies across trial start‐up, execution, and closeout and implement standardized best practices to reduce variability.
• Drive development and adoption of governance playbooks, oversight dashboards, and performance metrics.
• Partner with Digital and innovation initiatives to modernize vendor oversight through data‐driven tools and automation.
Team Support and Collaboration
• Serve as advisor and escalation resource to Development Operational Program Leaders, Global Trial Leaders, Clinical Trial Managers, and cross‐functional leaders on vendor oversight strategy and execution.
• Establish training frameworks and capability‐building initiatives to elevate outsourcing and governance competencies across the organization.
• Foster a culture of accountability, partnership, and continuous improvement.
Cross‐functional Partnership
• Partner with key stakeholders within Clinical Trial Delivery, Clinical Strategy, Regulatory Affairs, Quality, Finance, and Procurement to ensure outsourcing practices support broader development objectives.
• Provide strategic insight into vendor capacity, performance risks, and execution readiness to inform portfolio planning.
• Strengthen collaboration with vendors to promote transparency, proactive issue management, and long‐term partnership effectiveness.
Compliance and Governance
• Ensure outsourced trial activities align with ICH‐GCP, global regulatory requirements, and Genmab quality systems.
• Oversee inspection‐readiness for vendor‐managed activities and support audit preparedness across programs.
• Monitor industry and regulatory trends and recommend enhancements to governance practices accordingly.
Qualifications
Education
• Bachelor's degree required; advanced degree preferred.
Experience
• 8–10+ years of experience in clinical operations, vendor oversight, or outsourcing management within biotech/pharma.
• Experience working in clinical trial management and execution.
• Familiarity with portfolio‐level operational standards.
• Solid understanding of ICH‐GCP and global regulatory requirements.
Compensation For US based candidates, the proposed salary band for this position is $193,280.00—$289,920.00.
Benefits
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