Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)
Genmab
June 25, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Director, Strategic Clinical Vendor Oversight and Relationship Lead
Responsibilities
Operational Oversight:
- Provide portfolio-level oversight of outsourced Phase I–III clinical trials; identify systemic performance trends and execution risks.
- Ensure vendor delivery aligns with strategic timelines, budget expectations, and quality standards.
- Lead resolution of complex/high-impact operational issues as senior escalation point.
- Drive consistent application of oversight standards and performance expectations across study teams.
Vendor Management:
- Lead operational performance oversight of assigned clinical vendor(s).
- Represent the function in Portfolio Operational Committee meetings and contribute to Steering Committee discussions as needed.
- Oversee performance analytics and trend reporting for proactive risk management and continuous improvement.
- Partner with Procurement to strengthen performance-based oversight and cost transparency.
Process Optimization:
- Refine and scale the outsourcing operating model in alignment with portfolio growth.
- Identify systemic inefficiencies across trial start-up, execution, and closeout; implement standardized best practices.
- Drive adoption of governance playbooks, oversight dashboards, and performance metrics.
- Partner with Digital/innovation to modernize vendor oversight via data-driven tools and automation.
Team support and Collaboration:
- Advise/escalate to Development Operational Program Leaders, Global Trial Leaders, Clinical Trial Managers, and cross-functional leaders.
- Establish training and capability-building for outsourcing and governance.
- Foster accountability, partnership, and continuous improvement.
Cross-functional Partnership & Compliance/Governance:
- Partner with Clinical Trial Delivery, Clinical Strategy, Regulatory Affairs, Quality, Finance, and Procurement.
- Ensure outsourced activities align with ICH-GCP, global regulatory requirements, and quality systems; support inspection/audit readiness.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- 8–10+ years in clinical operations, vendor oversight, or outsourcing management (biotech/pharma).
- Experience in clinical trial management and execution.
- Familiarity with portfolio-level operational standards.
- Solid understanding of ICH-GCP and global regulatory requirements.
Benefits (US first-year full-time regular employees)
- 401(k): 100% match on first 6% contributions.
- Health benefits (2 medical plans incl. HDHP with HSA), dental, vision.
- Voluntary plans: critical illness, accident, hospital indemnity.
- Paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave.
- Child/adult backup care, family support programs, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions
- Apply via the Genmab website (Job Applicant Privacy Notice referenced for US applicants).
Responsibilities
Operational Oversight:
- Provide portfolio-level oversight of outsourced Phase I–III clinical trials; identify systemic performance trends and execution risks.
- Ensure vendor delivery aligns with strategic timelines, budget expectations, and quality standards.
- Lead resolution of complex/high-impact operational issues as senior escalation point.
- Drive consistent application of oversight standards and performance expectations across study teams.
Vendor Management:
- Lead operational performance oversight of assigned clinical vendor(s).
- Represent the function in Portfolio Operational Committee meetings and contribute to Steering Committee discussions as needed.
- Oversee performance analytics and trend reporting for proactive risk management and continuous improvement.
- Partner with Procurement to strengthen performance-based oversight and cost transparency.
Process Optimization:
- Refine and scale the outsourcing operating model in alignment with portfolio growth.
- Identify systemic inefficiencies across trial start-up, execution, and closeout; implement standardized best practices.
- Drive adoption of governance playbooks, oversight dashboards, and performance metrics.
- Partner with Digital/innovation to modernize vendor oversight via data-driven tools and automation.
Team support and Collaboration:
- Advise/escalate to Development Operational Program Leaders, Global Trial Leaders, Clinical Trial Managers, and cross-functional leaders.
- Establish training and capability-building for outsourcing and governance.
- Foster accountability, partnership, and continuous improvement.
Cross-functional Partnership & Compliance/Governance:
- Partner with Clinical Trial Delivery, Clinical Strategy, Regulatory Affairs, Quality, Finance, and Procurement.
- Ensure outsourced activities align with ICH-GCP, global regulatory requirements, and quality systems; support inspection/audit readiness.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- 8–10+ years in clinical operations, vendor oversight, or outsourcing management (biotech/pharma).
- Experience in clinical trial management and execution.
- Familiarity with portfolio-level operational standards.
- Solid understanding of ICH-GCP and global regulatory requirements.
Benefits (US first-year full-time regular employees)
- 401(k): 100% match on first 6% contributions.
- Health benefits (2 medical plans incl. HDHP with HSA), dental, vision.
- Voluntary plans: critical illness, accident, hospital indemnity.
- Paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave.
- Child/adult backup care, family support programs, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions
- Apply via the Genmab website (Job Applicant Privacy Notice referenced for US applicants).