Responsibilities
- Provide portfolio-level oversight of outsourced Phase IโIII clinical trials; identify systemic performance trends and execution risks.
- Ensure vendor delivery aligns with portfolio 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.
Vendor Management
- Lead operational performance oversight of assigned clinical vendor(s) and ensure effective governance/partnership implementation.
- Represent the function in Portfolio Operational Committee; 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 with portfolio growth.
- Identify and standardize best practices across trial start-up, execution, and closeout to reduce variability.
- Drive adoption of governance playbooks, oversight dashboards, and performance metrics.
- Modernize vendor oversight with data-driven tools and automation.
Qualifications
- Bachelorโs degree required; advanced degree preferred.
- 8โ10+ 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)
- 401(k) 100% match on first 6%; medical/dental/vision; paid vacation/sick/holidays; 12 weeks discretionary paid parental leave; commuter, tuition reimbursement, Lifestyle Spending Account; backup care and wellness resources.
Application instructions
- Apply to the role through Genmabโs careers site (Job Applicant Privacy Notice referenced).