Remote Global Phase III Oncology Operations Director

Eliassen Group; United States; Remote; USD 207,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k with company matching

Life insurance

Job summary

Eliassen Group is seeking a Director of Clinical Operations to lead a large global Phase III breast cancer study. The role drives startup, site activation, CRO/vendor oversight, and cross-functional coordination across ~30 countries and ~400 sites, advancing milestones toward database lock and regulatory submission.

This position reports to the VP of Clinical Operations and operates in a fast-moving environment leveraging established infrastructure.

Qualifications

• 10+ years of progressive Clinical Operations or clinical research with significant sponsor-level leadership.
• Oncology experience required; breast cancer experience strongly preferred.
• Demonstrated leadership of large global Phase III studies across multiple regions.
• Direct experience leading a global Phase III study through late-stage execution and NDA/BLA submission.
• Deep experience with study start-up and global site activation for complex late-stage trials.
• Extensive experience managing and overseeing global CROs and vendors.

Responsibilities

• Lead operational execution of a global Phase III breast cancer study from start-up through regulatory milestones.
• Drive study start-up across ~30 countries and ~400 sites with tracked and achieved timelines.
• Provide sponsor oversight of CROs and vendors with clear expectations, deliverables, accountability, and escalation.
• Hold CROs accountable for contractual performance, milestones, quality, enrollment, and timelines.
• Identify risks and bottlenecks early and implement mitigation strategies.
• Coordinate cross-functional activities with Clinical Development, Data Management, Biostatistics, Regulatory, Safety, and Quality.
• Establish and monitor study-level metrics, milestones, risks, dependencies, and vendor performance.
• Oversee global site activation and start-up strategy.
• Drive operational decision-making with urgency appropriate for a pivotal program.
• Maintain inspection-readiness and documentation standards.
• Manage CRO and vendor escalation and intervene when performance or timelines are at risk.
• Provide concise status and risk reporting to Clinical Operations and senior leadership.
• Advance the study toward database lock and NDA/BLA submission.
• Operate effectively in a fast-moving biotech environment with high accountability.

Skills

Leadership

Global trials

CRO oversight

Cross-functional leadership

Project management

Risk management

ICH/GCP knowledge

Job description

Eliassen Group is seeking a Director of Clinical Operations to lead a large global Phase III breast cancer study. The role drives startup, site activation, CRO/vendor oversight, and cross-functional coordination across ~30 countries and ~400 sites, advancing milestones toward database lock and regulatory submission.

This position reports to the VP of Clinical Operations and operates in a fast-moving environment leveraging established infrastructure.