Vice President – Clinical Operations

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Develop and implement a comprehensive global clinical operations strategy that aligns with growth goals and integrated service delivery.

• Lead and expand global clinical operations teams.

• Foster operational excellence across clinical programs, emphasizing quality, speed, and consistency.

• Manage the entire lifecycle of clinical trials, from study initiation to closeout.

• Ensure timely delivery within the defined scope and budget, adhering to ICH-GCP, FDA, EMA, and other relevant regulations.

• Establish and track KPIs, performance metrics, and dashboards.

• Enhance global resource planning and utilization in collaboration with Finance and HR.

• Incorporate quality-by-design principles and address audit findings, CAPAs, and continuous improvement initiatives.

• Ensure the consistent implementation and ongoing evolution of SOPs, processes, and governance frameworks.

• Act as the executive point of contact for major clients.

• Collaborate with Business Development and Commercial teams on proposals, bid defenses, and client presentations.

• Integrate eClinical and other technological solutions into clinical operations.

• Advocate for AI-driven tools and analytics for trial execution, forecasting, risk identification, and decision-making.

• Lead cross-functional collaboration across Medical Affairs, Regulatory, Data Management, Biostatistics, Product Management, and Quality.

• Build and nurture a high-performing leadership team.

• Create career pathways, training frameworks, and succession plans.

• Oversee clinical operations financial performance, including budgets, forecasting, revenue realization, and margin optimization.

• Contribute to initiatives for operational scaling, global expansion, and M&A integration.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related discipline.

• 15+ years of progressive leadership experience in clinical operations within a CRO, biotech, or pharmaceutical setting.

• Proven experience leading global, multi-functional clinical operations teams across various regions.

• Demonstrated success in delivering complex clinical programs at scale.

• In-depth knowledge of regulatory requirements and industry best practices.

• Experience in integrating technology and/or eClinical platforms into clinical delivery models.

• Strong financial acumen, including knowledge of budgets, forecasting, and operational P&L drivers.

• Experience supporting business development activities, including proposals, bid defenses, and client relationship management.

• Outstanding leadership, communication, and stakeholder management skills.

• Ability to function effectively in a high-growth, fast-paced, and dynamic organization.

• Willingness to work shifts as necessary.

• Capability to work standard hours of 40 hours per week, Monday–Friday, with additional hours as required.

🏝️ Benefits

• Competitive salary.

• Paid time off.

• Healthcare benefits.

• Retirement benefits.