Vice President – Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and execute strategic operations for one or more complex global clinical programs within the ophthalmology sector and/or broader portfolio.

• Plan and conduct clinical trials, ensuring high-quality, inspection-ready data is delivered on time and within budget.

• Lead Clinical Operations teams responsible for the execution of studies.

• Collaborate with Clinical Science, Medical, Regulatory, Data Sciences, Clinical Compliance, Quality, Business Operations, Pharmacovigilance, and Technical Operations.

• Identify and address operational risks, enhance trial performance, and promote executional excellence throughout Phase 1–3 clinical development.

• Mentor and develop leaders within Clinical Operations.

• Represent Clinical Operations on cross-functional program teams and escalate critical issues to executive leadership as necessary.

• Provide executive oversight for CROs and strategic vendors.

• Manage study budgets, forecasts, change orders, and resource planning.

• Ensure inspection readiness and compliance with GCP, SOPs, regulatory standards, and quality benchmarks.

• Create scalable operational processes, governance frameworks, KPIs, and operational metrics.

• Leverage data and performance analytics to inform decision-making, resource allocation, and study execution.

• Foster standardization, accountability, and ongoing process improvement.

⛳️ Requirements

• Bachelor's degree in a scientific, business, or health-related field.

• Over 15 years of experience in Clinical Operations within biotechnology or pharmaceutical development.

• Extensive experience leading global Phase 1-2 and/or Phase 3 clinical trials.

• Proven experience participating in regulatory authority inspections that support global clinical development programs.

• A minimum of 6 years in people leadership, including managing senior Clinical Operations leaders.

• Track record of successfully overseeing large global programs or multiple concurrent studies with significant operational complexity.

• Demonstrated success in leading complex global Phase 1-3 clinical trials.

• Proven capability to lead multiple Clinical Operations trial teams across concurrent programs.

• Strong systems thinking and the ability to design scalable processes that support organizational growth.

• Experience utilizing metrics, dashboards, operational analytics, and performance data to guide decisions and outcomes.

• Background in implementing process improvements that enhance efficiency, quality, and predictability of execution.

• Experience in leading global CROs and managing strategic vendor partnerships.

• Exceptional leadership, coaching, and organizational development abilities.

• Ability to influence cross-functional teams without direct authority.

• Executive presence, clear communication skills, and strong decision-making capabilities.

• In-depth knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.

• Clinical development experience in ophthalmology (particularly retina) is highly preferred.

🏝️ Benefits

• Base salary compensation range of $310,000 - $365,000.

• Travel requirement: 5%.