Vice President – Clinical Operations

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

📋 Description

• Provide leadership and oversight for extensive global clinical development programs or multiple Phase 1–2 studies from initiation through database lock.

• Ensure that clinical trials adhere to timelines, meet quality standards, align with budget constraints, and fulfill corporate goals.

• Guide Clinical Operations teams in identifying potential risks, formulating mitigation strategies, and addressing operational challenges.

• Maintain uniform execution of operational strategies and readiness for inspections across various studies.

• Enhance study performance through operational metrics and a focus on continuous improvement.

• Lead, mentor, and foster the development of Clinical Operations leaders.

• Collaborate with Clinical Science, Regulatory Affairs, Data Sciences/Medical, Clinical Compliance, Quality Assurance, Pharmacovigilance, and Technical Operations teams.

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

• Provide executive oversight of CROs and strategic vendors.

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

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

• Create scalable operational processes, governance structures, KPIs, and performance analytics to enhance execution efficiency and support informed decision-making.

⛳️ Requirements

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

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

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

• Experience participating in regulatory authority inspections in support of global clinical development programs.

• More than 6 years of leadership experience, including managing senior Clinical Operations leaders.

• Proven track record of overseeing large global programs or multiple concurrent studies with considerable operational complexity.

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

• Established ability to guide multiple Clinical Operations trial teams across concurrent programs.

• Capability to design scalable processes that facilitate organizational growth.

• Experience utilizing metrics, dashboards, and operational analytics to enhance performance and decision-making.

• History of implementing process improvements.

• Experience in leading global CROs and strategic vendor partnerships.

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

• Experience in ophthalmology (retina) clinical development is strongly preferred.

🏝️ Benefits

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

• Flexible remote work arrangement.

• Commitment to equal employment opportunities.

• 5% travel requirement.