Vice President Clinical Operations
Behavioral Health Market Context
Apply Nowvia LinkedIn
Qualifications
- •Travel up to 30% required
- •Bachelor’s degree in life sciences or related field (required)
- •15+ years of progressive experience in Clinical Operations within biotech or pharmaceutical companies
- •7 years of leadership experience, including building and leading teams
- •Demonstrated success delivering global clinical trials across multiple phases
- •Deep knowledge of global clinical development and regulatory requirements (FDA, EMA, ICH/GCP)
- •COMPETENCIES/CORE SKILLS
- •Strong strategic thinking with hands-on execution capability
- •Proven ability to build infrastructure, processes, and high-performing teams
- •Expertise in vendor strategy, governance, and performance management
- •Excellent communication, leadership, and stakeholder management skills
- •Ability to thrive in a fast-paced, evolving biotech environment
- •Applicants must have legal authorization to work in the United States
- •In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire
- •11 more items(s)
Responsibilities
- •Fortvita is seeking a strategic and execution-focused Vice President of Clinical Operations to build, lead, and scale a predominantly in-house clinical operations model
- •This leader will be responsible for the end-to-end delivery of global clinical trials, minimizing reliance on full-service CROs and instead leveraging a hybrid model of internal capabilities supplemented by functional vendors
- •The VP will establish operational infrastructure, develop internal capabilities, and ensure trials are executed with speed, quality, and cost-efficiency
- •This role requires a hands-on leader who thrives in a fast-paced biotech environment and has successfully implemented or operated within an in-house or CRO-lite clinical model
- •Define and execute the Clinical Operations strategy aligned with a lean, in-house execution model
- •Build, mentor, and lead a high-performing internal Clinical Operations team
- •Establish scalable infrastructure, processes, and systems to support global clinical development
- •Serve as a key member of the Development leadership team, contributing to overall portfolio strategy
- •Clinical Trial Execution
- •Oversee the end-to-end execution of global clinical trials (Phase I–III) in compliance with ICH/GCP, FDA, EMA, and global regulations
- •Ensure studies are delivered on time, on budget, and with high quality
- •Drive operational excellence across study startup, conduct, and closeout activities
- •In-House Model Implementation
- •Design and operationalize an in-house clinical trial execution framework, reducing dependency on full-service CROs
- •Determine optimal functional outsourcing strategy (e.g., data management, monitoring, biometrics)
- •Build internal capabilities across study management, vendor oversight, site management, and trial execution
- •Implement tools, systems, and KPIs to support internal delivery
- •Vendor & Partner Management
- •Oversee selection and management of functional service providers and specialty vendors
- •Negotiate contracts, scopes of work, and budgets aligned with a non-CRO-led model
- •Ensure vendor performance through clear metrics, governance, and accountability
- •Cross-Functional Collaboration
- •Partner with Clinical Development, Regulatory, Biometrics, CMC, and other functions to ensure seamless study execution
- •Provide operational input into protocols, study design, and development plans
- •Lead risk identification and mitigation planning across programs
- •Establish and maintain SOPs, work instructions, and best practices
- •Drive inspection readiness and ensure compliance with global regulatory requirements
- •Implement risk-based quality management approaches
- •Operational Excellence
- •Develop and track KPIs, metrics, and dashboards for study and team performance
- •Drive continuous improvement initiatives across Clinical Operations
- •Ensure effective communication of study status, risks, and mitigation plans to executive leadership
- •Other duties as assigned
- •30 more items(s)
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