Executive Director, Early-Stage Clinical Operations

Avetix Bio; Boston (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Avetix Bio seeks a Senior Director, Clinical Operations to provide strategic and operational leadership across early-stage clinical development programs, including clinical pharmacology studies and Phase I/II patient trials. You will partner with portfolio company leadership and cross-functional teams to deliver high-quality trials on time and within budget in a lean biotech incubator setting.

You will build scalable operational capabilities, oversee CRO and vendor performance, mentor staff, and

Qualifications

• 10+ years in clinical operations within biotech/pharma/CROs.
• Experience leading early-stage pharmacology and Phase I/II studies.
• Proven CRO/vendor governance, budget, and quality oversight.

Responsibilities

• Lead clinical operations for multiple early development programs across companies.
• Develop operational strategy aligned with program priorities, including timeline, cost, enrolment, and risk models.
• Serve as a trusted partner to executive leadership and cross-functional teams.
• Study Execution: lead studies from protocol development through closeout, driving global operational strategy and risk mitigation.
• Oversee CRO/vendor lifecycle, budgets, timelines, forecasts, resources, and performance.
• Quality & Continuous Improvement: ensure compliance with ICH-GCP and global regulations while maintaining inspection readiness.
• Drive continuous improvement through scalable processes, SOPs, and best practices.
• Develop and mentor clinical operations staff and external resources.
• Champion innovative approaches to trial execution including digital technologies and AI-enabled analytics.

Skills

Clinical operations leadership

Global trials

CRO/vendor oversight

Budget accountability

ICH-GCP compliance

Regulatory knowledge

Enrollment modeling

Strategic planning

Stakeholder influence

Digital/AI analytics

Job description

Avetix Bio seeks a Senior Director, Clinical Operations to provide strategic and operational leadership across early-stage clinical development programs, including clinical pharmacology studies and Phase I/II patient trials. You will partner with portfolio company leadership and cross-functional teams to deliver high-quality trials on time and within budget in a lean biotech incubator setting.

You will build scalable operational capabilities, oversee CRO and vendor performance, mentor staff, and