Director, Monitoring Oversight — Clinical Operations Excellence

Viridian Therapeutics; Waltham (MA); Hybrid; USD 200,000 - 245,000; Full time

Benefits offered by this job

Competitive pay

Stock options for all employees

Medical, dental, and vision insurance

401(k) Company Match with immediate v

Job summary

Viridian Therapeutics, Inc. seeks a Director of Monitoring Oversight to lead the Monitoring Oversight function across Clinical Operations. Hybrid/remote options with Waltham HQ involvement; travel 50% as needed.

Reporting to senior leadership, you will establish governance, oversight programs, and vendor management to ensure sponsor oversight across the clinical portfolio. Strong leadership and regulatory knowledge are essential.

Qualifications

• BA/BS degree in Health Sciences, Life Sciences, or related discipline required; advanced degree preferred.
• Minimum of 12 years of experience within the pharmaceutical, biotechnology, medical device, and/or CRO industry.
• Extensive experience in clinical monitoring, sponsor oversight, clinical operations, or quality management functions.
• Demonstrated success leading monitoring oversight programs across multiple studies, programs, and portfolios.
• Strong knowledge of global clinical trial regulations, inspection-readiness expectations, and ICH-GCP requirements.
• Experience leading CRO governance, vendor management, and performance oversight activities.
• Experience developing functional objectives, strategic priorities, and operational plans.
• Experience managing personnel, vendors, budgets, and strategic initiatives.
• Demonstrated leadership and stakeholder-management capabilities.
• Ability to travel 50%.

Responsibilities

• Lead and oversee Monitoring Oversight activities across the Clinical Operations organization.
• Establish objectives, priorities, governance frameworks, and operational plans.
• Develop monitoring oversight, CRO oversight, and monitoring quality strategies.
• Establish KPIs, metrics, and reporting for monitoring effectiveness.
• Drive sponsor oversight programs and governance processes.
• Set organizational standards for monitoring quality and vendor performance.
• Oversee monitoring quality review programs and portfolio-level issues.
• Lead inspection and audit readiness activities.
• Partner with leadership to improve study execution.
• Provide executive oversight of CRO monitoring and vendors.

Skills

Leadership

Stakeholder management

Strategic thinking

Communication

Analytical thinking

Problem-solving

Education

BA/BS degree in Health Sciences, Life Sciences, or related discipline

Advanced degree preferred

Job description

Viridian Therapeutics, Inc. seeks a Director of Monitoring Oversight to lead the Monitoring Oversight function across Clinical Operations. Hybrid/remote options with Waltham HQ involvement; travel 50% as needed.

Reporting to senior leadership, you will establish governance, oversight programs, and vendor management to ensure sponsor oversight across the clinical portfolio. Strong leadership and regulatory knowledge are essential.