BA/BS in Health Sciences, Life Sciences, or related field; advanced degree preferred
12+ years in pharmaceutical, biotechnology, medical device, or CRO industry
Extensive experience in clinical monitoring and sponsor oversight
Proven track record in leading monitoring oversight programs
Strong knowledge of global clinical trial regulations and ICH-GCP
Experience in CRO governance and vendor management
Demonstrated ability to manage personnel and budgets effectively
Responsibilities
Lead Monitoring Oversight activities across Clinical Operations
Establish governance frameworks and operational plans
Develop monitoring oversight and quality strategies
Set key performance indicators and operational metrics
Drive sponsor oversight programs and governance processes
Oversee monitoring quality review and issue management
Lead inspection and audit readiness activities
Benefits
Competitive pay and stock options
Medical, dental, and vision insurance
100% Paid Parental Leave
Short- and long-term disability coverage
401(k) Company Match with immediate vesting
Generous vacation plan and paid holiday shutdowns
Access to various health and wellness programs
Full Job Description
Description
Reporting to the Senior Director, Monitoring Oversight, Clinical Operations Excellence leadership, or equivalent functional leadership, the Director, Monitoring Oversight is responsible for leading the Monitoring Oversight function across the Clinical Operations organization. This role partners closely with Clinical Operations leadership and cross-functional stakeholders to establish governance frameworks, monitoring oversight programs, CRO oversight standards, and operational processes that ensure effective sponsor oversight across the clinical portfolio.
This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to):
Lead and oversee all Monitoring Oversight activities across the Clinical Operations organization
Establish functional objectives, priorities, governance frameworks, and operational plans aligned with organizational goals
Develop and maintain monitoring oversight, CRO oversight, and monitoring quality strategies across the clinical portfolio
Establish key performance indicators, operational metrics, and reporting frameworks to measure monitoring effectiveness
Drive development and implementation of sponsor oversight programs and governance processes
Establish organizational standards for monitoring quality, oversight execution, and vendor performance management
Oversee monitoring quality review programs and portfolio-level issue management activities
Lead monitoring-related inspection and audit readiness activities
Partner with Clinical Operations leadership to assess and improve study execution effectiveness
Provide executive oversight of CRO monitoring organizations and strategic vendor partners
Establish monitoring escalation pathways and governance structures
Lead implementation and evolution of RBQM surveillance programs
Develop departmental budgets, staffing plans, and resource priorities
Lead organizational initiatives focused on oversight quality and operational excellence
Manage and develop managers, individual contributors, and functional subject matter experts
Support workforce planning, succession planning, and talent development activities
Identify strategic risks impacting monitoring quality and sponsor oversight effectiveness
Serve as a senior leader within Clinical Operations Excellence
Promote a culture of accountability, collaboration, operational excellence, and continuous improvement
Ensure activities are conducted in accordance with company procedures, ICH-GCP guidelines, and applicable regulations
Requirements
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 success building and developing high-performing teams
Proven ability to establish strategy and translate objectives into operational execution
Experience driving organizational change and continuous improvement initiatives
Strong business and operational acumen
Strong attention to detail
Strong organizational and time-management skills
Strong written, verbal, and interpersonal communication skills
Strong analytical, critical-thinking, and problem-solving abilities
Demonstrated leadership and stakeholder-management capabilities
Ability to influence senior leadership and cross-functional decision making
Strong commitment to quality, compliance, and operational excellence
Demonstrated professionalism, integrity, accountability, and sound judgment
Commitment to continuous improvement and organizational effectiveness
Ability to travel 50%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
100% Paid Parental Leave
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
About Viridian Therapeutics
Viridian Therapeutics is a biotechnology company that develops gene therapies for inherited diseases. The company's lead product candidate, VRDN-001, is a gene therapy for Friedreich's ataxia, a rare genetic disease that causes progressive damage to the nervous system. Viridian Therapeutics was founded in 2018 and is headquartered in Cambridge, Massachusetts.
