Director, Monitoring Oversight

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

• Location 221 CRESCENT ST STE 103A,Waltham, MA, 02453-3425,United States
• Base Pay $200,000.00 - $245,000.00 / Year
• Job Category Clinical Operations
• Employee Type FT Exempt
• Required Degree 4 Year Degree
• Travel 5%
• Manage Others No

At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases, and we are getting closer to achieving this goal every day.

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
• 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

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.