DescriptionReporting to the Chief Medical Officer, the Vice President, Clinical Operations will lead and oversee all aspects of Clinical Operations at Viridian, with accountability for the successful execution of global clinical trials across the company's pipeline. This role will set and execute the Clinical Operations strategy, ensuring high-quality, efficient trial delivery aligned with asset-level development plans, timelines, and budgets. The VP, Clinical Operations will build, lead, and develop a high-performing Clinical Operations organization; establish robust operational processes and CRO/vendor oversight models; and ensure inspection readiness and regulatory compliance. As a key cross-functional leader, this individual will partner closely with Clinical Development, Regulatory, Biometrics, Quality, and other internal stakeholders, while fostering strong, collaborative relationships with external vendors to support Viridian's continued growth and progression toward late-stage development and commercialization.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):Clinical Operations Leadership & Strategy- Provide enterprise-level leadership for global Clinical Operations across all phases of development, from first-in-human through registrational and post-approval studies.
- Develop and execute the clinical operations strategy aligned with asset-level development plans, corporate objectives, and long-term pipeline priorities.
- Serve as a key member of the clinical development leadership team, contributing to program governance, portfolio planning, and development decision-making.
- Ensure the consistent, high-quality execution of global clinical trials, including oversight of timelines, milestones, enrollment, budgets, quality, and risk management.
- Partner closely with Clinical Development, Regulatory, Pharmacovigilance, Biometrics, Medical Affairs, Quality, and Program Management to ensure seamless trial execution and data delivery.
- Provide executive oversight of trial start-up, enrollment acceleration strategies, site management, and close-out activities across all programs.
Vendor & CRO Management- Establish and lead the CRO and vendor strategy for Clinical Operations, including selection, governance models, performance metrics, and issue escalation.
- Oversee outsourcing activities to ensure vendors deliver against scope, quality, timelines, and cost expectations while maintaining strong partnership behaviors.
- Drive continuous improvement in vendor oversight, operational efficiency, and cost-effectiveness across the clinical portfolio.
Quality, Compliance & Inspection Readiness- Ensure all clinical operations activities are conducted in compliance with global regulatory requirements, GCP, internal SOPs, and quality standards.
- Oversee inspection readiness efforts and lead responses to regulatory inspections, audits, and findings related to clinical operations.
- Partner with Quality and Regulatory teams to proactively assess operational risk and implement mitigation strategies.
Organizational Leadership & Team Development- Build, lead, and mentor a high-performing Clinical Operations organization, including hiring, development, performance management, and succession planning.
- Foster a culture of accountability, collaboration, and continuous improvement across the Clinical Operations team.
- Support organizational scaling by designing fit-for-purpose operating models, capabilities, and processes as the pipeline evolves.
Operational Excellence & Process Improvement- Drive the optimization of clinical operations processes, systems, and KPIs to improve speed, quality, and scalability of trial execution.
- Champion the adoption of innovative approaches, technologies, and data-driven insights to enhance operational performance.
- Establish and track operational metrics to enable transparent reporting to executive leadership and governance bodies.
Cross-Functional & External Representation- Act as the primary Clinical Operations representative in cross-functional forums, governance committees, and asset team meetings.
- Represent Viridian in external interactions with investigators, CRO partners, industry forums, and regulatory agencies as needed.
- Contribute to the development of scientific and operational content for investigator meetings, internal reviews, and leadership presentations.
Requirements- 18+ years of progressive experience in Clinical Operations within the biopharmaceutical industry, including leadership responsibility across multiple phases of global clinical development.
- Demonstrated success leading end-to-end clinical trial execution from early clinical development through registrational studies.
- Proven experience operating at the leadership level, with accountability for complex programs, cross-functional alignment, and enterprise decision-making.
- Extensive experience managing CROs and external vendors, including selection, governance, performance oversight, and issue escalation.
- Strong background supporting inspection readiness, regulatory interactions, and audit responses related to clinical operations.
- Ability to travel depending on project needs (~10-15%)
- 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
