DescriptionReporting to the VP, Clinical Operations, the Director, Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed upon timelines and budgets. This role reflects the knowledge, experience, skill levels and capacity to manage complex studies or programs.
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):- Lead the execution of one or more global clinical programs, ensuring studies are delivered on time, within budget, and in compliance with GCP, regulatory requirements, and company SOPs
- Provide operational leadership for cross-functional study teams and serve as one of the lead Clinical Operations representative for assigned programs
- Oversee CROs and vendors, including selection, governance, performance management, and issue escalation
- Develop and maintain study timelines, budgets, forecasts, and risk mitigation plans to support successful program execution
- Partner closely with Clinical Development, Regulatory, Biometrics, Medical Affairs, Quality, and other stakeholders to ensure alignment across development activities
- Drive patient recruitment, site engagement, and trial execution strategies to support enrollment and study milestones
- Support inspection readiness and ensure clinical trial activities meet applicable regulatory and quality standards
- Mentor and develop Clinical Operations team members while fostering a culture of accountability, collaboration, and continuous improvement
- Contribute to the enhancement of Clinical Operations processes, systems, metrics, and operational best practices to support organizational growth
- Provide regular updates on program status, risks, and key milestones to senior leadership
Requirements- BS/BA in Life Sciences, Health Sciences, or related field; advanced degree preferred
- 12+ years of Clinical Operations experience within biotech, pharma, or medical device organizations, including management of global clinical trials
- 5+ years of people leadership experience
- Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
- Proven experience overseeing CROs, vendors, study budgets, and timelines
- Experience leading cross-functional teams and driving study execution from startup through closeout
- Demonstrated ability to identify risks, solve complex operational challenges, and deliver results in a fast-paced environment
- Excellent communication, collaboration, and organizational skills
- Rare disease, immunology, and/or ophthalmology experience preferred
- Experience supporting regulatory inspections and audit readiness preferred
- Detail oriented with excellent organizational skills
- Ability to effectively manage multiple tasks and competing priorities
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 20%
- 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
