Director, Clinical Operations

Kids for the Future; Waltham (MA); Hybrid; USD 200,000 - 245,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

401(k) matching and stock purchase

Job summary

Viridian Therapeutics, based in Waltham, MA, seeks an accomplished Director of Clinical Operations to lead global programs, manage cross-functional teams, and drive trial execution on time and within budget. This role requires deep knowledge of GCP, regulatory standards, and vendor management.

You will mentor teams, collaborate with Regulatory, Biostatistics, Medical Affairs, and Quality, and ensure inspection readiness while advancing program milestones in a fast-paced environment.

Qualifications

• BS/BA in Life Sciences, Health Sciences, or related field required; advanced degree preferred.
• 12+ years of Clinical Operations experience in biotech/pharma/medical devices, including global trials.
• 5+ years of people leadership experience.
• Strong knowledge of ICH-GCP, FDA, EMA and global regulatory requirements.
• Experience overseeing CROs, vendors, budgets, and timelines.

Responsibilities

• Lead execution of one or more global clinical programs delivering studies on time and within budget.
• Provide operational leadership for cross-functional study teams.
• Oversee CROs and vendors, including selection, governance, and issue escalation.
• Develop and maintain study timelines, budgets, forecasts, and risk mitigation plans.
• Partner with Clinical Development, Regulatory, Biostatistics, Medical Affairs, Quality, and other stakeholders for alignment.
• Drive patient recruitment, site engagement, and trial execution strategies.
• Support inspection readiness and regulatory compliance.
• Mentor Clinical Operations team members and foster accountability and collaboration.
• Contribute to improvements of processes, systems, metrics, and best practices.
• Provide regular updates on program status to senior leadership.

Skills

GCP knowledge

Regulatory knowledge

Leadership

Cross-functional collaboration

Budgeting

Vendor management

Education

BS/BA in Life Sciences or related field

Advanced degree preferred

Tools

MS Office

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
• Required Degree 4 Year Degree
• Travel 20%

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 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
• 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.