Global 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

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.