Director, Clinical Operations

Xtalks; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive pay and stock options for

Medical, dental, and vision insurance

100% Paid Parental Leave

Disability coverage

401(k) Company Match with immediate v

Job summary

Viridian Therapeutics, Inc. seeks a Director, Clinical Operations to lead global study programs, ensuring timelines, budgets, and quality standards across development stages.

You will oversee CROs and cross-functional teams, driving enrollment strategies and inspection readiness in a fast-paced biotech environment. Based at our Waltham, MA headquarters, this role requires in-office collaboration three days per week and strong leadership to mentor teams while aligning with Regulatory, Biometrics,

Qualifications

• BS/BA in Life Sciences or related field required.
• 5+ years leading clinical operations in biotech/pharma.
• Experience managing global trials and CROs.

Responsibilities

• Lead execution of global clinical programs, ensuring timelines and budgets.
• Provide operational leadership for cross-functional study teams.
• Oversee CROs/vendors, including governance and performance management.
• Develop study timelines, budgets, forecasts, and risk plans.
• Collaborate with Regulatory, Biometrics, Medical Affairs to align activities.
• Drive patient recruitment and site engagement strategies.

Skills

ICH-GCP knowledge

Cross-functional leadership

Regulatory knowledge

Project leadership

Communication

Travel readiness

Education

BS/BA in Life Sciences or related field

Advanced degree preferred

Tools

Microsoft Office Suite (Word/PowerPoint/Excel/SharePoint)

Job description

Description

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.

Description

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


• 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

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.