Senior Manager, Study Start-Up & Feasibility

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 Vice President, Clinical Operations, the Senior Manager, Clinical Operations Study Start-Up, Feasibility & Site Management is responsible for leading feasibility, site identification, site engagement, startup planning, and site relationship management activities across one or more clinical development programs. This role partners closely with Clinical Operations leadership, study teams, CRO partners, investigators, and cross-functional stakeholders to ensure efficient study startup, enrollment readiness, and successful activation of high-performing investigative sites aligned with development timelines and operational objectives.

This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Lead study startup, feasibility, site identification, and site management activities across assigned studies and programs
• Develop and execute study startup strategies aligned with clinical development objectives, timelines, and enrollment goals
• Lead site identification, qualification, and selection activities in collaboration with study teams and CRO partners
• Evaluate feasibility data, enrollment projections, site performance metrics, and startup assumptions to support study planning and decision making
• Develop and maintain site strategy plans, startup forecasts, and enrollment readiness assessments
• Establish and maintain strong relationships with investigators, site personnel, site networks, and key external stakeholders
• Drive site engagement initiatives that support enrollment, retention, and study execution objectives
• Partner with CROs and vendors to ensure startup activities are executed efficiently and according to agreed timelines
• Monitor startup performance metrics and identify risks, trends, and opportunities for improvement
• Lead startup governance meetings, risk reviews, and operational planning activities
• Partner with Clinical Operations leadership regarding site performance, startup progress, and enrollment readiness
• Collaborate with Medical, Regulatory Affairs, Biometrics, Clinical Development, and other stakeholders during startup planning and execution
• Develop and implement mitigation plans for startup delays, feasibility concerns, and site performance challenges
• Support development and refinement of startup processes, metrics, and operational best practices
• Lead startup-related lessons learned and continuous improvement initiatives
• Support budget planning and forecasting activities related to startup and site management activities
• Mentor and develop Clinical Operations personnel as appropriate
• Drive operational excellence initiatives related to startup execution and site management
• Support inspection readiness activities related to startup and site management documentation
• Ensure activities are conducted in accordance with company procedures, ICH-GCP guidelines, and applicable regulations

• BA/BS degree in Health Sciences, Life Sciences, or related discipline required; advanced degree preferred
• Minimum of 8 years of experience within the pharmaceutical, biotechnology, medical device, and/or CRO industry
• Significant experience in clinical operations, study startup, feasibility, site management, or related disciplines
• Demonstrated experience leading startup activities across multiple clinical trials and development programs
• Experience leading investigator identification, site selection, and enrollment planning activities
• Experience evaluating feasibility outputs, enrollment assumptions, and operational startup strategies
• Strong understanding of country and site startup processes across global clinical trials
• Experience managing CROs, startup vendors, and strategic site partners
• Experience supporting enrollment planning and site performance optimization activities
• Demonstrated success leading complex cross-functional initiatives
• Strong understanding of clinical trial regulations, startup requirements, and ICH-GCP guidelines
• Strong business and operational acumen
• Exceptional collaboration, communication, and interpersonal skills
• Reliable, self-motivated, team player
• Creative problem solver
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong attention to detail with exceptional organizational skills
• Ability to work in a fast-paced environment and handle multiple tasks and competing priorities
• Strong commitment to ethical standards
• Advanced proficiency with Microsoft Office Suite, Microsoft Project, Smartsheet, or similar tools
• Ability to travel as needed
• 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 coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• 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 mental, financial, and proactive physical health programs covered by Viridian

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.