Senior Manager, Study Start-Up & Feasibility

DescriptionAt 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 regulationsRequirementsBA/BS degree in Health Sciences, Life Sciences, or related discipline required; advanced degree preferredMinimum of 8 years of experience within the pharmaceutical, biotechnology, medical device, and/or CRO industrySignificant experience in clinical operations, study startup, feasibility, site management, or related disciplinesDemonstrated experience leading startup activities across multiple clinical trials and development programsExperience leading investigator identification, site selection, and enrollment planning activitiesExperience evaluating feasibility outputs, enrollment assumptions, and operational startup strategiesStrong understanding of country and site startup processes across global clinical trialsExperience managing CROs, startup vendors, and strategic site partnersExperience supporting enrollment planning and site performance optimization activitiesDemonstrated success leading complex cross-functional initiativesStrong understanding of clinical trial regulations, startup requirements, and ICH-GCP guidelinesStrong business and operational acumenExceptional collaboration, communication, and interpersonal skillsReliable, self-motivated, team playerCreative problem solverDemonstrated strong written and verbal communication skillsProven mindset of proactive continuous improvementEfficient independent worker with ability to focus and drive for resultsStrong attention to detail with exceptional organizational skillsAbility to work in a fast-paced environment and handle multiple tasks and competing prioritiesStrong commitment to ethical standardsAdvanced proficiency with Microsoft Office Suite, Microsoft Project, Smartsheet, or similar toolsAbility to travel as neededThe salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:Competitive pay and stock options for all employeesMedical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependentsFertility and mental health programsShort- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious mental, financial, and proactive physical health programs covered by ViridianViridian 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.Employee Type: FT Exempt