Associate Director Clinical Operations
$195,000–$195,000 year
On-siteBoston, Massachusetts, United States
Boston, Massachusetts, United StatesOn-siteFull Time$195,000–$195,000 yearSenior LevelBIOTECHSmall
Full TimeSenior LevelSmallBIOTECH
Job Summary
Manage clinical trials across all phases, oversee CROs and vendors, and ensure compliance with ICH/GCP guidelines and company SOPs. Develop operational strategies and clinical plans to support the development program, while overseeing site feasibility assessments and protocol review. Forecast trial materials, manage budgets and financial reporting, and perform Sponsor Oversight of outsourced activities. Represent Vor externally to investigators and key opinion leaders, lead trial manager teams, and facilitate inspection readiness for audits.
Required Qualifications
- BA or BS in a scientific, life science, or health-related discipline
- Minimum of 8 years of experience in clinical research
- At least 5 years of managing trials in the biotech/pharma industry and/or prior CRO experience
- Experience in setup, execution, and oversight/operational management of autoimmune trial experience
- Experience working on late-stage studies (Phase II, III)
- Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials
- Proficient in MS Office Suite
- Understanding of Clinical Trial Management System, eTMF, and EDC systems
- Ability/willingness to travel as required
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
Desired Qualifications
- Advanced degree
- Sjogren's and/or Myasthenia Gravis experience
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