Associate Director, Clinical Trial Lead, Clinical Operations
Cabaletta Bio
August 18, 2026
Remote
United States
Clinical Research and Development
Associate Director, Clinical Trial Lead, Clinical Operations
Key Responsibilities
- Lead planning, execution, management, and delivery of assigned regional/global clinical trials from protocol through conduct, closeout, analysis, and reporting.
- Provide operational leadership across study startup, site activation, patient recruitment/enrollment, monitoring oversight, protocol deviation management, data review/cleaning, database lock readiness, and study closeout.
- Serve as primary operational liaison among internal cross-functional teams and external stakeholders (e.g., CROs, sites, vendors, regulatory, QA, safety, data management, medical writing, translational research, clinical supply).
- Oversee selection, onboarding, management, and performance of CROs/vendors to meet timelines, quality, contractual, and budget requirements.
- Develop/author/review/approve key trial and operational documents (protocols/amendments, informed consents, study manuals/plans, regulatory responses, clinical study reports).
- Manage study budgets, forecasts, work/change orders, and financial performance.
- Use project management methodologies/metrics to track progress, identify/mitigate risks, and support decision-making.
- Drive process improvements (including remote monitoring strategies and optimized clinical supply management).
- Ensure compliance with ICH-GCP, applicable regulations, and company SOPs (manage quality issues, CAPAs, inspection/audit/regulatory readiness).
- Perform required in-house operational activities.
- Mentor/develop/directly manage In-house CRAs/contingent workers and other assigned personnel; support continuous improvement and SOP/procedure development.
Qualifications & Experience
- BA/BS in scientific or healthcare-related discipline (required).
- 8–10+ years clinical research experience; significant global clinical trial management in biotech/pharma (required).
- Proven leadership of complex clinical studies (budgets, timelines, vendors/resources, risk).
- Extensive experience managing CROs/vendors and cross-functional teams in matrix environments.
- Strong knowledge of clinical trial operations, ICH-GCP, regulatory requirements, inspection readiness.
- Experience across early and late-phase development.
- Broad matrix knowledge across regulatory, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing.
- Cell/gene therapy or oncology experience preferred.
- Travel up to 10% as required.
Application
- https://www.cabalettabio.com/join-our-crew
Key Responsibilities
- Lead planning, execution, management, and delivery of assigned regional/global clinical trials from protocol through conduct, closeout, analysis, and reporting.
- Provide operational leadership across study startup, site activation, patient recruitment/enrollment, monitoring oversight, protocol deviation management, data review/cleaning, database lock readiness, and study closeout.
- Serve as primary operational liaison among internal cross-functional teams and external stakeholders (e.g., CROs, sites, vendors, regulatory, QA, safety, data management, medical writing, translational research, clinical supply).
- Oversee selection, onboarding, management, and performance of CROs/vendors to meet timelines, quality, contractual, and budget requirements.
- Develop/author/review/approve key trial and operational documents (protocols/amendments, informed consents, study manuals/plans, regulatory responses, clinical study reports).
- Manage study budgets, forecasts, work/change orders, and financial performance.
- Use project management methodologies/metrics to track progress, identify/mitigate risks, and support decision-making.
- Drive process improvements (including remote monitoring strategies and optimized clinical supply management).
- Ensure compliance with ICH-GCP, applicable regulations, and company SOPs (manage quality issues, CAPAs, inspection/audit/regulatory readiness).
- Perform required in-house operational activities.
- Mentor/develop/directly manage In-house CRAs/contingent workers and other assigned personnel; support continuous improvement and SOP/procedure development.
Qualifications & Experience
- BA/BS in scientific or healthcare-related discipline (required).
- 8–10+ years clinical research experience; significant global clinical trial management in biotech/pharma (required).
- Proven leadership of complex clinical studies (budgets, timelines, vendors/resources, risk).
- Extensive experience managing CROs/vendors and cross-functional teams in matrix environments.
- Strong knowledge of clinical trial operations, ICH-GCP, regulatory requirements, inspection readiness.
- Experience across early and late-phase development.
- Broad matrix knowledge across regulatory, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing.
- Cell/gene therapy or oncology experience preferred.
- Travel up to 10% as required.
Application
- https://www.cabalettabio.com/join-our-crew