Senior Director, Clinical Trial Operations
Insmed Incorporated
15 hours ago
Remote
United States
Operations
About the Role
Senior Director, Clinical Trial Operations (Clinical Operations). Reporting to the Vice President, Development Operations, provide strategic leadership and operational oversight for clinical trials across Insmed’s development pipeline. Ensure successful planning and execution of clinical studies from protocol development through closeout, maintaining quality, compliance, and patient safety.
What You’ll Do
- Develop and implement clinical operations strategies aligned with corporate and program goals.
- Provide subject matter expertise to the Global Program Team (clinical trial scenarios, options, timelines, budget projections).
- Use clinical trial and biotech leadership experience to contribute to program strategy.
- Build collaborative relationships with investigators, research coordinators, suppliers, and internal cross-functional leadership.
- Potentially serve on the Global Development Operations Leadership Team to help set department strategy.
- Ensure high-quality planning and execution of Phase I–IV trials (feasibility, site selection, recruitment, data monitoring, closeout, TMF, and risk management).
- Ensure compliance with GCP and regulatory requirements (FDA, EMA, and others).
- Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and others to deliver trials within the Clinical Development Plan.
- Partner with Procurement/Vendor Alliance Management to optimize supplier performance (metrics, risk-sharing, governance).
- Benchmark and report operational/trial metrics to executive audiences.
Who You Are / Qualifications
- Bachelor’s degree in life sciences, healthcare, or related field.
- 12+ years progressive clinical research/operations experience in pharma/biotech.
- 5+ years senior leadership managing clinical operations teams.
You Are Or You Also Have
- Experience across all phases and multiple therapeutic areas.
- GCP, FDA regulations, and international regulatory knowledge.
- Proven successful execution in fast-paced environments.
- Vendor management and CRO oversight; prior CRA/monitoring experience.
- Experience in rare disease or respiratory therapeutic areas; adaptive trial designs.
- Experience with regulatory submissions and Health Authority inspections.
Travel/Work
- Fully remote; up to 25% domestic/international travel.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Senior Director, Clinical Trial Operations (Clinical Operations). Reporting to the Vice President, Development Operations, provide strategic leadership and operational oversight for clinical trials across Insmed’s development pipeline. Ensure successful planning and execution of clinical studies from protocol development through closeout, maintaining quality, compliance, and patient safety.
What You’ll Do
- Develop and implement clinical operations strategies aligned with corporate and program goals.
- Provide subject matter expertise to the Global Program Team (clinical trial scenarios, options, timelines, budget projections).
- Use clinical trial and biotech leadership experience to contribute to program strategy.
- Build collaborative relationships with investigators, research coordinators, suppliers, and internal cross-functional leadership.
- Potentially serve on the Global Development Operations Leadership Team to help set department strategy.
- Ensure high-quality planning and execution of Phase I–IV trials (feasibility, site selection, recruitment, data monitoring, closeout, TMF, and risk management).
- Ensure compliance with GCP and regulatory requirements (FDA, EMA, and others).
- Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and others to deliver trials within the Clinical Development Plan.
- Partner with Procurement/Vendor Alliance Management to optimize supplier performance (metrics, risk-sharing, governance).
- Benchmark and report operational/trial metrics to executive audiences.
Who You Are / Qualifications
- Bachelor’s degree in life sciences, healthcare, or related field.
- 12+ years progressive clinical research/operations experience in pharma/biotech.
- 5+ years senior leadership managing clinical operations teams.
You Are Or You Also Have
- Experience across all phases and multiple therapeutic areas.
- GCP, FDA regulations, and international regulatory knowledge.
- Proven successful execution in fast-paced environments.
- Vendor management and CRO oversight; prior CRA/monitoring experience.
- Experience in rare disease or respiratory therapeutic areas; adaptive trial designs.
- Experience with regulatory submissions and Health Authority inspections.
Travel/Work
- Fully remote; up to 25% domestic/international travel.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.