Senior Director, Clinical Trial Operations

Role Summary

Senior Director, Clinical Trial Operations. Remote position. Provide strategic leadership and operational oversight for clinical trials across Insmed's development pipeline, ensuring the successful planning and execution of studies from protocol development through study closeout with high standards of quality, compliance, and patient safety.

Responsibilities

• Provide functional subject matter expertise to the Global Program Team and develop clinical trial scenarios, options, timeline, and budget projections for decision-making.
• Leverage broad clinical trial industry and biotech leadership experience to think beyond the clinical operations function and contribute to setting strategy for the Program, as requested.
• Foster collaborative relationships with key external stakeholders, including clinical trial investigators, research coordinators and suppliers; cultivate important relationships with key internal stakeholders, including Insmed senior management and cross-functional leadership.
• Potentially serve on the Global Development Operations Leadership Team and contribute to setting Department strategy.
• Ensure high-quality, consistent planning and execution of Phase I–IV clinical trials, including oversight of study feasibility, site selection, trial recruitment, data monitoring, study closeout, TMF, and study risk management.
• Ensure compliance with GCP, FDA, EMA, and other regulatory requirements.
• Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and other departments on the Global Clinical Team, responsible for delivery of trials within a Clinical Development Plan.
• Partner with Procurement and Vendor Alliance Management to optimize external supplier performance, including establishing performance metrics, risk-sharing agreements, and partnership governance.
• Benchmark, track, report, and evaluate operational and trial metrics, with the ability to interpret complex issues and communicate program status in a concise fashion to an executive audience.
• Identify opportunities to improve the efficiency and/or effectiveness of clinical trial operations, develop strategies, make recommendations, and lead process improvement/enhancement initiatives.
• Lead, coach, and develop a high-performing team of clinical operations professionals.
• Manage resource allocation and capacity planning across multiple studies.
• Foster a culture of quality, accountability, and patient-centricity.

Qualifications

• Bachelor's degree in life sciences, healthcare or a related field.
• 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry and 5+ years in senior leadership roles managing clinical operations teams.
• Extensive experience across all phases of clinical research and across multiple therapeutic areas.
• Robust knowledge of GCP, FDA regulations, and international regulatory requirements.
• Proven track record of successful study execution and delivery in a fast-paced, dynamic environment.
• Strong vendor management skills and CRO oversight experience.
• Previous CRA/monitoring experience.
• Experience in rare disease or respiratory therapeutic areas.
• Experience with adaptive trial designs and innovative clinical trial methodologies.
• Experience with regulatory submissions and Health Authority inspections.

Additional Requirements

• Up to 25% domestic and international travel may be required for site visits, supplier meetings, and cross-functional/team collaboration.