Senior Director, Clinical Trial Operations

Insmed Incorporated • NJ Corporate Headquarters, NJ

1d • $222,000 - $303,000 • Remote

About The Position

We’re looking for a Senior Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Development Operations, you’ll provide strategic leadership and operational oversight for clinical trials across Insmed's development pipeline. This role is responsible for ensuring the successful planning and execution of clinical studies from protocol development through study closeout, while maintaining the highest standards of quality, compliance, and patient safety.

Requirements

• Bachelors degree in life sciences, healthcare or a related field
• 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry
• 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.

Nice To Haves

• Experience in rare disease or respiratory therapeutic areas.
• Experience with adaptive trial designs and innovative clinical trial methodologies.
• Experience with regulatory submissions and Heath Authority inspections.

Responsibilities

• Develop and implement clinical operations strategies, aligned with corporate objectives and Program goals.
• 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.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Senior