Director, Clinical Trial Operations

Clinical Operations Leader

At Insmed, every moment and every patient countsand so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role :

Accountable for providing the leadership, strategic, operational planning and oversight of 1-2 indications within one compound to ensure all are delivered on time, within budget and with high quality. This role may manage clinical operations team members, as delegated by supervisor, to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company efficiency and productivity, regionally, and globally. This role can be hybrid or remote.

What You'll Do :

• Primary operational lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of operational aspects of regional and global studies as appropriate, including timelines, budget, data delivery and reporting, vendor management, GCP, etc.
• Develops operational strategies for implementation of clinical studies regionally / globally in conjunction with project teams and other cross functional departments.
• Ensure a "Quality Mindset" is in place across the organization by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and working closely with our QA organization to implement and manage a process for Inspection Readiness.
• Contributes to the development and review of regional / global policies and procedures. Ensure compliance with all Company / Regulatory requirements & TMF quality standards.
• Work with outsourcing / procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions.
• Provide leadership to Clinical Operations staff and to project teams for vendor evaluation, selection, management and quality-based oversight.
• Responsible for the management and leadership of the operations staff within the Clinical Operations group including recruitment, training, mentoring, career development, work assignments, performance evaluations and ongoing feedback to and of staff.
• Benchmark, track and report operational and study metrics with the ability to digest complicated or complex issues and communicate program statuses in a concise fashion to an executive audience with the ability to identify critical path items and mitigation plans.
• Oversight of compound budget with the ability to manage variance to a minimal threshold. Ability to manage the accrual process as well as provide budget forecasting and scenario planning based on multiple study designs.
• Able to represent Clinical Operations in a professional manner to executive audiences including attendance at requested meetings (i.e., Global Clinical Team, Global Project Team, etc.)

Who You Are :

Pay Range : $179,000.00-250,800.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our missionintentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include :

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.