Director, Respiratory Clinical Operations (US Remote)

MERIT CRO, Inc.•Madison, WI

34d•Remote

About The Position

We are seeking a seasoned and dynamic Director to lead our growing Respiratory Clinical Operations team. The ideal candidate brings more than a decade of hands-on experience in respiratory clinical trials, with a strong foundation in IPF/ILD studies and deep familiarity with spirometry and HRCT. This role requires someone who has successfully managed central reviews and third-party contractors, and who has a demonstrated history of building and developing high-performing teams. If you thrive in an environment where structure is still taking shape and see that as an opportunity rather than an obstacle, we want to hear from you. This is a highly visible, cross-functional role that demands exceptional communication skills. You will interface directly with sponsors and vendors, translating complex clinical concepts into clear, actionable language for diverse audiences. We are looking for a natural leader who documents rigorously, pivots priorities without missing a beat, and is energized by the challenge of building something meaningful. Willingness to travel and a background that touches sales support will round out the ideal profile.

Requirements

Bachelor's degree in a scientific or health-related field required, Master's degree preferred.
PMP certification is a plus.
Minimum of 10 years of clinical research experience, with significant focus in respiratory clinical trials.
Expert knowledge of respiratory diseases and direct experience with spirometry and HRCT in a clinical trial context.
Minimum of 5 years of experience managing clinical trials as a Project Manager or in a comparable role at a pharmaceutical/biotech company or CRO.
Minimum of 2 years of supervisory experience with a demonstrated track record of developing and retaining talent.
Experience managing central reviews and third-party contractors/vendors.
Experience supporting business development activities including client presentations and bid defenses.
Exceptional written and verbal communication skills, with the ability to convey complex clinical concepts clearly to a wide range of audiences.
Proven ability to prioritize and manage multiple competing demands in a fast-paced, evolving environment.
Proficiency in Microsoft Office; ability to learn company-specific software.

Responsibilities

Lead and oversee all respiratory clinical operations across multiple concurrent studies, ensuring delivery on time, on budget, and in compliance with applicable regulations, SOPs, and ICH-GCP guidelines.
Bring demonstrated subject matter expertise in respiratory disease (IPF and other interstitial diseases, COPD, asthma, etc.) and direct experience with spirometry and HRCT as used in clinical trial settings, serving as an internal resource and credible voice with sponsors, vendors, and clinical staff alike.
Manage, mentor, and develop respiratory staff including Project Managers, Respiratory Therapists, and contractors and consultants, fostering a culture of accountability, growth, and high performance while actively monitoring workload and coverage.
Serve as the primary point of contact for sponsors and vendors, communicating project status, escalating issues proactively, and representing MERIT in client presentations, bid defenses, and day-to-day operational discussions with clarity and confidence.
Drive process improvement and department-building initiatives, including the development of SOPs, training programs, and scalable operational frameworks suited for a growing and evolving respiratory practice.
Oversee centralized data review processes and contractor relationships, ensuring quality control of respiratory and imaging data and timely resolution of discrepancies in partnership with data management and cross-functional teams.
Maintain rigorous documentation and communication standards across all programs, providing consistent status updates to senior leadership and ensuring all project activity is well-tracked, clearly reported, and audit-ready.