Director, Respiratory Clinical Operations (US Remote)

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Director, Respiratory Clinical Operations (US Remote)

Full Time REMOTE WI, Madison, WI, US

Summary:

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.

Essential Duties and Responsibilities (other duties may be assigned):

• 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.

Other:

• Performs other duties as assigned
• Ability and willingness to travel up to 10%

Qualification Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

• 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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

The noise level in the work environment is usually quiet to moderate

Benefits Offered:

401k retirement plan, 8 Paid Holidays, Healthcare Insurance, Paid Life and AD&D Insurance, Paid Long-Term Disability, Paid Time Off (vacation & sick) and Work life balance.