Director, Respiratory Clinical Operations

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🕒 April 14

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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MERIT CRO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 $1.1M Venture Round - MERIT on 2023-07

Healthcare • Pharmaceuticals • SaaS

MERIT CRO is an innovative clinical endpoint expert and contract research organization that partners with CROs, pharmaceutical and biotech sponsors to provide centralized endpoint services for global clinical trials. It focuses on therapeutic areas including ophthalmology, oncology, respiratory and cardiology and offers specialized services such as reading center services, BCVA certification, centralized image storage, endpoint assessments, and clinical operations support. MERIT also provides a cloud-based software platform (EXCELSIOR) for real-time, single-system access to trial endpoints and emphasizes quality and compliance evidenced by ISO 13485 and ISO 27001 certifications and FDA 510(k) clearance. The company positions itself as a B2B service provider aimed at improving the reliability and efficiency of imaging- and endpoint-driven clinical trials.

📋 Description

• 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. • Manage, mentor, and develop respiratory staff including Project Managers, Respiratory Therapists, and contractors and consultants. • 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. • 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.

🎯 Requirements

• Bachelor's degree in a scientific or health-related field required, Master's degree preferred. • 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. • Exceptional written and verbal communication skills, with the ability to convey complex clinical concepts clearly to a wide range of audiences. • Proficiency in Microsoft Office; ability to learn company-specific software.

🏖️ Benefits

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