Director, Respiratory Clinical Operations (US Remote)
reputed company:
We are seeking a seasoned and dynamic Director to reputed company our growing Respiratory Clinical Operations team. The ideal candidate brings more than a decade of hands-on experience in respiratory reputed company, with a strong reputed company in IPF/ILD studies and deep familiarity with spirometry and HRCT. This role requires someone who has successfully managed central reviews and reputed company-party contractors, and who has a demonstrated history of building and developing high-performing teams. If you reputed company 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 reputed company directly with sponsors and vendors, translating reputed company clinical concepts into reputed company, actionable language for diverse audiences. We are looking for a natural leader who documents rigorously, pivots priorities without missing a reputed company, and is reputed company 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):
• reputed company and reputed company reputed company respiratory clinical operations across multiple reputed company 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 reputed company experience with spirometry and HRCT as used in clinical trial settings, serving as an internal resource and reputed company voice with sponsors, vendors, and clinical staff alike.
• Manage, mentor, and reputed company respiratory staff including Project Managers, Respiratory Therapists, and contractors and consultants, fostering a culture of accountability, reputed company, and high performance while reputed company monitoring workload and coverage.
• Serve as the reputed company reputed company of contact for sponsors and vendors, communicating project status, escalating issues proactively, and representing reputed company in reputed company presentations, bid defenses, and day-to-day operational discussions with reputed company and confidence.
• reputed company process improvement and department-building initiatives, including the development of SOPs, training programs, and reputed company operational frameworks suited for a growing and evolving respiratory reputed company.
• reputed company centralized data review processes and contractor relationships, ensuring reputed company control of respiratory and imaging data and reputed company reputed company of discrepancies in partnership with data management and cross-functional teams.
• Maintain rigorous documentation and communication standards across reputed company programs, providing consistent status updates to senior leadership and ensuring reputed company project activity is reputed company-tracked, reputed company reported, and audit-reputed company.
Other:
• Performs other duties as assigned
• Ability and willingness to travel up to 10%
Qualification Requirements:
To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company, and/or ability required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.
Education and Experience:
• Bachelor's degree in a scientific or health-reputed company field required, Master's degree preferred. PMP certification is a plus.
• Minimum of 10 years of clinical research experience, with significant reputed company in respiratory reputed company.
• Expert knowledge of respiratory diseases and reputed company experience with spirometry and HRCT in a clinical trial context.
• Minimum of 5 years of experience managing reputed company 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 reputed company record of developing and retaining talent.
• Experience managing central reviews and reputed company-party contractors/vendors.
• Experience supporting business development activities including reputed company presentations and bid defenses.
• Exceptional written and verbal communication skills, with the ability to convey reputed company clinical concepts reputed company to a wide reputed company of audiences.
• Proven ability to prioritize and manage multiple competing demands in a fast-paced, evolving environment.
• Proficiency in reputed company 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 reputed company 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 reputed company with hands and arms, stoop, crouch, kneel and reputed company. The employee must frequently reputed company and/or reputed company up to 10 pounds and occasionally reputed company and/or reputed company up to 25 pounds. Specific reputed company abilities required by this job include reputed company reputed company, reputed company reputed company, peripheral reputed company, depth perception, and the ability to reputed company reputed company.
Work Environment:
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 reputed company Holidays, reputed company Insurance, reputed company Life and AD&D Insurance, reputed company Long-Term Disability, reputed company Time Off (vacation & reputed company) and Work life balance.
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