Join Us in Shaping the Future of Respiratory Care

Position: Director Clinical Operations

Location: U.S. (Remote with ~25% travel)

Industry: Medical Device

Experience Level: 10 years

We are seeking an experienced Director of Clinical Operations to lead the operational execution of our clinical research programs. Reporting to the Vice President of Clinical Affairs, this role is responsible for managing clinical operations, leading a high- performing team, overseeing clinical studies, and ensuring projects are executed on time, within budget, and in compliance with regulatory requirements.

The ideal candidate is a collaborative leader with extensive medical device clinical research experience who thrives in a fast-paced, growing organization.

What You’ll Do

• Lead the Clinical Operations team in the successful execution of clinical studies aligned with development strategy and timelines.
• Develop, maintain, and manage clinical study timelines, milestones, and deliverables.
• Provide leadership, coaching, and oversight for members of the Clinical Operations team.
• Manage study budgets, vendor contracts, invoices, and financial tracking.
• Oversee Clinical Research Organizations (CROs), Clinical Research Associates (CRAs), and other external vendors to ensure quality performance.
• Partner with Field Clinical, Regulatory Affairs, Quality, and cross-functional teams to support clinical program execution.
• Monitor study progress and proactively identify and resolve operational challenges.
• Oversee the Clinical Trial Master File (TMF) to ensure inspection readiness and compliance.
• Review study plans, monitoring activities, and documentation to ensure compliance with FDA regulations, ICH Good Clinical Practice (GCP), and study protocols.
• Support the preparation and review of clinical documents, including protocols, informed consent forms, investigator brochures, monitoring plans, study reports, and annual IRB/Ethics Committee reports.
• Lead study start-up activities, including site contracts, site activation, IRB/Ethics Committee submissions, and vendor coordination.
• Support Regulatory Affairs with regulatory submissions, safety reporting, and clinical strategy.
• Partner with Quality during audits, inspections, and CAPA activities.
• Manage Investigator Meetings, Study Coordinator meetings, and other clinical training events.
• Support the development and implementation of Clinical Operations SOPs and process improvements.
• Train and mentor internal clinical staff and external partners.
• Prepare clinical updates and presentation materials for executive leadership and the Board of Directors.

What You Bring

• Bachelor’s degree required; advanced degree and/or scientific or healthcare background preferred.
• Minimum of 10 years of clinical research and clinical project management experience.
• Experience leading clinical operations within the medical device industry.
• Strong working knowledge of FDA regulations and ICH Good Clinical Practice (GCP) guidelines.
• Demonstrated experience managing CROs, vendors, study budgets, and complex clinical timelines.
• Proven leadership and people management experience.
• Excellent organizational skills with the ability to manage multiple priorities simultaneously.
• Outstanding written and verbal communication skills.
• Strong interpersonal skills with the ability to build relationships across investigators, sites, vendors, and cross-functional internal teams.
• Ability to work independently while driving collaboration across the organization.

Preferred Qualifications

• Advanced degree (Master’s or PhD) in a scientific or healthcare-related discipline.
• Experience supporting regulatory submissions and clinical strategy.
• Experience managing Trial Master Files (TMF) and ensuring inspection readiness.
• Experience developing SOPs and implementing quality process improvements.
• Experience supporting FDA inspections, audits, and CAPA management.
• Experience in a start-up or high-growth medical device environment.

Travel: Approximately 20–30%. including occasional international travel to Canada

Compensation: Actual compensation will be determined based on factors including
experience, qualifications, skills, education, geographic location, and internal equity. In
addition to base salary, this position may be eligible for bonus and a comprehensive
benefits package.

Why Join Us?

This is an exciting opportunity to play a key leadership role in advancing innovative medical technology that has the potential to improve patient outcomes. You’ll work alongside a passionate, collaborative team dedicated to bringing life-changing therapies to patients while helping shape the future of our growing Clinical Affairs organization.

Ready to make a real impact in patients’ lives and help bring life-changing therapy to the world? Send your resume and cover letter to [email protected] today and join Lungpacer’s mission to redefine respiratory support. Your clinical expertise and passion for patient care can help shape the future of medicine.

Position: Clinical Specialist II

Location: U.S. (Remote with ~75% travel)

Industry: Medical Device

Experience Level: 5-7 Years

Are you driven by purpose, energized by patient impact, and excited to support cutting-edge clinical research around the globe? Lungpacer is growing, and we are looking for a Clinical Specialist II to join our multidisciplinary Clinical Support team.

In this role, you will be on the front lines of innovation—supporting patient cases, partnering with leading investigators, and helping advance transformative respiratory therapy technologies across clinical trials and early commercial environments.

If you thrive in fast-paced clinical settings, love building relationships with hospital teams, and want your work to change lives, this is your opportunity.

What You Will Do

As a Clinical Specialist II, you will play a key role in supporting global clinical trial execution and patient care. You will:

• Support patient cases, provide treatment support, and drive clinical trial enrollment—pre-market and post-market.
• Travel (up to 75%, including internationally) to clinical trial sites to provide hands-on support.
• Train and mentor new Clinical Specialists, and educate site personnel including coordinators, physicians, RNs, and RRTs.
• Partner closely with Clinical Operations, Regulatory, Engineering, and Marketing teams to support strategic clinical projects.
• Deliver and refine device and therapy training for hospital teams.
• Build and nurture strong relationships with PIs, KOLs, referring physicians, and study staff to ensure robust enrollment.
• Provide input into clinical protocols, SOPs, work instructions, and patient recruitment initiatives.
• Respond to customer questions and track complaints in accordance with quality system requirements.
• Maintain expert-level knowledge of respiratory and critical care therapy landscapes, device troubleshooting, and competitor environments.
• Ensure all work adheres to Good Clinical Practice (GCP), ISO 14155, and regulatory standards.

What You Bring (Required Qualifications)

You will excel in this role with:

• A bachelor’s degree in nursing, respiratory therapy, medicine, or biology.
• Active licensure in your field, maintained per Clinical Affairs guidance.
• Minimum 5 years of experience in clinical research, ICU nursing/respiratory therapy, or clinical medical device support.
• Strong project management skills and the ability to juggle multiple priorities in a fast-paced environment.
• Ability to adapt quickly to changing priorities.
• Excellent verbal and written communication skills.
• Demonstrated ability to work independently and within cross-functional teams.
• Proficiency in ICH 14155 and GCP guidelines.
• Strong interpersonal skills and confidence interacting across hospital staff, investigators, vendors, and internal teams.

Preferred Qualifications

You will shine even brighter if you have:

• At least 3 years of experience with similar technologies or clinical support roles.
• Demonstrated clinical excellence as it relates to product knowledge and customer support.
• Legacy product or relevant therapeutic area knowledge.
• Experience mentoring or training junior clinical specialists.
• Demonstrated clinical leadership and ability to assume expanded responsibilities as the organization grows.

You are a Great Fit If…

• You are excited by extensive travel and enjoy being in the field supporting clinicians and patients.
• You are energized by building relationships and encouraging high engagement at research sites.
• You are skilled at navigating complex clinical environments—from ICUs to long-term acute care settings.
• You adapt quickly, stay organized under pressure, and communicate with poise in any situation.
• You want to contribute to a mission-driven company bringing meaningful innovation to respiratory and critical care medicine.

 

Compensation: Actual compensation will be determined based on factors including experience, qualifications, skills, education, geographic location, and internal equity. In addition to base salary, this position may be eligible for bonus and a comprehensive benefits package.

Ready to make a real impact in patients’ lives and help bring life-changing therapy to the world? Send your resume and cover letter to [email protected] today and join Lungpacer’s mission to redefine respiratory support. Your clinical expertise and passion for patient care can help shape the future of medicine.