Respicardia
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.
As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.
Job Type / Location
Hybrid - Minnetonka, MN
This role offers a hybrid schedule, with an expectation of spending 3 to 4 days per week in our Minnetonka office. Being in the office regularly helps with team connection, collaboration, and staying plugged into the day-to-day, while still offering flexibility to work remotely. You’ll partner with your team both in person and virtually to build relationships, support their work, and contribute to a strong, high-performing environment.
Job Salary
Annual Base Salary: $175,000-$200,000
This position is bonus eligible.
Job Summary
This position is responsible for establishing and leading the Clinical Operations function while directly managing a team of Clinical Operations professionals and contractors responsible for the execution of the company's clinical study portfolio. This role provides organizational leadership and operational oversight across all clinical trial activities to ensure successful execution of clinical programs, regulatory compliance, and achievement of business objectives. The Director partners closely with the Chief Medical Officer and cross-functional stakeholders to support product development and regulatory objectives.
Essential Functions
- Lead and oversee clinical trial operational execution, including site and principal investigator identification, subject recruitment, investigator meetings, monitoring, trial master files maintenance, and resolution of site performance issues.
- Lead the development of clinical study protocols, procedures and supporting documentation for clinical programs across all phases of development.
- Manage internal team, Contract Research Organizations (CROs), vendors, and consultants supporting site management and clinical trial execution.
- Ensure appropriate resource allocation and prioritization across the clinical programs.
- Develop and maintain the Clinical Operations function, infrastructure, operating model, and capabilities.
- Lead, coach, and develop a team of professionals and contractors, fostering a culture of accountability, collaboration, and continuous improvement.
- Establish and monitor study startup, enrollment, monitoring, and closeout performance metrics.
- Drive operational excellence initiatives to improve study timelines, quality, scalability, and cost efficiency.
- Create and enhance standardized tools, templates, and processes across all clinical programs.
- Develop and oversee study budgets, timelines, forecasts, and resource plans.
- Establish and manage in-person, remote and risk-based monitoring strategies.
- Lead cross-functional team meetings and provide operational updates, risk assessments, and recommendations to senior leadership.
- Oversee clinical activities, including site startup activities, including site recruitment, qualification, activation, Institutional Review Board (IRB) approvals, and enrollment readiness.
- Provide oversight and support in initial and transitional education for clinical site personnel and field team representatives (e.g., Territory Managers, Clinical Specialists) on study protocols, processes, and products.
- Ensure compliance with applicable global clinical research regulations and standards, including ISO 14155, International Council for Harmonisation Good Clinical Practice (ICH-GCP), Competent Authorities (CA), Ethics Committees (EC), and internal Standard Operating Procedures (SOPs), Work Instructions (WI), policies, and procedures.
- Lead audit readiness efforts and provide Clinical Operations leadership representation during internal, external, and regulatory audits.
- Maintain and update internal documentation as needed.
- Provide meaningful, timely, and accurate updates to executive level leadership as needed.
- Maintain and monitor team workload, performance, and quality.
- Assess and manage direct reports’ learning and development opportunities.
- Conduct annual and ongoing performance reviews with recommendations for compensation changes, promotions, and disciplinary action as appropriate.
- Participate in the interviewing, hiring, and retention of highly engaged and diverse employees.
- Set a professional example in alignment with ZOLL’s Leadership Qualities.
- Execute company strategic business plans and long and short-term objectives.
Required/Preferred Education and Experience
- Bachelor's Degree in a scientific, healthcare, or related field required; advanced degree (e.g., MS, MPH, PhD, RN, or equivalent) preferred
- 5+ years of direct people management experience, including building, developing, and leading high-performing clinical research teams through coaching, performance management, employee development, and succession planning
- Experience with Premarket Approval (PMA) device preferred
- Experience leading clinical programs across multiple phases of development, including first-in-human, pilot, pivotal and post-market clinical studies
- Experience working with clinical research centers across all phases of clinical trials, including site activation, enrollment and closeoutProficiency with clinical trial management systems, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Trial Master Files (eTMF)
- Experience applying and implementing risk-based quality management and risk-based monitoring approaches
- Proven ability to collaborate with stakeholders within multiple organizational levels on significant matters, often requiring coordination across functions
Knowledge, Skills and Abilities
- Strong clinical background with a comprehensive knowledge and application of business concepts, procedures and practices
- Proficiency of clinical research regulations and standards, including ICH-GCP, U.S. Food and Drug Administration (FDA) regulations, Code of Federal Regulations (CFR), and European Medical Device Regulation (MDR)
- Excellent verbal and written communication skills, with the ability to effectively engage clinicians, key opinion leaders, and senior leadership
- Strong project management skills with the ability to manage multiple priorities and meet deadlines
- Ability to develop and execute clinical operations strategies aligned with organizational, regulatory, and business objectives
- Advanced analytical and problem-solving skills, including the ability to assess complex situations and evaluate multiple technical and strategic options
- Demonstrated ability to work effectively in a cross-functional, team-oriented environment and manage competing priorities
- Strong business acumen with the ability to link internal and external activities with market trends in the clinical trial space to drive operational efficiencies
- Demonstrated ability to exercise sound judgment and independent decision-making in managing clinical operations activities, resources, and organizational priorities
- Ability to interpret, communicate, and present clinical data clearly to diverse audiences
- Strong interpersonal and leadership skills, with the ability to influence and build effective relationships across all levels of the organization and with external stakeholders (e.g., physicians, customers)
- Effective people leadership skills, with the ability to perform in a fast-paced, high-visibility environment
Travel Requirements
- Ability to travel (including overnight stays) 25%
Physical Demands
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.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
The annual salary for this position is:
$175,000.00 to $200,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.