Respicardia

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: $150,000-$175,000

This position is bonus eligible.

Job Summary

This position is responsible for leading a growing team to ensure excellence in the design, development, and execution of clinical trials in collaboration with Clinical Operations and cross-functional partners. It provides strategic and operational leadership to ensure that team activities are consistent with legal and regulatory standards and company policies. This role combines people management with hands-on contribution, overseeing key Clinical Affairs functions and supporting clinical strategy and execution.

Essential Functions

• Lead and manage 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.
• Develop clinical study protocols, procedures and supporting documentation to support new clinical projects at all phases of development.
• Manage internal teams, Contract Research Organizations (CROs), vendors, and consultants supporting site management and trial operations.
• Ensure appropriate resource allocation and prioritization across assigned clinical programs.
• Develop and manage study budgets and timelines.
• Implement and manage remote and risk-based monitoring strategies.
• Lead cross-functional team meetings and provide regular updates to senior leadership.
• Manage clinical activities, including study initiation for clinical sites, site recruitment and preparation, facilitation of Institutional Review Board (IRB) approvals process and readiness for enrollments.
• Participate in initial and transitional education for clinical site personnel and field team representatives (e.g., Territory Managers, Clinical Specialists) on protocols, processes, and products.
• Ensure compliance with appropriate regulatory requirements (e.g., International Council for Harmonization Good Clinical Practice (ICH-GCP), Competent Authorities (CA), Ethics Committees (EC)) and internal Standard Operating Procedures (SOPs), Work Instructions (WI), policies, and procedures.
• Support audit readiness and provide management level representation during 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 field required with demonstrated clinical research experience; advanced degree preferred
• 5+ years of leadership experience in clinical or scientific research within the medical device industry; experience in the fields of cardiology or sleep medicine preferred
• Minimum of 3-4+ years of direct people management experience, including leading and developing teams
• Experience with Premarket Approval (PMA) device preferred
• Demonstrated people management experience, including performance evaluations and development of employee goals and objectives
• Experience working with clinical research centers across all phases of clinical trials, including site activation, enrollment and closeout
• Proficiency 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 in Good Clinical Practice (GCP) and applicable global regulations and standards, including ISO, 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 trial strategies aligned with organizational 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
• Able to perform work with general direction, exercising sound judgement and initiative in managing projects and assignments
• Ability to interpret, communicate, and present clinical data clearly to diverse audiences
• Proven interpersonal and leadership skills, with the ability to influence and build relationships with physicians, customers, and stakeholders
• Effective team 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

The annual salary for this position is:
$150,000.00 to $175,000.00

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.