Director of Clinical

Custom Search Inc.; Minneapolis (MN); Sur place; USD 190 000 - 230 000; Plein temps

Résumé du poste

Custom Search Inc. is seeking a Director of Clinical Affairs to lead clinical execution across two IDE studies, manage a team of five Project Managers, and strengthen operations to support FDA-ready documentation and site management.

The ideal candidate will be a hands-on clinical leader with strong cross-functional influence, capable of balancing strategic planning with daily operational leadership in a fast-paced medical device environment.

Qualifications

• 10+ years of clinical research experience in medical devices.
• 5+ years U.S. medical device clinical research, including IDEs.
• Previous people-management experience required.
• Experience at Program Manager/Director level or higher.
• Class II/III medical device experience preferred.
• Strong knowledge of GCP, FDA regulations, and clinical quality systems.
• Experience developing or improving clinical operations infrastructure.
• Experience supporting FDA audits or regulatory inspections valued.

Responsabilités

• Lead, mentor, and develop a team of five clinical Project Managers for site management and study execution.
• Drive execution across two IDE studies and ensure milestone progress.
• Lead clinical data cleanup, documentation review, and pre-audit preparation.
• Ensure programs are inspection-ready and compliant with SOPs and procedures.
• Oversee site-management activities, including site performance and issue resolution.
• Establish and maintain clinical operations SOPs, policies, and workflows.
• Support development and execution of study plans, timelines, budgets, and resources.
• Identify risks and gaps, and implement mitigating solutions.
• Partner cross-functionally with Clinical, Regulatory, Data Management, and leadership.
• Provide clear direction to the team and manage competing priorities.
• Build relationships with sites, investigators, CROs, and third-party partners.
• Oversee documentation, trial master files, safety monitoring, and reporting.
• Participate in site visits to strengthen site-management processes.

Connaissances

People management

Clinical study execution

Regulatory compliance

GCP knowledge

IDE studies

Cross-functional leadership

Budget planning

Site management

Formation

Bachelor's degree in life sciences/engineering

Outils

CTMS

Clinical documentation systems

Description du poste

Our client, a well-funded start-up cardiovascular medical device company, is seeking a Director of Clinical Affairs to lead clinical execution across two ongoing IDE studies. This newly created leadership role will manage a team of five Project Managers, strengthen clinical operations processes, and drive study execution, audit readiness, and site management.

The ideal candidate will be a confident, hands-on clinical leader who understands what needs to happen, builds strong relationships, and is comfortable offering informed opinions. This person must be able to move easily between people leadership, strategic planning, and detailed operational execution in a fast-paced medical device environment.

Your role with the company:

• Lead, mentor, and develop a team of five clinical Project Managers responsible for site management and clinical study execution.

• Drive execution across two ongoing premarket IDE studies.

• Lead clinical data cleanup, documentation review, and pre-audit preparation for the company's lead clinical study.

• Ensure clinical programs remain inspection-ready and compliant with applicable regulations, standards, SOPs, and company procedures.

• Oversee site-management activities, including site performance, documentation, issue resolution, and closeout visits.

• Establish, improve, and maintain clinical operations SOPs, policies, procedures, and workflows.

• Support the development and execution of clinical strategies, study plans, timelines, milestones, budgets, and resource requirements.

• Identify operational risks, gaps, and priorities while proactively recommending and implementing solutions.

• Partner cross-functionally with Clinical, Safety, Regulatory, Data Management, Therapy Development, European operations, and company leadership.

• Provide clear direction to the team while helping employees manage competing priorities and interdepartmental challenges.

• Build productive relationships with clinical sites, investigators, CROs, core laboratories, consultants, and other third-party partners.

• Oversee clinical documentation, trial master files, site reports, data collection, safety monitoring, and regulatory or IRB/Ethics reporting.

• Participate in site visits as needed to understand team activities and strengthen site-management processes.

Clinical Programs

The Director will support two active clinical studies:

• A lead study of approximately 500 patients that is about 75% enrolled, with an immediate emphasis on data cleanup and audit readiness.

• A second study of approximately 100 patients that is about 25% enrolled.

Enrollment for both studies is expected to continue over the next several years. The company is targeting FDA approval within approximately two to three years and is financially prepared to advance the technology through commercialization.

Desired Profile:

• At least 10 years of clinical research experience, preferably within the medical device industry.

• Five or more years of U.S. medical device clinical research experience, including IDE studies.

• Previous people-management experience required.

• Current or previous experience at the Program Manager, Senior Program Manager, Associate Director, or Director level.

• Class II or Class III medical device experience required.

• Strong knowledge of clinical study operations, site management, study design, GCP, FDA regulations, global clinical requirements, and clinical quality systems.

• Experience developing or improving clinical operations infrastructure, including SOPs, study documentation, policies, procedures, and workflows.

• Demonstrated ability to lead teams, drive execution, establish priorities, and navigate complex cross-functional relationships.

• Experience supporting FDA audits or regulatory inspections is highly valued but not required.

• Clinical monitoring experience is helpful but not required.

• Cardiovascular medical device experience is preferred but not required.

• Experience working within a start-up or emerging medical device company is preferred.

• Bachelor's degree in life sciences, engineering, or a related field preferred; relevant experience will also be considered.

Leadership Profile

The successful candidate will be:

• Confident, proactive, and comfortable making recommendations.

• Motivated by execution, problem-solving, and team development.

• Skilled at building relationships and influencing across departments.

• Able to balance strategic leadership with hands-on operational involvement.

• Comfortable working through ambiguity and changing priorities.

• Willing to bring prior experience and informed opinions to help strengthen the organization.

• Travel is expected to be no more than approximately 25% and will primarily involve occasional site visits, company meetings, and other clinical-program needs.