Vice President of Clinical Affairs

SecondWave Systems•Saint Paul, MN

11h•Hybrid

About The Position

At SecondWave Systems, we have developed a novel noninvasive approach to treat rheumatoid arthritis and other chronic and acute inflammatory disorders. Our SecondWave MINI device uses proprietary ultrasound technology on a wearable, personalized stimulation platform, giving patients and their physicians a new option for treating multiple health conditions. SecondWave consists of a diverse, multi-disciplinary team that is focused on bringing this new technology to patients with quality and speed. As a fast-growing startup, we move quickly and approach each day with both focus and flexibility. We expect new challenges, attack them with confidence and creativity, and find new opportunities within them. We each wear multiple hats and enjoy taking on new responsibilities and growing into new areas. If you thrive in this kind of environment, then we look forward to speaking with you. We are seeking a highly experienced and strategic clinical executive to join SecondWave Systems as Vice President of Clinical Affairs, who will report to the Chief Scientific Officer. This role is critical to advancing our mission of transforming the treatment for inflammatory health conditions through our noninvasive ultrasound platform. As Vice President of Clinical Affairs, you will provide vision, leadership, and operational management and reporting for all clinical programs of the company, ensuring that studies are scientifically rigorous, compliant with regulatory requirements and high ethical standards, and aligned with both business and patient-focused objectives. You will lead and mentor a growing clinical team involved with clinical trials and operations, medical affairs, writing of clinical study documents and manuscripts, and supporting national and international regulatory processes. You will also serve as the company’s primary clinical liaison to external stakeholders, including key opinion leaders (KOLs), study investigators, CROs, regulatory agencies, reimbursement experts, and clinical partners. Your leadership role will be responsible for the design, execution, monitoring, data management/analysis, and interpretation of trials that define the safety, efficacy, and clinical utility of SecondWave’s platform. In this role, you will partner closely with engineering, regulatory, and commercial teams to translate clinical insights into actionable strategies that guide product development, regulatory submissions, reimbursement strategy, and commercialization. You will also work closely with the finance team to manage clinical budgets, resource planning, and forecasting. This position is ideal for a seasoned clinical leader who is passionate about shaping the future of device-based therapies within a pharmaceutical ecosystem, thrives in a fast-paced and entrepreneurial environment, and has the ability to balance strategic vision with hands-on execution. You will have the opportunity to further define SecondWave’s clinical footprint, influence the development of first-in-class technology, and play a pivotal role in delivering meaningful outcomes to patients. This job description is subject to change and management reserves the right to assign or remove duties and responsibilities of this job at any time.

Requirements

Master’s degree or higher in a relevant discipline (medicine, life sciences, biomedical engineering, or equivalent), preferably with expertise in inflammatory disorders and medtech therapies; MD or PhD preferred.
15+ years of clinical development experience, including significant experience in leadership or executive roles.
Proven track record designing, executing, and delivering clinical trials, preferably studies that have led to regulatory approvals including in the United States and other countries.
Experience interacting with regulatory agencies and preparing regulatory submissions.
Strong understanding of and expertise with clinical operations, data management, safety monitoring, clinical documentation and reporting, and contracting and management of multi-site studies with clinical partners.
Demonstrated ability to lead cross-functional clinical teams with strong people-management, mentoring, and team-building skills.
Outstanding written and verbal communication skills with the ability to engage and educate KOLs, patients, and external stakeholders.
Strategic thinker with proven experience aligning clinical strategy to business and commercial goals, including regulatory and market access objectives; experience synthesizing insights from KOLs and scientific advisors into actionable clinical roadmaps.
Experience in a fast-moving medtech startup, preferably with knowledge of the pharmaceutical ecosystem.
Willingness to travel (domestically and internationally) as needed for clinical site visits, investigator meetings, conferences, company partners, and KOLs.
Physically located near the Twin Cities in Minnesota or is able to frequently travel to Minnesota to work closely with team members of the company.
Applicants must be currently authorized to work in the United States on a full-time basis.
Local applicants or those who can report to work on a frequent basis in Saint Paul, Minnesota during normal work hours and as needed to meet business requirements are encouraged to apply.

Responsibilities

Provide vision, leadership, and operational management and reporting for all clinical programs of the company.
Ensure studies are scientifically rigorous, compliant with regulatory requirements and high ethical standards, and aligned with business and patient-focused objectives.
Lead and mentor a growing clinical team involved with clinical trials and operations, medical affairs, writing of clinical study documents and manuscripts, and supporting national and international regulatory processes.
Serve as the company’s primary clinical liaison to external stakeholders, including key opinion leaders (KOLs), study investigators, CROs, regulatory agencies, reimbursement experts, and clinical partners.
Be responsible for the design, execution, monitoring, data management/analysis, and interpretation of trials that define the safety, efficacy, and clinical utility of SecondWave’s platform.
Partner closely with engineering, regulatory, and commercial teams to translate clinical insights into actionable strategies that guide product development, regulatory submissions, reimbursement strategy, and commercialization.
Work closely with the finance team to manage clinical budgets, resource planning, and forecasting.
Balance strategic vision with hands-on execution.
Further define SecondWave’s clinical footprint.
Influence the development of first-in-class technology.
Play a pivotal role in delivering meaningful outcomes to patients.