Vice President of Clinical Affairs

THE OPPORTUNITY: Vice President of Clinical Affairs, Full Time THE COMPANY: At Second. Wave Systems, we have developed a novel noninvasive approach to treat rheumatoid arthritis and other chronic and acute inflammatory disorders. Our Second. Wave 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.

Second. Wave 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. GENERAL DESCRIPTION AND DUTIES: We are seeking a highly experienced and strategic clinical executive to join Second. Wave 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 Second. Wave’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 Second. Wave’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.

PHYSICAL DEMANDS: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may enable individuals with disabilities to perform the essential functions. The incumbent typically works in an office/light manufacturing environment and uses a computer, telephone and other office/light manufacturing equipment as needed to perform duties.

The noise level in the work environment is typical of that of an office. Incumbent may encounter frequent interruptions throughout the workday. The employee is regularly required to sit, talk, or hear, and is frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 50 pounds.

This job requires travel by air, train, and car travel, sometimes for long distances and extended periods of time especially during periods of high clinical activity across multiple study sites. PAY AND BENEFITS: Pay Range: $200,000-260,000 base salary; depending on qualifications/experience; Equity compensation to be provided FLSA Status: Full Time Exempt Second.

Wave Systems offers a comprehensive benefits package that includes: Medical, dental, and vision insurance Short- and long-term disability insurance Employee Assistance Program Company paid and Voluntary Life insurance Aflac Paid company holidays Vacation and sick time SIMPLE IRA with 3% company match Opportunities for advancement TO APPLY: Apply via our Careers site.

Check us out at www.secondwaveus.com If you are in growth-mode and you are seeking the next big challenge to advance your career, we hope to hear from you! Tell us why you are interested in this position and your desired salary in your cover letter. Include your resume, answer a few questions, then click submit. This position will remain open until filled.

Applicants must be currently authorized to work in the United States on a full-time basis. This company does not sponsor applicants for work visas. 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.

EOE/Minorities/Females/Vet/Disability. Second. Wave Systems reserves the right to alter, change, modify and/or terminate this job posting at any time without advance notice, or obligation, to any party. No agencies, please. Notice to Recruiters/Staffing Agencies: Recruiters and staffing agencies should not contact Second.

Wave Systems through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Second.

Wave Systems’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Second. Wave Systems and such organization and will be considered unsolicited and Second. Wave Systems will not be responsible for related fees.

Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Second. Wave Systems, HR only direct candidates to apply through our official career page at https://jobs.gusto.com/boards/secondwave-systems-inc-667f45be-fd34-4f40-aef2-b2c864294d53 and HR will always contact you using the domain of secondwaveus.

com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Second. Wave Systems, please act with caution. Salary $200,000 - $260,000 per year