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SecondWave Systems, Inc. · 17 hours ago

Vice President of Clinical Affairs

Saint Paul, MN

Full-time

Onsite

Director/Executive

$200K/yr - $260K/yr

15+ years exp

SecondWave Systems is revolutionizing treatment of inflammatory disease through their novel noninvasive ultrasound platform. The Vice President of Clinical Affairs will lead all clinical programs, ensuring scientific rigor and compliance, while mentoring a clinical team and liaising with external stakeholders to drive the company's mission forward.

Health Care

No H1B

Responsibilities

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

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

Design, execute, monitor, 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

Qualification

Clinical development experienceRegulatory submissionsClinical trials designData managementLeadership skillsTeam-building skillsCommunication skillsStrategic thinkingMentoring skills

Required

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