Director of Clinical Affairs - Minneapolis - VentureMedGroup, Ltd.

Description

Overview

VentureMed is a fast-growing MedTech innovator advancing vascular and endovascular care. Founded by vascular surgeon Dr. John Pigott, the company developed the FLEX Vessel Prep System, a minimally invasive, non-balloon endovascular tool designed to optimize vessel preparation and improve outcomes in AV fistula, graft, and peripheral interventions. Backed by a seasoned leadership team with multiple MedTech scale-and-exit successes, VentureMed is entering a major commercial growth phase—expanding nationally and building its clinical and reimbursement infrastructure.

Why You'll Love It

• Join an experienced leadership team with deep vascular and endovascular expertise and a proven track record of building and exiting successful MedTech companies.


• Help advance a first-in-class technology with strong clinical evidence, FDA clearance, and active reimbursement momentum through a current TPT designation.


• Play a foundational role in supporting VentureMed's commercial organization—building process, culture, and impact in a company on the rise.

Position Summary

The Director of Clinical Affairs leads the strategic planning, execution, and oversight of clinical research initiatives that support the company's medical device development, regulatory approvals, and commercial objectives. This role ensures clinical trials are conducted in compliance with regulatory requirements, Good Clinical Practices (GCP), and company policies.

This role is not eligible for Immigration sponsorship nor relocation.

Responsibilities

1. Strategic Clinical Program Leadership
   • Develop and execute comprehensive clinical strategies to support regulatory approvals, product development, and market adoption and reimbursement strategies.
   
   
   • Align clinical programs with business priorities in collaboration with R&D, Marketing, Regulatory, and Commercial teams.
   
   
   • Provide strategic input into the design of pivotal and post-market clinical studies to generate safety, efficacy, and health economics evidence.
   
   
   
   


2. Study Design and Protocol Development
   • Lead the design of clinical protocols for IDE, feasibility, pivotal, and post-market studies.
   
   
   • Ensure protocols meet regulatory, scientific, and ethical standards while addressing key business questions.
   
   
   • Collaborate with cross-functional stakeholders and KOLs during protocol development to ensure clinical relevance and feasibility.
   
   
   
   


3. Clinical Operations Oversight
   • Direct the day-to-day execution of clinical trials, including site identification, initiation, patient enrollment, monitoring, and close-out.
   
   
   • Manage internal teams and external vendors (e.g., CROs, consultants, medical writers) to ensure quality execution and data integrity.
   
   
   • Oversee the development and approval of essential trial materials: investigator brochures, CRFs, regulatory binders, ICFs, and training documents.
   
   
   
   


4. Regulatory and Ethical Compliance
   • Ensure all clinical studies are conducted in accordance with appropriate FDA, EMA, ISO, ICH-GCP, and applicable country-specific requirements.
   
   
   • Oversee submissions to IRBs, Ethics Committees, FDA (IDE/IDE Supplements), and other regulatory bodies.
   
   
   • Serve as primary clinical contact for inspections, audits, and regulatory inquiries; support BIMO inspection readiness and response.
   
   
   
   


5. Safety and Risk Management
   • Monitor safety data and ensure timely reporting of adverse events and SAEs to applicable parties.
   
   
   • Interface with medical monitors and safety boards to assess ongoing risk-benefit during clinical trials.
   
   
   • Review and adjudicate safety events; provide clinical input on product complaints and recalls, if applicable.
   
   
   
   


6. Data Management and Analysis
   • Oversee development of data management plans, CRF completion guides, and data validation processes.
   
   
   • Partner with biostatisticians for statistical analysis planning, interim reviews, and final clinical study reports.
   
   
   • Ensure robust data quality and traceability across all clinical deliverables.
   
   
   
   


7. Publication and Dissemination
   • Support the development of peer-reviewed manuscripts, abstracts, and presentations for scientific and medical conferences.
   
   
   
   


8. Cross-functional Collaboration
   • Partner with Marketing to support clinical evidence needs for product launch, reimbursement, and physician education.
   
   
   • Support Regulatory Affairs in the preparation of clinical sections for 510(k), CE mark, and other global submissions.
   
   
   • Collaborate with Quality and R&D on risk management files, human factors testing, and design validation.
   
   
   
   


9. Budget and Resource Management
   • Develop and manage clinical study budgets, contracts, and timelines.
   
   
   • Ensure efficient allocation of internal resources and selection/oversight of qualified CROs and third-party consultants.
   
   
   • Review and approve site payments, milestone-based deliverables, and invoice reconciliation.
   
   
   
   


10. Leadership and Talent Development
    • Build, lead, and mentor a high-performing clinical team whether internal or external members.
    
    
    • Provide direction, coaching, and professional development opportunities for clinical staff.
    
    
    • Foster a culture of accountability, compliance, and continuous improvement.
    
    
    
    


11. Qualifications and Skills
    • 15 + years of related experience with proven track record in execution of clinical studies with medical devices. Must have lead a clinical trial from start to finish.
    
    
    • Demonstrated evidence of leadership, creativity, flexibility, determination and perseverance.
    
    
    • Excellent oral/written communication skills, including group facilitation and presentation skills.