Vice President of Clinical Research Development

Vascular Breakthroughs; Burlington (MA); Presencial; USD 140.000 - 200.000; Jornada completa

Descripción de la vacante

Vascular Breakthroughs in Burlington, MA seeks a Vice President of Clinical Research Development to build and scale a national SMO/CRO for device trials. You will partner with executive leadership to design scalable, compliant multi-site operations and expand the trial portfolio with hospitals, health systems, and investigators.

The role requires a proven leader with CRO/SMO experience, an entrepreneurial mindset, and excellence in relationship management, regulatory oversight, and strategic

Formación

• 10+ years of experience in business leadership, including at least 5 years in leadership roles within a CRO, SMO, or sponsor-side research operations.
• Deep understanding of device trial operations, ideally with vascular/interventional device experience.
• Entrepreneurial mindset with ability to thrive in a growth-stage organization.
• Exceptional relationship management, communication, and operational strategy skills.

Responsabilidades

• Design and execute a strategy to evolve the current OBL-based research program into a full-scale SMO/CRO.
• Define organizational structure, processes, and governance for scalable, compliant multi-site operations.
• Build partnerships with hospitals, physician groups, device manufacturers, and early-stage device companies.
• Lead site identification, activation, contracting, budgeting, and planning across hospital systems and external sites.
• Mature the functional architecture (clinical ops, regulatory, data, monitoring, QA, vendor mgmt).
• Advance centralized operations for data management and regulatory oversight.
• Identify and onboard additional research sites and investigators beyond current footprint.
• Develop relationships with sponsors/CROs and build the commercial model and growth strategy for the new unit.
• Represent capabilities at conferences and industry forums.
• Lead diversification into adjacent device categories while maintaining device-trial focus.
• Recruit, mentor, and develop clinical research and operations teams.
• Foster a culture of scientific integrity, regulatory compliance, and operational excellence.

Conocimientos

Leadership

Strategic planning

Partnership development

Regulatory compliance

Operations management

Multi-site management

Stakeholder management

Descripción del empleo

Vice President of Clinical Research Development

Burlington, MA

About the Opportunity

Vascular Breakthroughs is seeking a dynamic and entrepreneurial executive to build and scale our existing clinical trials business. Our current clinical research operations are embedded within eight Office-Based Laboratories (OBLs) and focus exclusively on vascular device trials. This role represents a unique opportunity to expand that platform-both geographically and across new clinical areas-by establishing a broader infrastructure and network capable of managing device-based trials in partnership with hospitals, health systems, and external investigators. The role will work closely with executive leadership, physician leadership, and current clinical trials leadership, including the Vice President of Clinical Operations and Executive Chairman.

Key Responsibilities

Strategic Development & Leadership

• Design and execute a comprehensive strategy to evolve the current OBL-based research program into a full-scale SMO/CRO.
• Define organizational structure, processes, and governance to support scalable, compliant, and efficient multi-site operations.
• Build partnerships with hospital systems, physician groups, device manufacturers, and early-stage device companies to broaden the trial portfolio.

Operational Expansion

• Lead site identification, activation, contracting, budgeting, and strategic planning across hospital systems, outpatient centers, and external investigator sites.
• Mature the existing functional architecture (clinical operations, regulatory, data, monitoring, site management, quality assurance, vendor management, etc.).
• Advance centralized operations for data management, monitoring, and regulatory oversight.
• Identify and onboard additional research sites and investigators beyond Vascular Breakthroughs' current footprint.

Business Development

• Develop relationships with sponsors and CROs seeking high-quality, device-focused research sites.
• Build the commercial model, pricing structure, and growth strategy for the new SMO/CRO business unit.
• Represent Vascular Breakthroughs' research capabilities at conferences, advisory boards, and industry partnership forums.

Cross-Specialty & Device Trial Expansion

• Lead efforts to diversify research beyond vascular interventions into adjacent procedural or surgical device categories.
• Maintain focus on device trials while leveraging existing operational efficiency and physician expertise in outpatient procedural care.

Leadership & Culture

• Recruit, mentor, and develop clinical research and operations teams.
• Foster a culture of scientific integrity, regulatory compliance, and operational excellence.

Qualifications

• 10+ years of experience in business leadership, including at least 5 years (preferred) in leadership roles within a CRO, SMO, or sponsor-side research operations.
• Deep understanding of device trial operations, ideally with experience in vascular, endovascular, interventional radiology, or related device areas.
• Experience managing clinical partnerships across outpatient centers, hospitals, and integrated health systems.
• Entrepreneurial mindset and ability to thrive in a growth-stage organization.
• Exceptional relationship management, communication, and operational strategy skills.

Why Join Us

• Lead the transformation of an established clinical research arm into a national-level SMO.
• Build on a strong foundation of eight OBL-based research sites and a proven vascular device research program with established scientists and investigators.
• Collaborate with top-tier vascular specialists and a data-driven management team focused on innovation and patient outcomes.
• Competitive compensation, performance incentives, and the opportunity to shape a new business line from the ground up.

*Please note that this role is expected to commute to the Burlington, MA office at least once a week*

Compensation

$140,000 - $200,000 per year. Negotiable based on skills and experience.