Director of Clinical Programs

Description

We are seeking a strategic and hands-on Director of Clinical Programs to lead the execution of our clinical initiatives supporting AI-driven medical device platforms. This role will oversee multi-site clinical studies, including government-funded programs (e.g., BARDA), and drive clinical evidence generation aligned with regulatory, reimbursement, and commercial objectives.

The Director will work cross-functionally to ensure clinical programs are executed efficiently and generate high-quality data that supports product development, market access, and adoption.

Key Responsibilities

Clinical Program Leadership

• Lead the planning and execution of multi-site clinical studies for AI training and validation. 
• Manage government-funded clinical programs (e.g., BARDA), ensuring compliance, reporting, and milestone achievement. 
• Oversee investigator-initiated research (IIR) programs supporting next-generation platforms. 
• Ensure all clinical programs are delivered on time, within scope, and within budget. 

Clinical Strategy & Evidence Generation

• Contribute to the development of clinical evidence strategies supporting regulatory and reimbursement pathways. 
• Align clinical study designs with product development and commercialization goals. 
• Support the generation of data to demonstrate clinical utility, safety, and performance. 

Study Operations & Site Management

• Oversee site identification, initiation, monitoring, and close-out activities. 
• Track enrollment performance and implement strategies to optimize site productivity. 
• Manage CROs, vendors, and subcontractors, ensuring high-quality execution. 
• Ensure compliance with study protocols, GCP, and applicable regulations. 

Clinical Program Management & Execution

• Proactively track timelines, budgets, risks, and deliverables across clinical programs. 
• Coordinate clinical activities against program milestones and reporting requirements. 
• Prepare and deliver regular clinical status updates to internal and external stakeholders including government sponsors
• Maintain accurate documentation and reporting infrastructure, including risk management.

Cross-Functional Collaboration

• Partner with R&D, product, regulatory, commercial, and manufacturing teams to align clinical activities with broader company objectives. 
• Provide clinical insights to inform product design, usability, and product-market fit. 
• Support clinical aspects of market expansion and customer engagement initiatives such as market research product discussions with physicians.

Reimbursement & Market Access Support

• Support clinical inputs into reimbursement strategies and evidence requirements. 
• Collaborate with internal stakeholders to ensure clinical data supports payer and health system adoption. 

KOL & External Engagement

• Establish and maintain relationships with investigators and key opinion leaders (KOLs). 
• Support KOL engagement strategies and participation in medical society activities. 
• Contribute to external clinical and scientific communications. 

Governance & Vendor Management

• Manage CROs, Medical Advisory Committees, and other external partners. 
• Ensure effective communication and coordination across all stakeholders. 
• Support oversight of clinical governance structures and advisory groups. 

Requirements

• Advanced degree (MD, PhD, PharmD, or MS with relevant experience) 
• 7–10+ years of experience in clinical research, clinical operations, or clinical development in Medtech, digital health, or related field 
• Experience managing multi-site clinical studies 
• Strong program management skills with the ability to manage timelines, budgets, and vendors 
• Experience working cross-functionally in a product-driven environment 

Preferred

• Experience with AI/ML-enabled medical devices or imaging technologies 
• Experience with government-funded programs (e.g., BARDA, NIH, DoD) 
• Familiarity with reimbursement and evidence requirements for market access 
• Experience engaging with KOLs and managing investigator relationships 

Key Competencies

• Strong execution and operational leadership 
• Strategic thinking with attention to detail 
• Cross-functional collaboration and influence 
• Stakeholder and vendor management 
• Excellent communication and organizational skills 
• Ability to thrive in fast-paced, evolving environments 

Impact of the Role

This role is critical to the successful execution of our clinical programs and the generation of evidence needed to support regulatory clearance, reimbursement, and market adoption of our AI-based medical technologies.

About Rivanna Medical, Inc.: Rivanna Medical, Inc. is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. Rivanna Medical, Inc. operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures. Rivanna Medical, Inc.'s revolutionary platforms feature BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.

Employee Benefits at Rivanna Medical, Inc.: Rivanna Medical, Inc. offers a comprehensive benefits package, which includes health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

Equal Employment Opportunity Statement: Rivanna Medical, Inc. is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.