Director of Clinical Programs

Rivanna Medical, Inc.Charlottesville, VA
2d

About The Position

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.

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

Nice To Haves

  • 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

Responsibilities

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

Benefits

  • 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.
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