Chief Medical Officer

RDI is at an exciting stage of growth. We are a diagnostics-focused CRO supporting complex IVD clinical trials for leading diagnostic companies. We have built a strong operational and laboratory foundation and are now expanding our executive team to further elevate the scientific and medical leadership of the organization.

We are seeking a Chief Medical Officer who will serve as the senior medical and scientific authority for the company. This opportunity may be structured as Fractional or Full-Time, depending on the candidate’s experience and alignment.

This role is strategic, client-facing, and industry-facing. It is not a laboratory management position. It is not a project management role. It is about scientific integrity, regulatory credibility, and guiding the medical direction of our trials.

If you are someone clients turn to when the question is “What is the right scientific approach?” this may be the role for you.

Key Responsibilities

Principal Investigator & Medical Oversight

• Serve as Principal Investigator for IVD validation trials
• Provide medical oversight across national physician study sites
• Ensure scientific integrity and regulatory compliance across all trials
• Review and approve protocols, study designs, and validation strategies
• Guide inclusion and exclusion criteria, endpoints, and clinical relevance

Regulatory & Scientific Leadership

• Act as senior medical signatory where applicable
• Interface with regulatory bodies including FDA as required
• Ensure alignment with CLIA, CAP, GCP, and ICH standards
• Provide high-level scientific review of assay validation and companion diagnostic strategies
• Support inspection readiness and regulatory positioning

Commercial & Strategic Partnership

• Participate in sponsor calls as scientific expert
• Support business development efforts by shaping scientifically sound proposals
• Help convert complex RFPs into executable programs
• Advise on feasibility, risk, and differentiation strategy
• Identify trends in diagnostics and precision medicine that influence company growth

Industry Presence

• Represent the company at scientific and industry conferences
• Contribute to whitepapers and thought leadership initiatives
• Build relationships with key opinion leaders and academic institutions
• Strengthen the company’s reputation as a diagnostics-first scientific partner

What This Role Is Not

• Not responsible for day-to-day laboratory operations
• Not responsible for lab staffing or workflow management
• Not responsible for operational project execution
• Not responsible for managing routine trial logistics

This position focuses on scientific governance, medical credibility, and strategic growth.

What Success Looks Like

• Elevated scientific reputation within the diagnostics CRO space
• Stronger conversion of high-complexity IVD programs
• Clear medical governance across all trials
• Clean regulatory inspections and strong compliance positioning
• Increased visibility through scientific publications and conference participation
• Clients view the company as a true scientific partner

• MD required
• Strong experience in In Vitro Diagnostics
• Experience serving as Principal Investigator in clinical validation studies
• Deep knowledge of assay validation and clinical study design
• CRO and diagnostics experience required
• Experience interacting with FDA and regulatory agencies
• Familiarity with CLIA high-complexity laboratories
• California experience preferred
• On-site presence strongly preferred