Director, CDx Regulatory Consultant

📋 Description

• Serve as a senior CDx regulatory subject matter expert, advising clients on regulatory positioning
• Assess therapeutic programs, biomarker strategies, intended-use populations, assay technologies
• Lead consulting engagements and develop global CDx regulatory strategies, integrated development
• Develop integrated Rx-Dx strategies that align diagnostic development, biomarker planning, clinical
• Advise on the regulatory use of assays in clinical trials, including patient selection, inclusion
• Direct preparation of regulatory submissions and supporting documentation, including FDA

🎯 Requirements

• Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine
• At least 5 years of consulting experience focused on IVD, companion diagnostics, clinical trial
• At least 7 years of experience in an IVD, companion diagnostic, pharmaceutical, or regulatory
• Direct experience working with diagnostic manufacturers, laboratories, and pharmaceutical sponsors
• Strong understanding of FDA, EU IVDR, and international regulatory pathways applicable to companion
• Demonstrated ability to interpret biomarker, assay validation, clinical performance, and diagnostic

🎁 Benefits

• Opportunity to work on complex companion diagnostic, IVD, and precision medicine programs.
• Senior-level exposure to pharmaceutical, biotechnology, diagnostic, laboratory, and regulatory
• Broad involvement across CDx development, clinical trial enablement, regulatory submissions
• Opportunities to lead multidisciplinary consulting engagements and shape global regulatory
• Leadership and mentorship opportunities within a specialized regulatory consulting environment.
• Exposure to evolving FDA, EU IVDR, and international regulatory frameworks and precision medicine