Consultant – InVitro Diagnostic Clinical Evaluation

IAVI Inc.

Seeking a highly motivated medical professional with an MD in Microbiology to support the clinical evaluation of high-quality diagnostic solutions for priority diseases. The Consultant will play a critical role in understanding disease patterns and treatment protocols, defining user needs, outlining clinical practices and strengthening clinical evidence generation to advance diagnostic products from concept to clinical validation. The role requires a strong understanding of end-to-end in-vitro diagnostics (IVDs) evaluation frameworks, national/international regulatory pathways and all medical compliances. Working closely with clinical investigators and national stakeholders, the Consultant will support the validation of diagnostics, promote quality systems, and contribute to the development of evidence-based recommendations to guide decision-making in collaboration with laboratories, clinical sites, and industry partners. This position is ideal for a detail-oriented professional who combines scientific rigor with strong operational, communication, and management skills. Key Responsibilities Support the clinical evaluation of in-vitro diagnostics (IVDs) for priority diseases, including development of clinical strategies, study designs, protocols, and performance evaluation plans across the product lifecycle. Generate and strengthen clinical evidence by assessing disease epidemiology, diagnostic pathways, treatment protocols, and user needs to inform target product profiles (TPPs), clinical endpoints, and intended use claims. Contribute to statistical planning, data analysis, and clinical study reporting, ensuring high-quality evidence generation for product refinement. Ensure compliance with national and international regulatory, ethical, and medical standards, and support preparation of submissions to ethics committees and regulatory authorities. Collaborate with laboratories and clinical centers to strengthen quality processes, biosafety, and diagnostic capability through on-site assessments and technical support. Support the development and use of national reference materials for clinical evaluations, including specimen panels. Organize and deliver capacity-building sessions for clinical investigators, laboratory personnel, and industry partners on clinical evaluation of IVDs. Perform any additional tasks to support program objectives Job Type: Contractual / Temporary Contract length: 12-36 months Pay: ₹1,500,000.00 - ₹2,500,000.00 per year Application Question(s): Have you worked with SPSS/STATA/Python/R? Do you have a proficient understanding of clinical workflows, and diagnostic test interpretation? Do you have experience in clinical evaluation of In-vitro Diagnostics (IVD), and understanding of IVD regulatory pathways, including familiarity with ISO 15189, ISO 20916, and CDSCO requirements? Experience: Post-MD exp in trials or diagnostic validation: 3 years (Required) License/Certification: MD in Microbiology or an equivalent PG in Microbiology? (Required) Work Location: In person