Work closely with Clinical Development, Medical, Regulatory, Quality, R&D, Biostatistics, Laboratory Operations, Finance, and Commercial teams to align execution with clinical and business objectives Work closely In collaboration with Regulatory and Quality, support ethics and regulatory submissions, clinical performance evidence, GCP compliance, audit readiness, and responses to agency or ethics committee questions; regulatory submission ownership is not the primary focus of this role Establish concise portfolio-level reporting for leadership on enrollment, site activation, specimen success, data quality, milestone delivery, spend, and key risks; build and mentor the clinical operations function as the portfolio grows. Experience managing global clinical studies and partnering with international CROs, ethics committees, and central laboratories and knowledge of regulatory aspects concerning human subject research Experience in diagnostic, IVD, medical device, companion diagnostic, or biomarker-driven clinical development, particularly clinical performance studies Experience building clinical operations infrastructure Familiarity with device/IVD regulatory and quality frameworks, as applicable, such as ISO 20916, ISO 13485, the FDA QMSR (21 CFR Part 820), U.S. FDA diagnostic pathways, EU IVDR, and India CDSCO requirements.