Define assay intent and contribute to target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays); drive analytical validation (accuracy, precision, sensitivity, specificity, LoD, reproducibility) and clinical validation linking performance to benefit-risk. As a Senior Manager, a typical day may include: Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines for seamless program delivery.