Associate Director, Clinical Diagnostics

Responsibilities Set the global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines for the therapeutic. Lead selection and oversight of IVD partners; negotiate scopes, timelines, budgets, and quality expectations; manage co‑development and governance. Define assay intent and target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, immunoassays), ensuring analytical and clinical performance meets intended use. Partner with biomarker and clinical teams to integrate CDx into trial designs (screening, enrichment, stratification), including sample strategy and operational readiness. Drive analytical validation plans (e.g., accuracy, precision, sensitivity/specificity, LoD, reproducibility) and clinical validation strategies linking assay results to drug safety and efficacy. In collaboration with IVD Regulatory, support global regulatory strategy and submissions for CDx (e.g., FDA PMA/supplement, 510(k) where applicable, EU IVDR, PMDA), including pre‑submission interactions and labeling alignment. Ensure compliance with applicable standards and regulations (e.g., ISO 13485, ISO 14971, CLSI guidelines, IVDR, GCP alignment for diagnostic use in trials). Coordinate cross‑functional working groups, remove program obstacles, and provide transparent status reporting to governance bodies. Oversee design transfer, manufacturing readiness, and supply planning with IVD partners to ensure clinical and commercial availability. Drive risk management and mitigation plans across technical, regulatory, operational, and commercial domains. Partner with commercial and medical affairs to shape CDx launch readiness (access, coverage, distribution, training, KOL engagement). Requirements Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering, or related) or equivalent experience 8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceutical or diagnostics settings #J-18808-Ljbffr