Associate Director, Clinical Diagnostics

Job description

This role provides an exciting opportunity to lead projects across diverse therapeutic areas. As the Associate Director, Clinical Diagnostics (CDx), you will own the end-to-end strategy, development, and lifecycle management of companion diagnostic solutions that enable our therapeutics. This role drives cross-functional alignment across biomarker science, clinical development, regulatory, commercial, and external IVD partners to deliver fit-for-purpose assays that meet global regulatory requirements and support clinical decision-making. You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality diagnostics aligned with drug development milestones. A typical day might include: 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,...