Associate Director, Precision Medicine (Clinical Diagnostics)
About the role
Build Our Future Together We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external In Vitro Diagnostic (IVD) partners to ensure diagnostics keep pace with therapeutic milestones. Location: Dublin, Ireland (multiple locations are being considered for this role.) Work model/flexibility: 3 days onsite.
Responsibilities
- Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
- Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLS