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 IVD partners to ensure diagnostics keep pace with therapeutic milestones.
When & where
Location: Uxbridge, United Kingdom (multiple locations are being considered for this role.)
Work model/flexibility: 3 days onsite
Discover your role
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, CLSI, IVDR, GCP alignment).
Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
Support design
Associate Director, Precision Medicine (Clinical Diagnostics) in London employer: Regeneron Pharmaceuticals, Inc
At Regeneron, we pride ourselves on being a science-driven organisation that is dedicated to making a meaningful difference in patients' lives. As a Director of International Commercialization Immunology based in Uxbridge, UK, you will thrive in a collaborative and inclusive work culture that values innovation and employee growth. With competitive benefits, including health and wellness programmes, and opportunities for professional development, Regeneron is an excellent employer for those looking to contribute to impactful healthcare solutions while enjoying a supportive work environment.
Contact Details:
Regeneron Pharmaceuticals, Inc Recruitment Team
