At a Glance
- Tasks: Lead companion diagnostic strategy from biomarker feasibility to clinical validation and launch.
- Company: Join a pioneering company at the forefront of precision medicine.
- Benefits: Enjoy competitive salary, bonuses, equity awards, and health benefits.
- Other info: Dynamic role with opportunities for career growth and collaboration across global teams.
- Why this job: Make a real impact by translating biology into validated assays that guide drug development.
- Qualifications: 8+ years in diagnostics with a PhD or advanced degree in a relevant field.
The predicted salary is between 75600 - 92400 £ per year.
In this role you will lead companion diagnostic (CDx) strategy from biomarker feasibility to clinical validation and launch, aligning translational science with diagnostic execution. You will bridge biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones. You will shape diagnostic target product profiles, oversee multi-platform assay development, and drive global regulatory and launch readiness. This is a high-impact opportunity to translate biology into validated assays that guide drug development decisions and patient stratification.
Key Responsibilities:
- Translate biomarker and mechanism data into diagnostic target product profiles and define assay intent across platforms (NGS, PCR, IHC, immunoassays).
- Design biomarker strategies for patient selection, stratification, and enrichment including sample strategy and logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, LOD, reproducibility) and link assay performance to safety and efficacy endpoints.
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Select and oversee IVD development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (FDA PMA/supplement, EU IVDR, PMDA) with labeling alignment.
- Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment.
- Lead cross-functional working groups and translate scientific rationale into program plans and governance reporting.
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.
Qualifications:
- 8+ years in diagnostics or translational research.
- 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
- Track record translating biomarker science into validated assays.
- Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
- Ability to translate complex scientific data for cross-functional/executive audiences.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.
- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field.
Associate Director, Precision Medicine (Clinical Diagnostics) employer: Regeneron Pharmaceuticals, Inc
At Regeneron, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters innovation and collaboration. As a Senior Manager in our Global Development Quality Assurance team, you will have the opportunity to lead impactful audit strategies while working remotely from the UK or Ireland, benefiting from a comprehensive rewards package that includes competitive bonuses, health and wellness programs, and robust employee growth opportunities. Join us in making a meaningful difference in patients' lives while enjoying a supportive environment that values diversity and professional development.
Contact Details:
Regeneron Pharmaceuticals, Inc Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Precision Medicine (Clinical Diagnostics)
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We think you need these skills to ace Associate Director, Precision Medicine (Clinical Diagnostics)
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