Associate Director, Precision Medicine; Clinical Diagnostics

Build our future together:

Were 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. Youll 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 transfer manufacturing readiness and launch preparation with commercial and medical affairs.

This role requires:

• PhD or advanced degree in molecular biology pathology biomedical engineering or related translational/biomedical science field.

• 8 years in diagnostics or translational research with 4 years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.

• Track record translating biomarker science into validated assays supporting drug approvals.

• Working knowledge of global CDx regulatory pathways (FDA CDRH EU IVDR PMDA).

• Ability to translate complex scientific and clinical data for cross-functional and executive audiences.

• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law.

Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role:…