Regeneron
Associate Director Precision Medicine - Clinical Diagnostics
Remote - United States · Director
Sponsorship not specified$176k-$287kDetected 2 days ago
GCPFDA RegulatoryPCRMolecular BiologyNGSMedical DevicesResearchCollaborationGxP
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odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles, defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
Responsibilities
- 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 companion diagnostic 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.
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- 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.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.
Requirements
- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
Compensation
- Where necessary, we disclose salary ranges for roles in all countries in which we operate.
Benefits
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.
Company info
- Please be advised that at Regeneron, we believe we do our best work when we are together.
- As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based.
Visa & Work Authorization
- ignment, 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
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