Regeneron
Senior Director, Clinical Diagnostics and Precision Medicine
Remote - United States · Director
Sponsorship not specified$242k-$403kDetected 3 days ago
AccountingClinical TrialsFDA RegulatoryPCRMolecular BiologyNGSExperimental DesignLeadershipMentoringBiostatisticsRegulatory Affairs
Stay score
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 biomarker biology, mechanism-of-action hypotheses, clinical utility considerations into diagnostic target product profiles across relevant platforms, including NGS, PCR, immunohistochemistry, immunoassays, and emerging technologies.
- Define assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle planning.
- Accountable for operational readiness of CDx testing in clinical trials, including study startup, laboratory workflows, sample management, data transfer, and quality oversight.
Responsibilities
- Experience managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, timeline-sensitive programs.
- Proven people leadership, including mentoring talent, building capability, and setting priorities in a collaborative, accountable team environment.
Requirements
- Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline.
- 12 or more years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharma, biotech, or diagnostics, including progressive leadership responsibility.
Skills
- Build Our Future Together
- When & where:
- Work model/flexibility:
Compensation
- Where necessary, we disclose salary ranges for roles in all countries in which we operate.
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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This listing is sourced directly from Regeneron's careers page and normalized into a canonical job model.