Senior CDx Program Lead, Remote Diagnostics Strategy

Regeneron Pharmaceuticals

Oregon

Ibrido

USD 151.000 - 246.000

Tempo pieno

10 giorni fa

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Descrizione del lavoro

Regeneron Pharmaceuticals, Inc is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end CDx strategy across therapeutic areas. You will translate scientific needs into fit-for-purpose assays and own programs from feasibility to validation and launch, partnering with biomarker, clinical, regulatory, and IVD teams.

Requirements include a PhD and 4+ years in diagnostics development, with 2+ years leading CDx/IVD programs.

Competenze

PhD in molecular biology, pathology, biomedical engineering, or equivalent.
4+ years in diagnostics development, incl. 2+ years leading CDx/IVD programs.
Delivery of CDx aligned to drug approvals with regulatory submissions.
Expertise in NGS, PCR, IHC and immunoassays and related validation.

Mansioni

Execute end-to-end CDx strategy aligning with clinical development timelines.
Lead cross-functional teams and report status to senior leadership.
Manage IVD partners including scope, timelines, budgets, and quality.
Define assay intent and contribute to target product profiles for CDx platforms.
Embed CDx assays in trials covering screening, sampling, and lab readiness.
Partner with IVD Regulatory on global submissions and labeling.