Senior Manager, Clinical Diagnostics CDx Strategy (Remote)

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 151.000 - 246.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics strategy and execution across therapeutic indications. You will translate scientific needs into fit-for-purpose CDx assays, owning programs from feasibility through validation, registration, launch and post-market sustainment.

You will partner with biomarker, clinical, regulatory, commercial, and IVD teams to drive analytics, validation and global submissions while ensuring

Qualifikationen

• PhD or equivalent in molecular biology, pathology, biomedical engineering, or related field.
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics environments.
• Proven delivery of CDx programs aligned to drug approvals with regulatory experience.
• Expertise in NGS, PCR, IHC, and immunoassays, plus validation standards and quality systems.
• Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling.
• Excellent communication, leadership, and stakeholder management, with ability to present to executives.

Aufgaben

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic timelines.
• Lead cross-functional teams, coordinate workstreams, remove obstacles, and provide clear governance updates.
• Manage IVD partners, negotiating scope, timelines, budgets, and quality oversight.
• Define assay intent and contribute to target product profiles for CDx platforms (NGS, PCR, IHC, immunoassays).
• Embed CDx assays in trials with clinical teams (screening, stratification, sampling, site readiness).
• Collaborate with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA) and labeling.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, GCP, and maintain audit-ready documentation.
• Thrive in a fast-paced, multi-disciplinary environment with strong communication.

Kenntnisse

Leadership

Communication

Stakeholder management

Regulatory knowledge

Ausbildung

PhD in molecular biology or equivalent

Tools

NGS

PCR

IHC

Immunoassays

Jobbeschreibung

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics strategy and execution across therapeutic indications. You will translate scientific needs into fit-for-purpose CDx assays, owning programs from feasibility through validation, registration, launch and post-market sustainment.

You will partner with biomarker, clinical, regulatory, commercial, and IVD teams to drive analytics, validation and global submissions while ensuring