Remote Senior Manager, CDx Strategy & Diagnostics

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Paid time off

Equity awards

Job summary

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics (CDx) strategy and execution across therapeutic programs.

You will translate scientific needs into fit-for-purpose assays and own programs from feasibility through validation, registration, launch, and post-market sustainment. The role collaborates with biomarker, clinical, regulatory, commercial, and IVD teams, defines assay intent for platforms like

Qualifications

• PhD in molecular biology, pathology, biomedical engineering, or equivalent.
• 4+ years in diagnostics development.
• 2+ years leading CDx/IVD programs in pharma or diagnostics.
• Proven delivery of CDx aligned to drug approvals; successful validation and regulatory submissions.

Responsibilities

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines.
• Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership.
• Manage IVD partners, negotiating scope, timelines, budgets, and quality, and overseeing co-development and Joint Steering Committees.
• Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), driving analytical and clinical validation.
• Embed CDx assays in trials with clinical teams, covering screening/stratification, sampling, site readiness, and lab operations.
• Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses.
• Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness.
• Thrive in a fast-paced, multi-tasking environment, bringing strong communication skills to cross-functional collaboration.

Skills

CDx strategy

Cross-functional leadership

IVD program management

Regulatory alignment

NGS

PCR

IHC

Immunoassays

Stakeholder management

Executive communication

Education

PhD in molecular biology, pathology, biomedical engineering, or equivalent

Job description

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics (CDx) strategy and execution across therapeutic programs.

You will translate scientific needs into fit-for-purpose assays and own programs from feasibility through validation, registration, launch, and post-market sustainment. The role collaborates with biomarker, clinical, regulatory, commercial, and IVD teams, defines assay intent for platforms like