Remote Senior Manager, Clinical Diagnostics & CDx Strategy

Regeneron Pharmaceuticals, Inc; United States; Remote; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics (CDx) strategy across therapeutic indications.

You will translate scientific needs into fit-for-purpose assays and own programs from feasibility through validation, registration, launch, and post-market sustainment. You will partner with biomarker, clinical, regulatory, commercial, and IVD collaborators while ensuring global submissions and quality compliance.

Qualifications

• PhD in molecular biology, pathology, biomedical engineering, or equivalent.
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations.
• Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions.
• Expertise in NGS, PCR, IHC, and immunoassays, along with validation standards and quality systems.

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

Leadership

Communication

Stakeholder management

CDx strategy

Education

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

Tools

NGS

PCR

IHC

Immunoassays

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Diagnostics to lead end-to-end companion diagnostics (CDx) strategy across therapeutic indications.

You will translate scientific needs into fit-for-purpose assays and own programs from feasibility through validation, registration, launch, and post-market sustainment. You will partner with biomarker, clinical, regulatory, commercial, and IVD collaborators while ensuring global submissions and quality compliance.