Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Regeneron Pharmaceuticals•Warren, MI

1d•Onsite

About The Position

As Senior Manager, Clinical Diagnostics, you will support end-to-end CDx strategy and execution to enable therapeutics across indications. Partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators, you will translate scientific needs into fit-for-purpose assays for global decisions. You will own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment, ensuring timelines, quality, and budgets aligned to drug milestones. This role combines hands-on leadership, vendor management, and cross-functional orchestration under quality and regulatory frameworks. You will serve as a governance interface and refine CDx strategy.

Requirements

Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
4+ years in diagnostics development
2+ years leading CDx/IVD in pharma or diagnostics organizations.
Proven delivery of CDx aligned to drug approvals; successful validation and regulatory submissions.
Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.
Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
Strong grasp of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.
Excellent communication, leadership, and stakeholder management; clear, concise updates to executive audiences.
Strategic translation of scientific and clinical needs into executable diagnostics under QMS/GxP.

Nice To Haves

You thrive in a fast-paced environment
You are detail oriented, well-organized and can multi-task
You are a team player
You have strong communication skills

Responsibilities

Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines for seamless program delivery.
Lead cross-functional teams; integrate workstreams, clear obstacles, and provide transparent, regular status reporting to governance bodies and senior leadership.
Manage IVD partners—negotiate scope, timelines, budgets, and quality; oversee co-development, Joint Steering Committees, and performance.
Define assay intent and contribute to target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays); drive analytical validation (accuracy, precision, sensitivity, specificity, LoD, reproducibility) and clinical validation linking performance to benefit–risk.
Embed CDx assays in trials with clinical teams—screening/stratification, sampling, site readiness, and lab operations for reliable execution.
Partner with IVD Regulatory on global submissions—FDA PMA/supplements, 510(k) as applicable, EU IVDR, PMDA; support pre-subs, labeling, and responses.
Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management.
Oversee design transfer, manufacturing readiness, and supply; support launch readiness with Commercial/Medical teams.