Senior Director, IVD Development — cfDNA/NGS (Remote)

Natera; United States; Remote; USD 268,000 - 335,000; Full time

Benefits offered by this job

Competitive benefits

Free testing for employees and depend

Job summary

Natera is seeking a Senior Director of Development to lead the ECD and MCED diagnostic portfolio. You will own strategy and execution for NGS cfDNA IVD products from feasibility to regulatory approval, building and guiding a scientific team and partnering with FDA and executive leadership.

You will drive multi-year plans, oversee phase-gated development, and ensure robust analytical validation and manufacturing transfer, while aligning with cross-functional teams and QMS requirements.

Qualifications

• PhD, MD or equivalent in life sciences or related field.
• 7+ years in IVD or diagnostic device development under design controls.
• 7+ years directing scientific/technical organizations, 5+ years managing senior managers.

Responsibilities

• Define multi-year assay development strategy for ECD/MCED portfolio.
• Oversee design verification, validation of NGS cfDNA IVD devices.
• Set priorities, budget, and resources; advise exec leadership.
• Establish analytical verification/validation to enable manufacturing transfer.
• Support pivotal/prospective study design and analyses with clinical leaders.
• Define regulatory pathways for PMA submissions and FDA interactions.
• Build and mentor leadership team; optimize budget and partnerships.
• Collaborate across functions to deliver regulation-compliant IVD products.
• Communicate portfolio status and tradeoffs to executives.
• Ensure QMS compliance and audit readiness with Quality.

Skills

NGS diagnostics

cfDNA analysis

Regulatory strategy

Cross-functional leadership

Data-driven decisions

FDA interactions

Analytical verification

Project prioritization

Strategic thinking

Education

Advanced degree in Molecular Biology / Biomedical Engineering

Job description

Natera is seeking a Senior Director of Development to lead the ECD and MCED diagnostic portfolio. You will own strategy and execution for NGS cfDNA IVD products from feasibility to regulatory approval, building and guiding a scientific team and partnering with FDA and executive leadership.

You will drive multi-year plans, oversee phase-gated development, and ensure robust analytical validation and manufacturing transfer, while aligning with cross-functional teams and QMS requirements.