Senior Director, Development — NGS cfDNA IVD Strategy

Natera; San Carlos (CA); Remote; USD 268,000 - 335,000; Full time

Job summary

Natera is seeking a Senior Director of Development to lead the ECD and MCED portfolio, guiding NGS and cfDNA IVD products from feasibility to PMA and post-market support. Build and mentor a leadership team and represent development with FDA and executive leadership.

The role requires an advanced degree in a related field and 7+ years in IVD or diagnostic device development, with a strong track record in FDA interactions and PMA submissions. Remote USA opportunity with competitive compensation.

Qualifications

• Advanced degree in Molecular Biology, Biomedical Engineering, Life Sciences or related field.
• 7+ years in IVD or diagnostic device development under design controls.
• 7+ years directing scientific/technical organizations with 5+ years mentoring senior managers or directors.

Responsibilities

• Define multi-year assay development strategy and lifecycle for ECD and MCED portfolios.
• Oversee phase-gated execution of programs including design verification and validation of cfDNA/NCS-based devices.
• Allocate budget, personnel, and lab resources; advise go/no-go decisions to executives.
• Establish analytical verification/validation strategies for seamless transfer to manufacturing.
• Support pivotal and prospective study design and regulatory evidence for PMA submissions.

Skills

Strategic leadership

Budget/resource management

Cross-functional collaboration

Regulatory strategy

Executive communication

NGS knowledge

cfDNA diagnostics

Program management

Education

PhD / MD or equivalent in Life Sciences or related field

Job description

Natera is seeking a Senior Director of Development to lead the ECD and MCED portfolio, guiding NGS and cfDNA IVD products from feasibility to PMA and post-market support. Build and mentor a leadership team and represent development with FDA and executive leadership.

The role requires an advanced degree in a related field and 7+ years in IVD or diagnostic device development, with a strong track record in FDA interactions and PMA submissions. Remote USA opportunity with competitive compensation.