Senior Director, ECD & MCED Development Strategy

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

Benefits offered by this job

Medical, dental, vision insurance

Fertility benefits

401k benefits with employer match

Employee referral program

Job summary

Natera, Inc. is seeking a Senior Director of Development to lead the ECD and MCED portfolio.

You will own strategy and execution for NGS-based cfDNA IVDs, guiding products from feasibility through FDA PMA and post-market support, building and mentoring a high-performing development organization. You will oversee cross-functional teams across regulatory, clinical, biostatistics, and software to deliver rigorous evidence packages, drive portfolio decisions, and ensure QMS compliance in a highly

Qualifications

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or related field.
• 7+ years of experience in IVD or diagnostic device development under design controls.
• 7+ years of experience directing scientific or technical organizations, with 5+ years managing senior managers or directors.

Responsibilities

• Define and own the multi-year assay development strategy and technical lifecycle for the ECD and MCED portfolio.
• Oversee phase-gated execution of all ECD and MCED programs, including design verification and validation for cfDNA/NGS-based IVDs.
• Set priorities, allocate people, budget, and labs resources; guide go/no-go decisions to leadership.
• Establish analytical verification/validation strategy to ensure transfer to manufacturing.
• Partner with clinical/biostatistics to support pivotal study design and performance claims.
• Define regulatory pathways for PMA submissions and engage with FDA at senior levels.

Skills

Tech leadership

Program management

Regulatory strategy

NGS-based IVD

Cross-functional collaboration

FDA interactions

Data-driven decisions

Education

PhD/MD or equivalent

Job description

Natera, Inc. is seeking a Senior Director of Development to lead the ECD and MCED portfolio.

You will own strategy and execution for NGS-based cfDNA IVDs, guiding products from feasibility through FDA PMA and post-market support, building and mentoring a high-performing development organization. You will oversee cross-functional teams across regulatory, clinical, biostatistics, and software to deliver rigorous evidence packages, drive portfolio decisions, and ensure QMS compliance in a highly