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Senior Director, Development - ECD and MCED Products

Natera· Bio Development
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Remote$268.2k - $335.2kFull-timePosted 5d ago

About the role

Senior Director of Development leading the ECD and MCED portfolio, owning product development strategy and execution for NGS- and cfDNA-based IVDs from feasibility through FDA PMA and post-market support; responsible for building and leading a multi-disciplinary team, engaging with FDA and executive leadership, and ensuring regulatory, scientific, and business objectives are aligned.

Responsibilities

  • Define and own the multi-year assay development strategy and technical lifecycle for the ECD and MCED portfolio, in alignment with corporate and R&D strategy
  • Oversee phase-gated execution of all ECD and MCED programs, including development, design verification, and validation of NGS-based cancer detection IVD devices using cfDNA, methylation, and other analyte classes
  • Set team priorities, allocate people, budget, and laboratory resources, and make or recommend go/no-go decisions to executive leadership
  • Establish the analytical verification and validation strategy for the portfolio to ensure robust assays transfer seamlessly to commercial manufacturing
  • Partner with clinical, medical, and biostatistics leaders to support approvable pivotal and prospective study design, statistical analysis plans, and performance claims for screening-population use
  • Define regulatory pathways and evidence requirements for PMA submissions; represent Development in senior-level FDA engagements and ensure analytical performance data packages
  • Build, retain, and mentor a leadership team of directors, managers, and scientists; optimize budget and vendor partnerships
  • Collaborate across research, bioinformatics, biostatistics, software, clinical, regulatory, and commercial functions to deliver design-controlled IVD products
  • Communicate portfolio status, risks, and tradeoffs to executive leadership; drive enterprise alignment
  • Ensure compliance with Natera QMS and applicable guidance (ISO 13485, FDA QMSR, ISO 14971, IEC 62304) and partner with Quality for audit readiness and design control practices

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

Skills

Required:Program managementNGS-based diagnostic assay developmentRegulatory strategy for PMA submissions

Benefits

  • Competitive Benefits including medical, dental, vision, life and disability plans
  • Free testing for employees and their immediate families, fertility care benefits
  • Pregnancy and baby bonding leave, 401k benefits, commuter benefits
  • Employee referral program
Last updated Oct 22, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA
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