Natera
Director, ECD Development
San Carlos, CA · Director
Sponsorship not specified$229k-$286kDetected 6 days ago
StatisticsFDA RegulatoryBioinformaticsMolecular BiologyNGSMedical DevicesResearchLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 24 green-card filings in this occupation, 96% were for a worker who already held the job.
Green-card follow-through: 88%
Of 17 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.96% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
15 transfer filings in the last year, covering 15 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products.
- Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams
- Serve as the technical subject matter expert in correspondence and meetings with the FDA, defending performance evidence using data
Responsibilities
- Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes
- Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams
- Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates
- Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA
- Build, develop, and retain a high-performing organization of scientists and managers, optimizing program budgets and external vendor partnerships
- Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
- You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support.
- Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions.
- Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
Requirements
- Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field
- 6+ years of experience in IVD or diagnostic device development under design controls
- 5+ years of experience directing scientific or technical teams
- Experience in liquid biopsy or molecular diagnostics for clinical oncology, specifically cfDNA-based detection of low-abundance signals at high specificity
- Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations
Nice to have
- Experience with pivotal clinical validation studies for cancer screening or early detection, in partnership with biostatistics
- Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
- Experience with bioinformatics pipelines and companion software as components of a regulated IVD (IEC 62304)
- BBB announcement on job scams
- FBI Cyber Crime resource page
- When you join Natera, you'll work hard and grow quickly.
- We also offer a generous employee referral program!
- For more information, visit www.natera.com.
Skills
- Demonstrated direct experience in FDA interactions (e.g., Pre-Submission meetings) for a molecular diagnostic or NGS-based device
- Working knowledge of FDA premarket pathways for high-complexity IVD approvals
- Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR
Compensation
- The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
Benefits
- Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.
- Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
- Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
Company info
- Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
- We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.
Equal opportunity
- Equal Opportunity Employer.
This listing is sourced directly from Natera's careers page and normalized into a canonical job model.