Natera
Senior Director, Development - ECD and MCED Products
San Carlos, CA · Director
Sponsorship not specified$268k-$335kDetected 6 days ago
StatisticsFDA RegulatoryBioinformaticsMolecular BiologyNGSMedical DevicesResearchExperimental DesignLeadershipCommunicationCollaborationBiostatistics
Stay score
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.
Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- 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
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
- Take accountability for the phase-gated execution of all ECD and MCED programs, overseeing the development, design verification, and validation of NGS-based cancer detection IVD devices using cfDNA, methylation and other analyte classes.
- Build, retain, and mentor a leadership team of directors, managers, and scientists, optimizing the organization's budget and external vendor partnerships
- Think team by partnering directly across research, bioinformatics, biostatistics, software, clinical, regulatory, and commercial functions to deliver design-controlled IVD products in a highly cross-functional environment
- Communicate portfolio status, risks, and tradeoffs to executive leadership and drive alignment on enterprise priorities
- Ensure the organization operates within Natera's QMS and all applicable guidance (ISO 13485:2016, FDA QMSR (21 CFR Part 820), ISO 14971, IEC 62304, etc), and partner with Quality to maintain audit readiness and strengthen design control practices
- You will establish priorities, allocate resources, and represent development with the FDA and executive leadership, ensuring that scientific rigor and data drive all regulatory and portfolio decisions.
- 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
- 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
- Demonstrated experience managing multiple concurrent development programs, with full accountability for budget, resource allocation, and prioritization
- Experience in liquid biopsy or molecular diagnostics for clinical oncology, specifically cfDNA-based detection of low-abundance signals at high specificity
Nice to have
- Served as the principal technical leader on a PMA submission for an NGS-based oncology device or an equivalent IVD approval outside the US (e.g., IVDR Class C/D, PMDA, NMPA)
- Experience with large prospective or pivotal screening studies in partnership with clinical and biostatistics leaders
- Experience with multi-cancer or cancer screening assays, including multi-cancer classification, cancer signal origin prediction, and operating points requiring very high specificity
- Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
- 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!
Skills
- Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR
- Ability to translate scientific strategy into rigorous business cases and resourcing plans, exercising judgment under uncertainty
- Join Natera as the Senior Director of Development for our Early Cancer Detection (ECD) and Multi-Cancer Early Detection (MCED) portfolio.
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.