Director Assay Development
Director Assay Development
Posted on :
17-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-03-2025
Job Description
About Us
DELFI Diagnostics Inc. (DELFI Diagnostics) is developing nextgeneration bloodbased tests that are reliable accessible and deliver a new way to help detect cancer. Employing advanced machinelearning methods to wholegenome sequencing data the DELFI (DNA EvaLuation of Fragments for early Interception) platform is built to address the highestburden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale including for historically underserved populations. DELFI Diagnostics platform relies on fragmentomics the discovery that cancer cells are more chaotic than normal cells and when they die leave behind telltale patterns and characteristics of cellfree DNA (cfDNA) fragments. FirstLook Lung for individuals eligible for lung cancer screening is DELFI Diagnostics first laboratorydeveloped screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through lowdose CT including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes we serve humanity when we:
Lead with Science Anchor in Pragmatism: We pioneer lifechanging science by ensuring quality transparency and rigor at all times. We explore thoughtfully experiment smartly and deliver impact with conviction.
Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product we aim to disrupt the path of cancer for all no matter geography or socioeconomic class
Put We over I: We are a home for highperforming people. Through teamwork we build collective intelligence. Each of us wins when those we serve and those who serve with uswin. We show up with empathy humility and integrity at every step of the journey.
DELFI has 12 designated inoffice working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices
As the Director of Assay Development you will build and develop collaborative teams across our organization while driving forward our innovative lung cancer screening product. In this role youll leverage your technical expertise to guide multidisciplinary teams through the development lifecycle fostering an environment where creative problemsolving and rigorous science thrive together. Your ability to communicate complex concepts inspire your team members and build bridges between departments will be just as valuable as your scientific knowledge.
What youll do
- Lead the strategic design and development of LDT and IVD diagnostic tests for our cancer screening platform
- Build and manage highperformance technical teams to successfully develop and launch products under formal IVD design controls
- Drive the development of automated processes that are scalable for production environments
- Oversee crossfunctional collaboration between R&D clinical regulatory and manufacturing teams
- Ensure compliance with regulatory requirements including CAP/CLIA and FDA IVD standards
- Contribute to innovation through development of novel assay technologies and approaches
- Present complex technical concepts to diverse stakeholders and influence strategic decisions
- Optimize assay performance through critical parameter management and statistical process control
What youll bring to DELFI
- PhD in Molecular Biology Biochemistry Chemistry or a similar discipline
- 8 years of professional assay development experience with specific experience designing and developing LDT and IVD diagnostic tests
- Proficiency in a broad range of laboratory techniques for molecular diagnostics including immunoassays protein biochemistry molecular biology proteomics genomics and other omics
- 6 years of experience managing technical teams to product launch in a crossfunctional environment under formal design controls
- Experience developing automated processes scalable for production environments (IVD preferred)
- Strategic and tactical leadership capabilities in building highperformance resultsdriven teams
- Experience working in regulated environments (CAP/CLIA and IVD)
- Excellent written and verbal communication skills with ability to clearly convey complex concepts
- Evidence of innovation and personal accomplishment through patents publications and launched LDT/IVD products
- Ability to work onsite at our Palo Alto laboratory five days a week and travel to the Baltimore office periodically
- Background in next generation sequencing technologies blood tests and cancer biology
- Familiarity with databases bioinformatic analysis and general principles of machine learning algorithms
- Experience with formal product development methodologies such as DOE Six Sigma statistical process control lean.
- Success building product development processes and launching products in a fastpaced startup environment
Preferred
$210000 $240000 a year
Total Compensation at DELFI is a combination of salary bonus equity and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skillset years & depth of experience certifications & relevant education geography.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status.
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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