
Delfi Diagnostics detects cancer early, when it is most curable, using high-precision non-invasive blood tests. It uses artificial intelligence and genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients. The company was founded in 2019 and is based in Baltimore, Maryland.

Delfi Diagnostics detects cancer early, when it is most curable, using high-precision non-invasive blood tests. It uses artificial intelligence and genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients. The company was founded in 2019 and is based in Baltimore, Maryland.
Mission: Early cancer detection via fragmentomics-based, ML analysis of cell-free DNA from blood
Founded: 2019
Lead product / tech: DELFI-TF (genome-wide cfDNA fragmentation analysis with machine learning)
Notable financing: $225M Series B (July 18, 2022); total funding reported ~$330.5M
Headcount (approx.): 176 employees
Early cancer detection and treatment monitoring using liquid biopsy (fragmentomics of cell-free DNA).
2019
Biotechnology Research
$225,000,000
Announced Series B to develop portfolio of liquid biopsy tests
“Participation from strategic and institutional investors including Eli Lilly, Point72, Brown Advisory, Menlo Ventures, OrbiMed, Samsara BioCapital, T. Rowe Price, and others”
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About Us
Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.
Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole-genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
Lead with Science, Anchor in Pragmatism : We pioneer life-changing science by ensuring quality, transparency, and rigor at all times.
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 high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us win. We show up with empathy, humility, and integrity at every step of the journey.
About The Role
The Program Director will lead cross-functional teams in the development and validation of in vitro diagnostic (IVD) products, ensuring seamless coordination across R&D, regulatory, quality, clinical, and product management. This role requires strategic oversight of multiple complex projects from concept through regulatory submission and launch, with a strong emphasis on analytical and clinical validation activities.This position is open to candidates at Sr Staff or Principal level, with responsibilities and scope scaled appropriately based on experience.
What You'll Do
IVD Project Management
Analytical and Clinical Validation Project Management
PMO Process Management
Strategic Planning and Communication
What You'll Bring to DELFI
Education
Bachelor's degree in Life Sciences, Engineering, or related technical field; advanced degree (MS, PhD, or MBA) strongly preferred
Relevant industry experience may compensate for advanced degree requirements. Candidates with Bachelor's degree and 8+ years of directly relevant IVD/medical device program management experience will be considered
Experience
6-10+ years of experience in IVD or medical device product development, with 3-7+ years in demonstrated cross-functional leadership roles
Experience managing analytical and clinical validation studies for 2-4+ IVD products across varying complexity levels
Proven track record of successful regulatory submissions (510(k), PMA, or IVDR) and product launches, with more senior candidates having led complex submissions (PMA or Class III devices)
Experience with program management tools like Smartsheet, MS Project, Google Office Suite, Jira
History of managing complex, multi-year programs with multi-million dollar budgets
Technical Knowledge
Solid to deep expert-level understanding of IVD development lifecycle and regulatory pathways, with breadth increasing with seniority
Working to advanced knowledge of analytical and clinical validation requirements and statistical methods, with senior candidates able to guide statistical strategy and interpret complex data
Familiarity to expert proficiency with relevant regulations: FDA 21 CFR Part 820, QSR, IVDR, ISO 13485, CLIA, with senior candidates demonstrating ability to navigate regulatory uncertainty
Understanding to strong expertise in design controls, risk management (ISO 14971), GCP, CLSI, and quality systems, with senior candidates driving interpretation and application across programs
Deep understanding of IVD development lifecycle and regulatory pathways
Skills and Competencies
Exceptional leadership and influencing skills without direct authority
Outstanding communication skills with ability to translate complex technical concepts for diverse audiences
Strong business acumen and strategic thinking capabilities
Expert project management skills with proficiency in MS Project, Smartsheet, Jira, or similar tools
Analytical mindset with strong problem-solving abilities to find creative solutions and collaborate with teams to manage risks and meet strategic goals
Ability to thrive in fast-paced, dynamic environments with shifting priorities
PMP, PgMP, or equivalent certification preferred
Success In This Role
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.