**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

• Cross-Functional Leadership
• Lead and coordinate cross-functional project teams including R&D scientists, regulatory affairs, quality assurance, clinical operations, and engineering stakeholders
• Serve as the primary point of contact and decision-maker for program execution, ensuring alignment across departments
• Build consensus among diverse stakeholders with competing priorities while maintaining project momentum
• Foster a collaborative team environment that drives innovation, accountability, and results
• Escalate critical issues to executive leadership with proposed solutions and risk mitigation strategies

IVD Project Management

• Drive the end-to-end integration of IVD product development, accountable from feasibility through regulatory clearance/approval and market launch
• Develop and maintain comprehensive project plans, timelines, budgets, and resource allocation across multiple concurrent programs
• Identify and manage program risks, dependencies, and critical path activities
• Ensure projects comply with applicable regulatory requirements (FDA 21 CFR Part 820, IVDR, CLIA) and quality standards (ISO 13485)
• Monitor project performance against key milestones, budget targets, and quality metrics

Analytical and Clinical Validation Project Management

• Collaborate with key technical stakeholders to drive the execution of analytical validation studies including accuracy, precision, analytical sensitivity/specificity, reportable range, and stability
• Partner with clinical team to oversee and manage the timelines and dependencies and budget for clinical validation planning, protocol development, site selection, and enrollment strategies
• Drive cross-functional review of validation data to ensure regulatory readiness and technical robustness
• Ensure validation activities meet FDA, CLIA, and international regulatory requirements
• Drive generation and completion of validation protocols, statistical analysis plans, and study reports

PMO Process Management

• Implement and maintain PMO best practices, standard operating procedures, and governance frameworks
• Establish and track program KPIs, metrics, and dashboards for executive visibility
• Lead project portfolio reviews, resource planning sessions, and prioritization exercises
• Drive continuous improvement initiatives to enhance project delivery efficiency and quality
• Develop and maintain project templates, tools, and documentation standards
• Facilitate stage-gate reviews and ensure appropriate documentation for decision-making

Strategic Planning and Communication

• Translate business strategy into executable program roadmaps
• Present program status, risks, and recommendations to core team, subteams and senior leadership
• Prepare and deliver technical and strategic presentations to internal and external stakeholders
• Develop business cases and investment proposals for new program initiatives

What You'll Bring to DELFI

Success In This Role

• On-time delivery of program milestones and regulatory submissions
• Budget performance and resource utilization efficiency
• Quality of validation data and first-time approval rates
• Team engagement and stakeholder satisfaction scores
• Portfolio throughput and cycle time improvements

An equal opportunity employer

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.

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.********