Sr Staff Principal Program Manager IVD Development

Palo Alto, CA - USA

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

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 productwe 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 position is open to candidates at Sr Staff or Principal level with responsibilities and scope scaled appropriately based on experience.

What Youll 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 Youll Bring to DELFI

Education
Bachelors 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 Bachelors 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

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

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.

Required Experience:

Manager

About UsOur 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 who...