Sr Staff/ Principal Program Manager - IVD Development
hace 2 días
Palo Alto
Job DescriptionAbout 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 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 strategiesIVD 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 metricsAnalytical 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 reportsPMO 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-makingStrategic 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 initiativesWhat 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 preferredSuccess 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 improvementsThe expected US base salary range for this position $160K - $220k plus 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.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.
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