Sr Staff/ Principal Program Manager - Palo Alto, CA

Only for registered members Palo Alto, CA, United States

1 month ago

Job summary

About Delfi Diagnostics: Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.

Responsibilities

Cross-Functional Leadership Lead and coordinate cross-functional project teams including R&D scientists regulatory affairs quality assurance clinical operations 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 results Escalate critical issues to executive leadership with proposed solutions risk mitigation strategies IVD Project Management Drive the end-to-end integration of IVD product development accountable from feasibility through regulatory clearance/approval market launch Develop maintain comprehensive project plans timelines budgets resource allocation multiple concurrent programs Identify manage program risks dependencies critical path activities Ensure projects comply applicable regulatory requirements FDA 21 CFR Part 820 IVDR CLIA quality standards ISO 13485 Monitor project performance key milestones budget targets quality metrics Analytical Clinical Validation Project Management Collaborate technical stakeholders drive execution analytical validation studies accuracy precision analytical sensitivity/specificity reportable range stability Partner clinical team oversee manage timelines dependencies budget for clinical validation planning protocol development site selection enrollment strategies Drive cross-functional review validation data ensure regulatory readiness technical robustness Ensure validation activities meet FDA CLIA international regulatory requirements Drive generation completion validation protocols statistical analysis plans study reports PMO Process Management Implement maintain PMO best practices standard operating procedures governance frameworks Establish track program KPIs metrics dashboards executive visibility Lead project portfolio reviews resource planning sessions prioritization exercises Drive continuous improvement initiatives enhance project delivery efficiency quality Develop maintain project templates tools documentation standards Facilitate stage-gate reviews ensure appropriate documentation decision-making Strategic Planning Communication Translate business strategy executable program roadmaps Present program status risks recommendations core team subteams senior leadership Prepare deliver technical strategic presentations internal external stakeholders Develop business cases investment proposals new program initiatives

Job description

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