Talent.com
Sr Staff/ Principal Program Manager - IVD Development
Sr Staff/ Principal Program Manager - IVD DevelopmentDELFI Diagnostics, Inc. • Palo Alto, CA, US
Sr Staff / Principal Program Manager - IVD Development

Sr Staff / Principal Program Manager - IVD Development

DELFI Diagnostics, Inc. • Palo Alto, CA, US
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Job Description

Job Description

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

  • 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

  • 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.

    Crear una alerta de empleo para esta búsqueda

    Sr Staff Principal Program Manager IVD Development • Palo Alto, CA, US

    Ofertas similares
    Engineering Program Manager Sr Staff

    Engineering Program Manager Sr Staff

    Hewlett Packard Enterprise Company • San Jose, CA, United States
    A tiempo completo
    Engineering Program Manager Sr Staff.This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Hewlett Packard Enterprise is the g...Mostrar más
    Última actualización: hace 6 días • Oferta promocionada
    Sr. Director, Program Management

    Sr. Director, Program Management

    Synaptics Incorporated • San Jose, CA, United States
    A tiempo completo
    Synaptics is leading the charge in AI at the Edge, bringing AI closer to end users and transforming how we engage with intelligent connected devices, whether at home, at work, or on the move.As the...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Assistant Director IDD Programs

    Assistant Director IDD Programs

    Hope Services • San Jose, CA, US
    A tiempo completo
    Assistant Director Idd Programs.Hope Services is Silicon Valley's leading provider of services to people with developmental disabilities and mental health needs. We seek candidates who share our in...Mostrar más
    Última actualización: hace 21 días • Oferta promocionada
    Operation Program Manager (EPD II)

    Operation Program Manager (EPD II)

    Foxconn Industrial Internet - FII • San Jose, US
    A tiempo completo
    Quick Apply
    Operation Program Manager (EPD II) Foxconn Assembly LLC San Jose, CA What to Expect This position manages operational projects, ensuring alignment with ...Mostrar más
    Última actualización: hace menos de 1 hora • Nueva oferta
    Sr Director, Global Partner Program Office

    Sr Director, Global Partner Program Office

    Omnissa • Mountain View, CA, United States
    A tiempo completo
    Sr Director, Global Partner Program Office.Sr Director, Global Partner Program Office.Omnissa is the first AI-driven digital work platform, built to support flexible, secure, work‑from‑anywhere exp...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Director / Sr. Director, siRNA CMC

    Director / Sr. Director, siRNA CMC

    GondolaBio • Palo Alto, CA, United States
    A tiempo completo
    GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally ca...Mostrar más
    Última actualización: hace 6 días • Oferta promocionada
    Sr. Director, Program Management

    Sr. Director, Program Management

    Synaptics Inc. • San Jose, CA, US
    A tiempo completo
    Synaptics is leading the charge in AI at the Edge, bringing AI closer to end users and transforming how we engage with intelligent connected devices, whether at home, at work, or on the move.As the...Mostrar más
    Última actualización: hace más de 30 días
    Program Director - ERF

    Program Director - ERF

    LifeMoves • Santa Clara, CA, United States
    Indefinido +1
    LifeMoves is the largest and most effective provider of housing and services for neighbors experiencing homelessness in Silicon Valley since 1987. Our Mission is to end homelessness by providing int...Mostrar más
    Última actualización: hace 7 días • Oferta promocionada
    (Sr.) Learning and Development Manager

    (Sr.) Learning and Development Manager

    Delta Electronics Americas • Fremont, CA, United States
    A tiempo completo
    Delta, founded in 1971, is a global provider of power and thermal management solutions.Its mission statement, "To provide innovative, clean and energy-efficient solutions for a better tomorrow," fo...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Technical Program Manager / Scrum Master

    Technical Program Manager / Scrum Master

    Inherent Technologies • Pleasanton, CA, United States
    A tiempo completo
    Quick Apply
    MsoNoSpacing"> Must Have Technical / Functional S...Mostrar más
    Última actualización: hace 2 días
    Sr. Director, Corp FP&A

    Sr. Director, Corp FP&A

    Archer • San Jose, CA, United States
    A tiempo completo
    Archer is an aerospace company based in San Jose, California building an all-electric vertical takeoff and landing aircraft with a mission to advance the benefits of sustainable air mobility.We are...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Engineering Program Manager Sr Staff

    Engineering Program Manager Sr Staff

    Hewlett Packard Enterprise Development LP • San Jose, CA, United States
    A tiempo completo
    Engineering Program Manager Sr Staff.This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office. Hewlett Packard Enterprise is the g...Mostrar más
    Última actualización: hace 12 días • Oferta promocionada
    Staff Technical Program Manager, In-House Hardware Design and Development

    Staff Technical Program Manager, In-House Hardware Design and Development

    General Motors • Mountain View, CA, United States
    A tiempo completo
    Staff Technical Program Manager, In-House Hardware Design and Development.This role is categorized as Hybrid, and the successful candidate is expected to report to the Technical Innovation Center i...Mostrar más
    Última actualización: hace 29 días • Oferta promocionada
    Sr. Manager / Associate Director, Training

    Sr. Manager / Associate Director, Training

    BridgeBio • Palo Alto, CA, United States
    A tiempo completo
    When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement. In 2015, we pioneered a “moneyball for biotech” app...Mostrar más
    Última actualización: hace 12 días • Oferta promocionada
    Sr Program Manager

    Sr Program Manager

    Koch Industries • Fremont, CA, US
    A tiempo completo
    Sr Program Manager - Optical Solutions.At Koch, employees are empowered to do what they do best to make life better.Learn how our business philosophy helps employees unleash their potential while c...Mostrar más
    Última actualización: hace 21 días • Oferta promocionada
    Sr. GTM Program Manager-Tech & Marketing : 25-03586

    Sr. GTM Program Manager-Tech & Marketing : 25-03586

    Akraya Inc • Mountain View, California, United States
    A tiempo completo
    Quick Apply
    Primary Skills : Project Management (Expert), Marketing / Sales (Advanced), Cross-functional Leadership (Expert), Communication (Expert), Flexibility (Advanced). Location : MTV / SFO / SDG preferred.We are ...Mostrar más
    Última actualización: hace más de 30 días
    Sr. Director, Technical Program Management (AI / ML)

    Sr. Director, Technical Program Management (AI / ML)

    Capital One • San Jose, CA, United States
    A tiempo completo
    Director, Technical Program Management (AI / ML).Director, Technical Program Management (AI / ML).Are you interested in leading programs that deliver on critical business goals and build large scale pr...Mostrar más
    Última actualización: hace 23 días • Oferta promocionada
    Engineering Program Manager Sr Staff

    Engineering Program Manager Sr Staff

    Hewlett Packard Enterprise • San Jose, CA, United States
    A tiempo completo
    This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office. Hewlett Packard Enterprise is the global edge-to-cloud company advancing...Mostrar más
    Última actualización: hace 6 días • Oferta promocionada