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DELFI Diagnostics · 2 weeks ago

Sr Staff/ Principal Program Manager - IVD Development

Palo Alto, CA

Full-time

Hybrid

Senior Level, Lead/Staff

6+ years exp

DELFI Diagnostics, Inc. is a Johns Hopkins spinoff focused on non-invasive cancer detection through advanced technologies. The Program Director will lead cross-functional teams in the development and validation of in vitro diagnostic products, ensuring seamless coordination across various departments and driving projects from concept to regulatory submission and market launch.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical

Responsibilities

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

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

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

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

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

Qualification

IVD product developmentRegulatory submissionsAnalytical validationClinical validationProject management toolsStatistical methodsRisk managementCross-functional leadershipBusiness acumenPMP certificationLeadership skillsCommunication skillsStrategic thinkingProblem-solving abilities

Required

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

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

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

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