Sr Staff/ Principal Program Manager - Palo Alto - DELFI Diagnostics

Description

Sr Staff/ Principal Program Manager - IVD Development

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. 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

• 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

What You'll Bring to DELFI

• 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
• 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

$160,000 - $220,000 a year

The expected US base salary range for this position is $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.