Sr Staff/ Principal Program Manager - IVD Development

DELFI Diagnostics, Inc.•Palo Alto, CA

About The Position

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.

Requirements

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
Deep understanding of IVD development lifecycle and regulatory pathways
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

Nice To Haves

PMP, PgMP, or equivalent certification preferred

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