Christopher Vandepas

• FDA Approval Leadership: Managed portfolio prioritization, risks, and investment to achieve the FDA approval for Guaredant Shield while balancing the R&D budget and long range plan impacts with shifting approval and launch targets. Directed cross-functional teams to achieve the first FDA approval for a liquid biopsy NGS assay (Guardant360 CDx), revolutionizing cancer diagnostics and expanding patient access to precision medicine.
  Partnered with clinical, regulatory, and R&D teams to establish phase-gate processes, ensuring timely submission and approval milestones.
  
• Biopharma Portfolio Creation: Designed and launched the biopharma development services portfolio within the oncology portfolio, generating significant revenue streams and bolstering Guardant Health’s partnerships with leading biopharma companies.
  Oversaw project pipelines from preclinical to clinical stages, ensuring alignment with strategic goals and timelines. This business has grown into a significant revenue stream of over $200M with sample growth of 15-20% YoY.
  
• Portfolio Scale and Planning: Worked with cross-functional and executive leadership to develop Longe Range Plans inclusive of investment needs for R&D, S&M, and G&A to reach revenue targets and scale. The framework, business cases, and intake processes are now standardized.
  
• Governance and Operational Excellence: Established governance frameworks for the oncology, screening, MRD, and biopharma portfolios, enabling transparency and data-driven decision-making.
  Improved resource allocation efficiency by 20% through the implementation of capacity management tools and predictive forecasting.
  
• Stakeholder Engagement and Reporting: Led regular portfolio reviews with senior leadership and external stakeholders, directly influencing strategic decisions and funding allocations.
  Delivered on operational goals that contributed to Guardant Health’s recognition in the TIME100 Most Influential Companies list and TIME’s Best Inventions of 2024.
  
• Skills: Portfolio, Program and Project management · Strategic Planning · Cross-functional Collaborations · Leadership and team management · Product development and launch · Product Development in the CLIA, CAP, NYS, RUO, IUO, and IVD spaces · Risk Management · Continuous Improvement · Regulatory Compliance · Market analysis and customer needs assessment.

• Strategic Analysis and Governance:Conducted strategic analysis for project approval committees and governance bodies, ensuring alignment of projects with organizational priorities and resource availability.
  Collaborated with leadership to evaluate project proposals, providing actionable insights to guide decision-making.
  
• Operational Strategy Design and Execution:Designed operational and execution-based strategies that aligned with overarching business objectives and ensured seamless implementation of strategic and operational goals.
  Developed execution roadmaps for major initiatives, driving efficiency and measurable outcomes.
  
• Leadership and Team Direction:Provided leadership and direction to the Portfolio and Program Management organization, fostering a high-performing team culture.
  Functionally managed a team of Portfolio and Project Managers, overseeing initiatives across company divisions and strategic priorities.
  
• Performance Management:Established and tracked Portfolio and Project performance metrics aligned with organizational goals and objectives, ensuring projects met quality, time, and budget targets.
  Delivered quarterly performance reviews to senior leadership, highlighting progress and areas for improvement.
  
• Workforce Planning and Talent Development:Led workforce planning initiatives to identify future talent needs and build a robust pipeline to support sustained growth and operational efficiency.
  Mentored emerging leaders within the portfolio and project management teams, enhancing skills and career development.
  
• Cross-Functional Collaboration:Worked closely with cross-functional teams, including R&D, Clinical, Regulatory, and Operations, to ensure reliable delivery of program and project support and execution.
  Facilitated communication and coordination between teams to address interdependencies and resolve bottlenecks.
  
• Budget Planning and Management:Planned and managed departmental budgets, ensuring alignment with long-term strategic objectives.
  Monitored actual performance against targets, implementing corrective actions as necessary to maintain fiscal discipline.
  

• Lead a cross functional product development core team in the execution of deliverables. Work closely with R&D, Operations, Quality, Marketing, Regulatory, Medical Affairs and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans
• Lead a cross functional joint project team with external partners to align and execute the project per contractual milestones
• Communicate program updates to the core team, to functional management and to executive leadership both internally and externally
• Ensure timely team completion of documents required for the product design history file
• Lead team efforts to mitigate risks and resolve issues quickly as they arise
• Lead the team through problem resolution including root cause analysis and corrective action
• Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership
• Lead the program planning process
• Ensure effective communications with the Core Teams using a variety of tools and channels
• Define program resource needs, negotiate program resourcing plans and track resource usage over the course of the program
• Perform other related duties and assignments as required

• Lead cross functional core teams in the development of IVD assays.
• Ensure delivery of the product through launch.
• Maintain schedule and scope.
• Maintain compliance with the quality system and regulatory requirements.
• Developed and initiated projects, managed costs, and monitored performance.
• Tracked hours and expenses to keep project on task and within budgetary parameters.

• Commanded projects from initiation to launch through Group Operating Procedures and Change Control Processes.
• Developed project charters and contracts for complex cross-functional development projects.
• Designed and implemented proof-of-concept, innovation, and product development processes.
• Created project management plans inclusive of risk, cost, resource, and communication plans with expert judgement, three-point estimating, PERT, and negotiate lead and lag times with functional managers and core team members.
• Led collaboration efforts, scrums, communication logs, decision making logs, and agile meetings from small core teams to large scale projects involving multiple companies in different countries.
• Managed the accountability for large-scale manufacturing setup projects including procurement, process development, qualification and validation activities (SAT/FAT/IQ/OQ/PQ/PV).
• Developed and co-develop business plans and cases to present to senior management and scientific committees to gain project approval.
• Planned, monitored and controlled the project management development processes for IVD products regulated under ISO 13485:2016 design control standards that meet CDC, WHO, and FDA guidance.
• Led planning, integration, and branding teams through a successful acquisition.
• Created, presented, and gained approval for dedicated phase gates and design control reviews while continuing to update key performance metrics i.e. cost, milestone deliverables, and maintaining document approval matrices.
• Estimated and wrote capital expenditures for setting up new manufacturing lines including building and validating ISO certified clean rooms.
• Managed day-to-day core team meetings utilizing physical project boards, shared action item tools, virtual tools including Basecamp, Go-To Meeting, Webex, and Google Hangouts tracking projects in agile environments.
• Identified, vetted, and collected proposals from design houses, original equipment manufacturers, and material sub-suppliers as part of production line setup.
• Led front-end supply chain activities including forecasting, creating bill-of-materials, and calculating defect rates based on qualitative and quantitative risk analysis and design of experiments.
• Developed standard operating procedures for product development cycles that meet state-of-the-art regulatory requirements and industry best practices.

Product Manager Accomplishments

• Developed product business plans, charters, and contracts for complex cross-functional development projects.
• Successfully adopted business cases to present to senior management and scientific committees to gain project approval.
• Performed a market validation study for a new molecular diagnostics instrument including bottom-up analysis through customer visits, market segments, and extrapolating financial models for US and OUS markets.
• Coordinated project launches with website and promotional materials in alignment with Commercial teams.
• Performed full end-to-end development efforts, schedule and cost models for potential products.
• Managed beta site testing at customer sites with Field Application Scientists, Commercial and Key Accounts, and customer representatives.
• Developed competitor analysis for molecular instruments and consumables.
• Assisted in industry trade show setup and customer meetup.
• Business Development Accomplishments
  Emphasized a culture of leadership, collaboration, and innovation that creates positive and efficient core team engagement.
  Maintained supplier, vendor, and customer relationships
• Effectively negotiated and influence senior management teams to direct resources for projects and project needs.
• Led a product development team for analyte specific and general purpose reagents that saw a three-fold increase in launch productivity year-over-year.
  

• Developed and initiated projects, managed costs, and monitored performance.
• Fostered relationships with vendors to promote positive working relationships.
• Managed projects from procurement to commission.
• Reined in project costs while meeting key milestones.
• Reduced expenditures by effectively negotiating vendor and service contracts to drive savings.
• Provided management for internal personnel, contractors and vendors.
• Achieved project deadlines by coordinating with contractors to manage performance.
• Oversaw high profile projects for by planning, designing, and scheduling phases.
• Drove team success through shared vision and recognition of quality performance.
• Modified and directed project plans to meet organizational needs.