CLIENTS AND PROJECTS

I HAVE DELIVERED A VARIETY OF CLIENT PROJECTS:

For a discovery-stage molecular diagnostics company, I developed a three-year strategic plan, reporting to the CEO:

  • Prioritize the competing commercial potential of several candidate products and present each product launch strategy
  • Develop the regulatory approach
  • Design alternative product-specific lifecycle maps with key decision points and data deliverables
  • Advise on design of analytic validation and clinical validation studies
  • Build relationships with key collaborators
  • Set up the hiring and infrastructure framework
  • Establish three-year publication and meeting presentation plan for each product
  • Present findings and recommendations to the Board

For a commercial-stage diagnostics company, I managed the clinical operations and provided strategic study guidance:

  • Oversee clinical operations function and staff and regulatory compliance
  • Develop critical study documents, including CRF
  • Perform risk assessment and implement procedures for reducing risk
  • Advise on strategic product positioning
  • Provide expertise on analytic validation, clinical validation and clinical utility design

For a development-stage diagnostics company, I served a management team function, reporting to the CEO:

Strategic:

  • Define product unmet clinical need, business case and clinical utility
  • Assess market and customer requirements
  • Build publication and data milestone plan in conjunction with key specialty medical society meetings
  • Develop clinical validation plans for multiple indications
  • Establish regulatory approach
  • Engage key opinion leaders

Clinical Operations

  • Source biosample cohorts
  • Develop prospective clinical protocols and all critical study documents
  • Oversee clinical operations function, including vendor selection and management
  • Provide all aspects of study management
    • Site startup, training and management
    • Regulatory compliance
    • Biosample integrity
    • Data verification and monitoring
    • Data management

Scroll through some of my selected presentations: