Supports business decision-making and progression in medical product innovation and development

Descriptors

  • Works as part of a team in creating the Target Product Profile and designing the Clinical Development Plan by providing medical and clinical input within the context of the business development plan and commercial feasibility.
  • Provides a medical contribution to due diligence with respect to product profiling, positioning within the market and addressing unmet medical needs.
  • Identifies the possible position in the portfolio for products in development or during in-licensing.
  • Involved in medical product lifecycle planning and management.
  • Demonstrates an ability to facilitate business decision-making during the development and lifecycle of the medical product.

Evidence to inform to decision

  • Summary of Product Characteristics (SmPC)
  • Target Product Profile document
  • Clinical Development Plan
  • Decision to progress to next clinical development phase
  • Health Economics/Outcomes Research data in clinical development to support HTA and other post authorisation activities
  • Reports and presentations
  • Regulatory reclassification documents
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 1 – Professional values and behaviours

Domain 2 – Professional skills:

  • Communication and interpersonal skills

Domain 5 – Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 7 – Capabilities in safeguarding vulnerable groups

Domain 9 – Capabilities in research and scholarship