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ViiV Medical Affairs Director - Early Development

GSK
Full-time
Remote friendly (Durham, NC)
United States
Medical Affairs

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Role Summary

Role: ViiV Medical Affairs Director - Early Development. Location: UK – London – New Oxford Street, Durham 300 Morris Street. This role leads medical strategy for a portfolio of Early Development assets, providing strategic medical insights into R&D and commercialization, profiling patient pathways and mapping the evolving treatment landscape. You will align asset profiles and evidence generation plans with clinical development and regional partner functions, and create compliant medical education and scientific materials for internal and external use. You will collaborate with R&D, Global Medical Sciences, Commercial and Marketed Product Teams, Regulatory, Finance, healthcare professionals, advocacy groups and others to deliver project-critical milestones and ensure a smooth transition to an asset-specific GML when appointed.

Responsibilities

  • Provide opinion based on broad knowledge and close study of HIV and emerging external environment, with clear focus on patients and unmet medical needs.
  • Deploy strong analytical thinking to quickly assess large amounts of information and distil into key messages and actions.
  • Ensure that prescriber and provider insight generation and gaps analysis inform target product profiles (TPP) and the scope and content of development plans for all programs in Early Development.
  • To support Early Development Commercial Lead, the Early Development Market Access Lead and the Early Development Health Outcomes Lead as part of the Pipeline Cross Functional Team.
  • To inform Early Development discussions and decisions from Global Medical Perspective.
  • Take accountability for the asset's medical governance and for approval of materials and activities to ensure they are compliant with GSK Code of Practice, standard operating procedures, and with external Industry standards Including the ABPI Code of Practice.
  • To mitigate risk, ensure that data communication is fair and balanced and comply with emerging regulatory and legal requirements.
  • Ensure compliance with all applicable corporate policies and SOPs.

Qualifications

  • Medical Doctor with specialisation, PhD or extensive industry expertise in one or more areas of focus (immune and inflammatory diseases, infectious diseases, preferably HIV.
  • Proven track record for high performance delivery in Medical Affairs or R&D
  • A Medical Affairs approach to understanding and strategizing a disease area through critical insights into the needs, behaviours and priorities of patients, practitioners and healthcare systems.
  • Ability to manage ambiguity, evaluate benefit and risk and take appropriate accountability for decision making.
  • Examples of curiosity and agility; able to pivot to new areas of focus, assimilate information rapidly and identify critical questions that will drive decision-making and planning.
  • Experience in the effective exchange of scientific information, maintenance of high professional standards and adherence to internal and external codes of practice.
  • Proven track record in influencing peers and managing team members in a matrix organization. Strong teamworking and relationship building skills. Strong influencing skills across and within organizations.