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Clinical Development Director

1 month ago

Collegeville, Indiana, United States GlaxoSmithKline Full time

Accelerate Business Performance across and drive global operational support as a Clinical Development Director at GlaxoSmithKline.

The Clinical Sciences Lead is the single point of accountability for the development of the scientific design, medical governance, and interpretation of results of a study. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan.

Key Responsibilities:

  • Appropriate incorporation of design of study into protocol O PRF reviewed and approved clinical study proposal (CSP)
  • Presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct
  • Scientific Oversight for the Study
  • Benefit risk of the study
  • Ensuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results
  • Clinical monitoring and ongoing review of clinical data and study conduct to assure patient safety and scientific integrity
  • Medical governance for the study
  • Medical governance of study, including medical monitoring

Requirements:

  • Solid understanding of clinical research and biostatistics principles
  • Ability to research and use data from a range of sources to make robust fact-based decisions
  • Demonstrated leadership success and record of high performance and delivery
  • Ability to work collaboratively with multiple stakeholders

About GlaxoSmithKline:

GlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).