Clinical Development Director

1 day ago

Stevenage, Hertfordshire, United Kingdom GSK Full time
Job Opportunity

The Global Clinical Sciences Lead will be accountable for the development of the scientific design, medical governance, and interpretation of study results.

Key Accountabilities

  • Single point of accountability for study design, including integrated input from internal/external experts.
  • Study objectives must be consistent with decision criteria in the CDP, ensuring Go/No-Go criteria has been set.
  • Appropriate incorporation of design of study into protocol. The PRF must review and approve the clinical study proposal (CSP).
  • Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct.

Scientific Oversight for the Study

  • Benefit risk of the study.
  • Ensure study analysis plan is aligned to objectives of the protocol and be 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. This includes ongoing review of protocol deviations and implementation of remedial plans.
  • Medical governance for the study.

Evidence Generation & Outputs for the Study

  • Interpret study data to create the scientific content of the Clinical Study Report (CSR).
  • Prepare study results for abstracts, posters, and presentations for scientific meetings, congresses, external journal publications.
  • Prepare clinical content of regulatory documents and interact with global regulatory authorities for the study.

Study Level Collaboration

  • Partner with the Study Delivery Lead to ensure optimal delivery of the study.
  • Maintain close collaboration with various functions, including drug safety, regulatory affairs, medical affairs, and clinical trial operations at the study level.

Why GSK?

  • GSK focuses on values and expectations and a culture of innovation, performance, and trust. We look for the following capabilities: agile and distributed decision-making, managing individual and team performance, and delivering high-quality results.

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