Clinical Development Director

1 month ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Clinical Development Director - Nephrology to join our team at GlaxoSmithKline. As a key member of our clinical development team, you will be responsible for providing clinical and scientific insights to the Nephrology franchise, including emerging indications and adjacencies.

Key Responsibilities
  • Design and lead clinical development protocols/studies/programs in Nephrology across all phases of development.
  • Accountability for clinical development strategy, including study Ph1-2/3 design.
  • Provide clinical expert input into regulatory documentation and lead regulatory interactions from a clinical perspective.
  • Work closely with research members to define prioritized clinical indications for early targets and integrate inputs from across disciplines.
  • Accountability for design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile.
  • Accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators.
  • Accountability for leading the integrated evidence planning to address the needs of regulators, payors, and patients.
  • Engage external academic and clinical experts to enhance quality and delivery of clinical programs/studies.
  • Escalate clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate.
Requirements
  • Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification.
  • Significant proven clinical or scientific expertise in nephrology.
  • Industry or academic experience in translational medicine and early/late phase drug development.
  • Understanding and knowledge of early/late drug development and translational sciences.
About Us

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).

We believe in an agile working culture for all our roles. We are an equal opportunities employer and welcome applications from all qualified candidates.

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