Clinical Development Director

4 weeks ago

London, Greater London, United Kingdom GSK Full time
Job Description

GSK is seeking a highly skilled Clinical Development Director to join our team in the Nephrology franchise. As a key member of our clinical development team, you will be responsible for providing clinical and scientific insights to support the development of new treatments for nephrology-related diseases.

Key Responsibilities
  • Design and lead clinical development protocols, studies, and programs in nephrology across all phases of development.
  • Develop and execute clinical development strategies, including study design and regulatory interactions.
  • Provide clinical expert input into regulatory documentation and lead regulatory interactions from a clinical perspective.
  • Work closely with research unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines.
  • Accountable for design and delivery of early clinical development plans and full development clinical development plans.
  • Lead the integrated evidence planning to address the needs of regulators, payors, and patients.
  • Participate/lead the clinical team and integrated evidence team.
  • Engage external academic and clinical experts to enhance quality and delivery of clinical programs/studies.
  • Provide clinical input into presentations, supporting documentation, and participation in governance bodies.
  • Escalate clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance.
  • Provide clinical input to regulatory documentation to support the desired indication.
  • Address clinical questions at meetings with regulatory authorities/ethics committees.
  • Accountable for regulatory reporting requirements, including Development Safety Update Reports (DSUR's) and IB updates.
  • Incorporate patient perspective in the design and conduct of clinical studies.
  • Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects.
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.
Why GSK?

GSK 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 want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

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