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Clinical Development Director
2 months ago
GSK is seeking a highly experienced Clinical Development Director - Nephrology to join our team. As a key member of our Clinical Research and Early Programs Immunology 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, as required by business imperatives.
- Accountability for clinical development strategy, including study Ph1-2/3 design, providing clinical expert input into regulatory documentation, and leading 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 (scientific, clinical, commercial, regulatory, and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan, and integrated evidence plan.
- Accountability for design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development.
- 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.
- 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, with experience of setting and executing scientific strategy, while being mindful of overall goals.
- Understanding and knowledge of early/late drug development and translational sciences.
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 believe in an agile working culture for all our roles. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.