Clinical Development Director - Renal

GSK-posted 3 months ago
Collegeville, PA
5,001-10,000 employees
Chemical Manufacturing
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The Clinical Development Director- Renal provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including renal translational and clinical development strategies and clinical studies. You will work cross-functionally to develop and execute clinical development plan(s) up to, and including, Proof of mechanism/Proof of concept studies.

  • Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP.
  • Generate the data and evidence required to determine a target or medicines' potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
  • Define and deliver the clinical pillars of the translational table.
  • Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
  • Seek and maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
  • Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.
  • Provides effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
  • Contributes to the study team discussions on indication planning, incorporates input from across disciplines to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
  • Designs clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input.
  • Develops clinical study protocols, amendments, investigator brochures, clinical study reports etc.
  • Inputs to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
  • Provides medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study.
  • Accountable for leading the CMT on an EPU program.
  • Collaborate with cross-functional teams to ensure cohesive and comprehensive translational and clinical development plans.
  • Actively leads the end-to-end clinical development strategy for an EPU program.
  • Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board.
  • Clinical evaluation of business development opportunities.
  • Stays abreast of advancements in renal research, clinical trial methodologies, competitive environment and regulatory space.
  • Gathers and supports the integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile.
  • Demonstrates ability to influence others at project, departmental and inter-departmental levels.
  • PhD or Pharm D (or equivalent) with 1-3 years postgrad experience in a relevant postgraduate training or job.
  • Minimum of 3 years of experience in clinical research and development.
  • Robust knowledge of renal specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
  • Experience working with global regulatory agencies and managing global clinical trials in nephrology.
  • Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
  • Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment.
  • Medical Degree and Board certified/eligible in Nephrology.
  • Experience in contributing to NDA, BLA, or MAA submissions preferred.
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