VP, Clinical Research Head, Nephrology Therapeutic Area

Role Summary

GSK seeks a VP Clinical Research Head (CRH), Nephrology within the Advanced Portfolio Unit. The Advanced Portfolio Unit works within the Respiratory, Immunology and Inflammation Research Unit (RIIRU). This senior role leads across the full discovery and development lifecycle of the nephrology portfolio, requiring close partnering with RIIRU leaders and cross-functional partners. You will operate across the broader matrix at a leadership level, partnering with line heads in biology, asset/medicine leadership, commercial, precision medicine, biostatistics, regulatory and medical affairs, and contribute to project and above-project governance.

The role includes evolving disease area strategies within nephrology and potential adjacencies, ensuring the quality and robustness of the medicine vision, integrated evidence plan and innovative trials for programs to support the development, approval, commercialization, and patient access to differentiated medicines with proven value. You will also be accountable for Medical Governance for clinical programs. On-site presence required (minimum two days per week) at one of GSK’s US sites (Upper Providence, PA or Waltham, MA) or UK sites (London - New Oxford Street or Stevenage).

• Lead building a portfolio of programs within the Nephrology TA that have clear potential for product differentiation, tractability in development and with associated technical success probabilities that can support clear investment decisions.
• Be accountable for the delivery of the full spectrum of advanced clinical development studies and submissions, Ph1b/2a through filing in nephrology.
• Be the single point of accountability for disease area strategy developed with input from internal GSK leaders & external academic thought leaders, research leads, regulatory authorities, investigators, and patient groups.
• Lead milestone transitions from candidate selection to filing/launch, guiding Clinical Leads on optimized strategies for programs and alternative pathways to enable informed, smart risk-taking.
• Provide Medical Governance with specific accountability for managing and mentoring clinical staff in the disease area line and ensure proper training and compliance with internal and external policies, guidance, laws, and codes.
• Develop and maintain excellence in translational and clinical leadership in the disease area.
• Ensure the quality of clinical deliverables within the disease area including all documents and submissions including clinical data, through methods such as peer review, knowledge sharing/management, and standards and compliance.
• Function as Data Steward of the clinical data for the disease area (may include multiple assets), with oversight of breadth of disease data strategies and related data science efforts relevant to Nephrology TAs, to ensure activities are applied to benefit and impact of programs.
• Manage resourcing of clinical projects within the disease area across the assets in scope including portfolio projects and programs (encompassing early projects prior to candidate selection, through early and late-stage clinical development) and business development/due diligence activities.

• Required:
  
  Medical degree and clinical medical specialty training board qualification/registration in Nephrology.
• Required:
  
  Experience in (bio-)pharmaceutical industry with experience in Nephrology clinical drug development.
• Required:
  
  End-to-end clinical development experience including first-in-human trials & proof of mechanism, Ph2 (proof of concept), and Ph3 (registrational studies).
• Required:
  
  Experience leading regulatory interactions and submissions (pre-IND/IND, scientific advice, end-of-phase 2, pre-NDA/BLA and files, advisory committee meetings).
• Required:
  
  Experience in designing and executing clinical strategies.
• Required:
  
  Experience leading projects that harness digital, technological, and statistical tools to support early-stage programs in Nephrology.
• Required:
  
  Experience in clinical safety and pharmacovigilance, with expertise in evaluation of safety signals, and proactive risk management strategies.
• Required:
  
  Experience with the local and global pharmaceutical industry, competitive landscape, end-to-end drug development and lifecycle management.
• Preferred:
  Experience in navigating, influencing, and championing change in a large, complex, matrixed organization.
• Preferred:
  Knowledge of advanced trial designs (adaptive and platform trials).
• Preferred:
  Energized by delivering ambitious standards through collaboration and motivating others across the organization.
• Preferred:
  Passionate about developing others into future leaders.
• Preferred:
  Ability to think outside of conventional classifications of disease, where appropriate, and utilize cutting-edge translational data (genetic, cellular, or systems biology) to support innovative translational strategies.
• Preferred:
  Experience in leveraging expert knowledge for scientific, technical, clinical, and regulatory forward looking…