VP, Clinical Research Head, Nephrology Therapeutic Area

Role Summary

VP Clinical Research Head (CRH) for Nephrology leads the nephrology portfolio within the Advanced Portfolio Unit of RIIRU, guiding discovery and development across programs and partnering with RIIRU leadership and cross-functional partners to define disease-area strategy, integrated evidence plans, and innovative trials that enable approval, commercialization, and patient access. The role requires significant translational and clinical expertise and operates across a broad matrix with biology, asset/medicine leadership, regulatory, biostatistics, medical affairs, and commercial, with Medical Governance responsibility for clinical programs. On-site presence is required at one of GSK’s US sites (Upper Providence, PA; Waltham, MA) or UK sites (London New Oxford Street; Stevenage).

Responsibilities

• Lead building a portfolio of Nephrology TA programs with potential for differentiation and development tractability, informing investment decisions.
• Deliver the full spectrum of advanced clinical development studies and submissions from Ph1b/2a through filing in nephrology.
• Serve as the single point of accountability for disease-area strategy developed with input from internal leaders, external academic thought leaders, regulatory authorities, investigators, and patient groups.
• Lead milestone transitions from candidate selection to filing/launch, guiding Clinical Leads on optimized strategies and risk-managed pathways.
• Provide Medical Governance with accountability for managing and mentoring clinical staff in the disease-area line, ensuring training and compliance with policies, guidance, laws, and codes.
• Develop and maintain excellence in translational and clinical leadership in Nephrology.
• Ensure the quality of clinical deliverables within the disease area including all documents and submissions through 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), overseeing data strategies and related data-science efforts to benefit programs.
• Manage resourcing of clinical projects across assets in scope including portfolio projects and programs (early to late-stage) and business development/due diligence activities.

Qualifications

• 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 and 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, and end-to-end lifecycle and revenue cycles operate.

Additional Requirements

• On-site presence required at designated US or UK sites (minimum two days per week).