Vice President, Medicine Development Leader

Overview

GSK is seeking a highly skilled Vice President, Medicine Development Leader (MDL), to strategically lead the optimal global development of a renal medicine at an asset level, acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s).

By working with stakeholders across GSK's Medicine Development matrix (R&D, Manufacturing, Commercial, etc.), you will define the strategic vision and operational plan for the medicine, align it with the organizational strategy, and create and lead the matrixed Medicine Development Team (MDT), representing the disciplines required to deliver development including Clinical Development, Medical, Commercial and Manufacturing, amongst others. The MDL reports to the SVP & Head Advanced Pipeline Unit - Respiratory, Immunology and Inflammation Research Unit.

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease. The remit is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external and internal partnerships.

PLEASE NOTE:

This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's US (PA or MA) or UK (London - New Oxford Street or Stevenage) sites.

• Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from PoC to Approval in all major markets
• Work with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of lead indication(s) from PoC to Approval
• Post-approval, support the Medicine Commercial Team (MCT) in major markets ensuring MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and Life Cycle Management (LCM)
• Select MDT members and lead the multi-disciplinary matrix team, supporting differentiated development for team members and driving MDT performance
• Partner with the Pipeline Project Manager (PPM) to energize the MDT and deliver project objectives, including options for acceleration and smart risk-taking
• Partner with R&D Business Development to lead development planning for a prospective in-licensed asset, including clinical feasibility, regulatory planning and CMC risk mitigation
• Leads the cross-functional MDT to:
  • Establish a compelling vision and Target Medicine Profile (TMP)
  • Deliver differentiated medicines of value for patients, regulators and markets
  • Prioritize development options including multiple indications
  • Develop indication expansion and LCM plans
  • Make evidence-based go / no go / accelerate decisions at inflection points
  • Ensure excellence in governance processes and oversight of studies, safety, pharmacovigilance and promotional practices
  • Incorporate patient voice into development plans
  • Increase visibility to external communities to address unmet medical needs
• Embed core processes including cost efficiency, technology adoption, risk management and policy compliance
• Engage with internal and external stakeholders to promote organizational reputation and asset value
• Ensure quality and compliance oversight in line with R&D expectations and project needs; ensure data and science quality
• Serve as the asset's single point of contact and spokesperson to Senior Management and governance bodies
• Deliver and manage the asset resourcing plan (people and finances) and budget variance in collaboration with the PPM and Finance partner

• Advanced degree including MD, PhD, Pharm
  
  D, MBA, MS
• Drug development expertise in global pharmaceutical/biotechnology industry
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Experience across Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial within the R&D/Commercial lifecycle
• Experience in product development and/or commercialization, in late phase development, clinical trial management, post-approval studies, regulatory and…