VP, CMC Lead mRNA

VP, CMC Lead mRNA

Position Summary

The VP, CMC Lead mRNA leads a team of CMC leaders and is accountable for the effective leadership of the team and their delivery of process and product development, from commit to candidate to launch, including innovative technology implementation, technology transfer, registration.  

Reporting to the Head of Vaccines Technical R&D, this strategic role is accountable for success of GSK’s end to end mRNA strategy and is a highly visible position, aligning with the highest level of the organisation to ensure product development and portfolio delivery.

Key Responsibilities

• Effective CMC leadership of all mRNA assets, from commit to candidate to launch. It also includes recruiting, developing and guiding CMC leaders, working with product and process development experts to ensure that the proposed product, innovative technology, manufacturing processes and supply chain logistics are sufficient to support clinical trials, transfer to manufacturing site, registration and launch of the product   

• Works with CMOs/internal sites to ensure that manufacturing sites and associated logistics are capable of implementing the manufacturing process and supply chain to produce quality product for clinical studies, registration activities and initial commercial supply;  

• Leads the assessment of technical, regulatory, quality, logistical and financial risks associated with the physical product development, manufacture and supply;   

• Works with GSK leaders in commercial manufacturing and logistics (GSC), therapeutic areas, franchises and R&D new mRNA platforms to ensure well developed product lifecycle plans with clarity on the activities, technologies and resources/capabilities required;   

• Timely governance and investment, aligned with therapeutic area and platform development strategy, for progression of mRNA vaccines assets through major lifecycle programs  

• Accountable for effective peer review of mRNA project plans and governance papers  

• Responsible for robust CMC plans across mRNA portfolio, including maturity increase, expertise building in R&D and GSC, that inform governance decisions on investment progression.  

• Define, develop and implement the GSK processes that guide and govern delivery of GSK’s new mRNA technology assets through all stages of development, launch and initial commercial batches production, working directly with the CMC Development Board and relevant peer review bodies to ensure the best project plans are enabled.   

• Develop and implement a workforce plan that is aligned to current and future needs of the mRNA portfolio and the business and that reflects a diverse and high performing workforce. Work with internal and external partners to establish and develop a pipeline of future CMC Matrix leaders and career development opportunities for existing CMC Matrix leaders.  

• Keep abreast of business, regulatory and technology trends emerging from GSK, academia, external industry and regulators that are relevant to the development and supply of mRNA assets and ensure that GSK and/or CMOs are building appropriate capability for clinical supplies and eventual commercial production.    

• Ensure alignment with R&D, commercial manufacturing and external partners to enable effective and efficient delivery of mRNA portfolio. This will include providing an aligned CMC portfolio view to share with CMC partners and ensuring a well-integrated ‘one-CMC-matrix-team’ and a seamless interface between CMC and the project teams, CMC Matrix Leaders, Vaccines Development Leaders, Commercialization Leaders, project managers, the commercial supply chain and logistics organizations and the manufacturing sites, the therapeutic area and Franchise groups, the Local Operating Companies and external partners.   

• Core member of Vx Technical R&D Leadership Team contributing to organizational strategy and goals, the development of leaders of the future and the tactics associated with the CMC aspects of development and supply of mRNA assets.   

• Create an environment where teaching and learning, empowerment and tiered accountability are core to the ways of working within the team.  

• Resolve cross-project conflicts and risks that impact the delivery of mRNA portfolio; develop and implement effective strategies to ensure cross-portfolio problems are resolved.   

• Serve as the portfolio interface to one or more of the following: Viral Scientific Area, Therapeutic SA, bacterial SA, Medicines and/or franchise heads.  In this role, provide input to partners regarding to cross-portfolio delivery, strategy, and l