VP, CMC Project Leadership, Small Molecules

GSK

18h•Hybrid

About The Position

The VP, CMC Project Leadership, Small Molecules, leads a team of CMC Development & Industrialisation Leaders and is accountable for the effective leadership of the team and their delivery of process and product development (starting from preparation for Phase 2 through to post‑launch), supply chain and logistics definition, technology transfer, registration, launch of commercial supply, lifecycle program delivery, and market expansion for GSK’s small molecule/synthetic projects.

Requirements

BSc in chemistry, life sciences, or bio(chemical) engineering.
Extensive CMC experience in the development or manufacture of small / synthetic molecules and drug products.
Experience in CMC, supply chain, and late phase CMC/supply‑chain development and commercialization.
Project leadership experience, specifically leadership of global multi‑disciplinary, matrix teams.
Experience developing and bringing medicines to market, having delivered a product through the technology transfer process in some capacity.
Experience with global pharmaceutical CMC regulatory requirements and working at a very senior level with both internal and external groups.

Nice To Haves

PhD or EngD.
Additional CMC experience in the development or manufacture of biopharmaceuticals or vaccines.
An influential and collaborative leader.
Learning agility and desire to learn new things outside of one's comfort zone. Willingness to take on diverse and agnostic assignments in product development.
A track record of developing others at director level or above.

Responsibilities

Effective CMC leadership of small molecule assets, from commit‑to‑medicine development through post‑launch, including recruiting, developing and guiding Medicine Development & Industrialisation CMC Matrix Leaders; working with product and process development experts to ensure that the proposed product, manufacturing processes and supply chain logistics are sufficient to support clinical trials, transfer to manufacturing sites, registration and launch of the product; and the delivery of critical lifecycle programmes.
Works with internal sites and CMOs 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, therapeutic areas, franchises and R&D 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 small molecule assets through major lifecycle programmes.
Accountable for effective peer review of all small molecule project plans and governance papers.
Responsible for robust CMC plans across the small molecule portfolio, including diligences, that inform governance decisions on investment progression.
Develops and maintains the GSK processes that guide and govern delivery of GSK’s small molecule assets through all stages of development from Phase 2 onwards, launch and initial commercial supply, working directly with the CMC Development Board and relevant peer review bodies to ensure the best project plans are enabled.
Develops, maintains and implements a workforce plan that is aligned to current and future needs of the products, the portfolio and the business and that reflects a diverse and high‑performing workforce. Works 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.
Keeps abreast of business, regulatory and technology trends emerging from GSK, academia, external industry and regulators that are relevant to the development and supply of small molecules and ensures that GSK and/or CMOs are building appropriate capability for clinical supplies and eventual commercial production.
Ensures alignment with R&D, commercial manufacturing and external partners to enable effective and efficient delivery of the small molecule portfolio. This includes 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; Medicine Commercialisation Leaders; project managers; the commercial supply chain and logistics organisations; manufacturing sites; Therapeutic Area and Franchise groups; Local Operating Companies; and external partners.
Core member of the Medicine and Vaccine Development & Industrialisation (MVD&I) Leadership Team contributing to organisational strategy and goals, the development of leaders of the future, and the tactics associated with the CMC aspects of development and supply of medicines.
Creates an environment where teaching and learning, empowerment and tiered accountability are core to the ways of working within the team.
Resolves cross‑project conflicts and risks that impact the delivery of the speciality small molecule portfolio; develops and implements effective strategies to ensure cross‑portfolio problems are resolved.
Serves as the portfolio interface to one or more of the following: Oncology, Specialty, ViiV, Generalised Medicines Development, and/or Franchise Heads. In this role, provide input to partners regarding cross-portfolio delivery, strategy, and line-specific decision-making forums.
Each leader reporting to this role is responsible for managing a lifecycle EPE (Estimated Project Expenditure) budget – spanning approximately 5 to 10 years – of over £30M per asset. Their responsibilities also include overseeing assets with peak year sales exceeding £500M. In addition, they lead a matrix team of around 10 people, who themselves manage line teams dedicated to specific projects.