Director Non-Interventional Studies; NIS Planning & Delivery FSP Partnerships
Listed on 2025-12-07
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IT/Tech
Data Science Manager
Company Overview
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.
GSK has kicked off 2025 with impressive growth in sales, profits, and earnings. We anticipate five major new FDA product approvals and 15 phase III/pivotal study readouts over the next two years. So far, we have secured two FDA approvals, with three more expected later this year. By uniting science, technology, and talent, we are committed to getting ahead of disease together.
Purpose
GSK is seeking an experienced leader to support the Non‑Interventional Studies Planning & Delivery Study Delivery Leadership Team on implementing and executing the oversight on Study Delivery FSP resourcing strategies with third parties within the NIS P&D organisation. This role is fully accountable for managing the overall delivery, cost and quality of projects and contracts assigned to meet organisational expectations, to enable efficient and cost‑effective delivery of NIS P&D Study Delivery FSP resourcing model for the NIS P&D organisation.
Management of the budget to meet the relevant budget targets and ensure it is in line with the wider clinical operations targets.
- Lead and manage the operationalization of the NIS P&D Study Delivery FSP model, ensuring strategic oversight, governance, and continuous improvement in collaboration with internal and external stakeholders.
- Oversee design, implementation, and transition to the FSP operating model.
- Build and maintain strong partnerships with FSP vendors for seamless program delivery.
- Drive process improvements and strategic enhancements to FSP models.
- Ensure compliance with governance frameworks, contracts, and financial controls.
- Liaise with Procurement, HR, Legal, Finance, and CRO managers to align with business expectations.
- Monitor KPIs, risks, and cost‑saving measures; elevate issues through governance structures.
- Act as primary liaison for issue resolution across processes, countries, and study‑level concerns.
- Provide operational guidance on systems onboarding, training, and WoWs.
- Implement initiatives to improve study delivery performance and team capability.
- Serve as business owner for all FSP services, including budget oversight and legal documentation.
- Bachelor’s degree or equivalent in General Science or Life/Health related Science Degree.
- Extensive experience in managing clinical operations with strong knowledge and experience of Non‑Interventional Studies (NIS).
- In‑depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
- Experience in People Management and management of resources from different sources in different locations (internal, external, functional service providers).
- Experience in management of Third Parties.
- Advanced degree in General Science or Life/Health related Science Degree.
- Excellent knowledge and understanding of clinical operations and activities associated to study delivery.
- Excellent knowledge of ICH‑GCP and Regulations.
- Knowledge of Industry and CRO world. Experience working with functional service providers.
- Excellent customer orientation, ability to work beyond silos with a strong service provider mindset.
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and…
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