GSK is a global healthcare and pharmaceutical company that combines scientific research, technology, and specialist talent to develop medicines and vaccines. Its work spans the discovery, production, and delivery of products designed to help prevent and manage disease, offering opportunities to contribute to healthcare innovation within a large, international organization.
Senior Director, CMC Report Transformation at GSK (Hybrid, UK)
Lead GSK’s CMC regulatory report transformation portfolio, including AI-enabled technical report automation, governance, and value delivery. Drive report transformation across global drug development and supply.
Description
- Oversee strategy and long-term planning for the CMC report transformation product portfolio
- Own the product roadmap, investment sequencing, and delivery priorities to maximise scientific and business value
- Set enterprise priorities across competing demands and make evidence-based trade-offs
- Provide end-to-end technical accountability for report transformation products and strategy
- Ensure solutions are architecturally robust, performant, validated, and suitable for regulated CMC use
- Manage people, budgets, delivery resources, senior hiring, and organisational design decisions
- Engage stakeholders across scientific, technical, quality, and executive leadership groups
- Build alignment and sponsorship for agentic AI initiatives
- Measure and communicate the value and impact of report transformation products
- Coordinate stakeholders across DDS, Regulatory, Digital & Tech, and Quality organisations
- Build, lead, and develop a high-performing product and technical leadership team
- Serve as the senior executive sponsor for CMC report transformation
- Represent the function in VP and senior leadership forums while shaping enterprise digital and AI strategy
Requirements
- Bachelor’s degree in computer science, data science, engineering, life sciences, regulatory affairs, or a closely related scientific or technical discipline
- Background in product management and leadership, with experience delivering data, software, and AI/ML products
- Experience working at director level or higher
- Extensive experience defining enterprise strategy for and delivering complex, production-grade AI products
- Experience applying agentic or autonomous AI in scientific, healthcare, or pharmaceutical CMC settings
- Hands-on experience automating regulatory or technical report writing and documentation through digital tools or AI
- Working knowledge of GxP computerised system validation principles, including GAMP 5
- Familiarity with CMC regulatory report types and submission formats, including eCTD Module 3
- Practical understanding of NLG, LLM, and structured or templated authoring technologies
- Familiarity with ICH, FDA, and EMA guidance concerning automation and AI in regulated content
- Experience with electronic quality and document management systems, such as VQD
- Working knowledge of data privacy, information security, and intellectual property issues affecting AI tools in life sciences
- Experience holding technical accountability for production technology products
- Experience assessing, integrating, and governing third-party AI and data platforms and partnerships
- Understanding of the CMC development and manufacturing lifecycle
- Familiarity with agile and product delivery approaches, including Scrum and SAFe
- Proven success building, leading, and developing high-performing teams and senior talent in a large, matrixed global organisation
Benefits
- An annual bonus may be available
- Eligibility to participate in a share-based long-term incentive programme
- Hybrid working combining on-site and remote work
- Agile working practices with opportunities for flexibility
- Recruitment process adjustments are available for applicants who need them