Description
At GSK, we are uniting science, technology, and talent to get ahead of disease together. The Evidence Generation Strategy & Operations Lead is responsible for providing DGP process coordination and study/project management, statistic & data management expertise for studies in Japan CPO to ensure the delivery of evidence generation to support launch readiness, pricing, reimbursement, and life cycle management.
Key Responsibilities
- Shape evidence-generation strategy across therapeutic areas and drive cross-portfolio operational synergies.
- Act as leader to enterprise evidence strategy and operations, covering aspects of evidence synthesis, analytics, and study operations to provide coaching and implement internal standards and processes.
- Ensure the timing and quality delivery of studies/projects and organize regular study monitor meetings for dashboard management.
- Ensure study quality standards, i.e., no significant compliance (GCP, SOP, or applicable regulations) issues throughout study planning and execution.
- Redefine processes and ways of working to enable more efficient and effective planning and execution of data-generation programs, standardizing workflows, reducing duplication, and accelerating delivery across the portfolio.
- Responsible for the quality of outsource service through vendor management.
- Maintain effective communication with internal and external stakeholders.
- Proactively identify and drive cross-TA and cross-portfolio synergies (e.g., data reuse, harmonized study designs, shared analytics) to increase efficiency, reduce duplication, and accelerate timelines.
- Represent Japan RWE-HO in cross-regional forums on evidence strategy, ensuring alignment with global RWE-HO initiatives and facilitating two-way knowledge transfer.
- Partner closely with Global RWE-HO to prepare QBRs and townhalls, and to promote best-practice sharing in Japan and across other regions.
Experience and Qualifications
- Advanced degree in a relevant field (e.g., Epidemiology, Biostatistics, Public Health, Life Sciences) preferred.
- Significant experience in real-world evidence, clinical or observational study design, statistical or data management, and study delivery.
- Demonstrated people management and cross-functional leadership skills.
- Experience with vendor management and quality/compliance oversight in regulated environments.
- Strong communication, project management, and problem-solving skills.
- Consulting/CRO managerial experience welcomed.