Operations Science Leader
The OSL(Operation Science Leader) is accountable for ensuring delivery of the clinical development plans within the IIDPH. The OSL is accountable for the leadership, management and development of the clinical research team for scientific excellence, operational implementation and data management. The OSL will work closely with the MDL, PPL, PM, CIL, project teams and other key stakeholder to ensure delivery of the R&D strategy.
• Accountable for ensuring effective China study implementation at the project level
• Collaboration with key stakeholder within the TA and PCPS to plan and implement resourcing strategy to address asset/study program requirement, timelines and changing workloads
• Ensure successful progression of the development of new innovative medicines across the IIDPH portfolio including contribution to the regulatory submission and approval, reimbursable medicines and life cycle management including medical affairs
• Identification and sharing of best practices with oversight for the implementation of these best practices into business processes
• Build strong partnership with other stakeholders in the ID TAU, and matrix departments for in-stream, end to end process flow, document preparation, data review (clinical/in stream data review)
• Insurance of the highest quality including inspection readiness and adherence to high standard of GSK (following the SOP of GSK)
• Study delivery encompassing all elements from patient recruitment through Data Capture, to providing a quality assured database ready for analysis and reporting.
• Manages China study teams to deliver the phase I-III clinical trials to support the development and registration of their project.
• Sets project strategy related to clinical and operations activities including data management but not limited to, recruitment strategy, Data Acquisition strategy, Data standards, technical and patient feasibility, resourcing strategy, Customer and supplier relationships relating to Clinical Studies.
• A BA/BSc/PhD/Pharm D or Masters degree in the life sciences with experience in clinical research in the pharmaceutical industry
• A PhD/Pharm D or Masters degree in the life sciences with experience in clinical research in the pharmaceutical industry
• 7+ years of drug development experience including clinical development experience
• Previous relevant pharmaceutical experience is required
• Record of success in positions of increasing responsibilities in study execution (includes scientists, study managers, CSS/CSA and data managers)
• Advanced understanding of drug development processes and key operational interfaces
• Infectious Diseases clinical development experience
The ID TAU strategy has evolved significantly and our pipeline activities have increased drastically over the last 7 years. These events have put pressure on our development organization and require a more diverse organization with deeper scientific content and a diverse talent base. A comprehensive strategy has been developed by ID TAU LT. Core to this is the creation of a clinical development organization within our newly formed Institute for Infectious Diseases and Public Health (IIDPH) which will be based in Beijing, China.
You may apply for this position online by selecting the Apply now button.
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