Diagnostic Execution

Head of Diagnostic Execution

The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine (OTM) is a dedicated group of scientific operations professionals that drive the implementation of clinical diagnostic strategy for therapeutic programs in early and late-stage Oncology clinical development. The team leverages subject matter expertise to progress Dx activities and deliverables in collaboration with Diagnostic (Dx) strategy leads, Clinical Biomarkers (BMx), Precision Medicine & Digital Health Regulatory, Clinical Operations, Human Biological Sample Management, Data Management, Quality, Procurement, and Finance, as well as external CRO laboratories, central laboratories, collaborators, and Dx manufacturers. The team oversees implementation of clinical trial assays at reference labs and centralized testing vendors through contract execution and vendor oversight, ensures integration of relevant Dx content in clinical study documents and associated systems (i.e. clinical protocol, informed consent forms, eCRFs, CSRs, etc.), manages HBS and logistics to support the clinical trial schedule, ensures data is ready for analysis per timeline and oversees data transfer, and resolves or escalates Dx study-related issues.

The Head of Diagnostic Execution is accountable for leading this highly skilled technical team of Dx Delivery professionals, with responsibility for line management, training, oversight and retention, ensuring the team is resourced and trained to manage their accountabilities effectively. In addition, the successful candidate will be experienced in facilitating therapeutic product and / or Dx co-development, project management, scenario planning, budgeting, HBS management, and managing external vendors and partners.

Key Responsibilities

• Lead a team of diagnostic operations professionals to implement clinical biomarker and diagnostic plans for therapeutic programs in early and late-stage clinical development
• Line management, training, oversight, and retention of diagnostic operations professionals
• Maintain knowledge of the science, technology, portfolio, and strategy of R&D across Oncology and deliver high-quality diagnostic operations support
• Engage with and influence leaders and cross-functional stakeholders to develop diagnostic operational strategies by leveraging broad knowledge of biomarker technologies, diagnostic development, and IVD expertise
• Apply and adhere to ICH / GCP, HBS management best practices, regulatory guidelines, ethical guidelines, and technical and industry standards during all aspects of work, ensuring inspection readiness by ensuring preparedness and compliance; support team members in connection with inspections and audits
• Lead functional process and system improvements to ensure operational excellence and identify and build the capability required within the team to ensure deliverables and objectives are successfully met
• Work with stakeholders to improve cross-functional processes GSK
• Represent the Dx Planning & Execution department internally and externally in meetings and discussions as required, and ensure representation of the Dx Delivery team during cross-functional workstreams
• Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels by role modelling the GSK values

Basic Qualifications

Preferred Qualifications