Director, Clinical Research Operations
GeneDx
Google Cloud Platform
VP, Global Head, Platform Sciences
GSK
full-time
Posted on:
Origin: • 🇺🇸 United States • Pennsylvania
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Develop and implement a global strategic vision for the Platform Sciences team in GSK’s Development function.
- Lead a global team of experienced scientific leaders and technical subject matter experts to oversee end-to-end workflow from sample collection, shipment, laboratory testing, to data reporting.
- Engage with senior R&D leaders and collaborate with global cross-functional teams to integrate Platform Sciences into R&D.
- Manage strategic direction and operational execution of biomarker, immunogenicity, and bioanalytical lab assay development and sample testing across medicine modalities from FTIH trials to global filings.
- Partner with CPMS colleagues on Systems and Tools development, deployment and create a community of practice to enable consistency of CPMS in R&D.
- Provide oversight for clinical biomarker operations, lab operational study management and central lab activities globally.
- Implement best practices for biobank operations and HBSM to ensure ethical, compliant, and efficient handling of human biological samples.
- Ensure global compliance with GCP, regulatory requirements, and industry standards for biomarker and bioanalytical research, biobank management, lab operational studies, central lab activities, and HBSM.
- Manage the global budget, resources, and infrastructure for Platform Sciences team, optimizing allocation to meet strategic objectives.
- Report directly to the SVP, Development and engage extensively with Therapeutical Area teams including oncology, respiratory, immunology, inflammation, HIV/infectious diseases, Research Technologies, and other Development groups.
Requirements
- PhD in a scientific field.
- 20+ years of experience in biomarker and bioanalytical sciences, CPMS tools, biomarker operations, biobank management, lab operational study management, central lab oversight, and HBSM in pharmaceutical or private laboratory/drug development global life sciences industry.
- Experience with the drug development process and the application and value of platform sciences in advancing clinical development and project accelerations.
- Experience leading global multidisciplinary, functional, line and matrix teams.
- Experience in GCP, regulatory requirements, and guidelines pertaining to biomarker and bioanalytical research, biobank management, lab operational studies, central lab activities, and HBSM.
- Experience with platform technologies and their application in clinical development.
- Track record of strategic planning and execution in a complex, global organization (preferred).
- Ability to work collaboratively with cross-functional teams and influence stakeholders at all levels (preferred).
- High level of proficiency in organizational strategy and development and strong alignment with R&D objectives (preferred).
- Excellent communication, collaboration, and interpersonal skills (preferred).
- Ability to be on-site office-based 2 to 3 days a week in the UK (Stevenage) or US (Upper Providence, PA).
