GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. They are using next-generation sequencing (NGS), population-scale clinical studies, and computer science and data science to overcome challenges in cancer care. The Senior Principal Clinical Scientist will support the development and implementation of clinical development strategies at GRAIL.
Requirements
- Advanced clinical/scientific degree (e.g. PharmD, PhD, MSN, MPH)with at least 5 years of oncology clinical and/or population science research experience
- Minimum 10 years of experience working in industry, including deep experience in cancer epidemiology, especially as it relates to screening and early detection
- Extensive experience with SEER or other population-based cancer registry data
- Significant experience in designing and conducting clinical and/or real-world evidence studies, particularly registrational and/or clinical utility studies for reimbursement
- Extensive experience in scientific communication as demonstrated by substantial number of peer-reviewed publications
- Strong track record in data management and integrating complex, large-scale datasets.
- Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
Responsibilities
- Lead cross-functional teams that include key functional stakeholders on the design, conduct and analysis of clinical studies conducted with GRAIL’s academic, community, and industry partners
- Design and implement systematic approaches to review, clean, analyze and integrate large and complex clinical datasets from one or more large clinical studies
- Lead regular and ad-hoc data reviews and interpretation of clinical data; prepare and present summaries/documentations of these reviews to share with cross-functional teams
- Oversee data quality review activities and efforts to resolve data quality issues.
- Lead strategic efforts to advance the clinical development and scientific plans (review and interpretation of study data; engagement of key opinion leaders; providing expert scientific input to study-level and program-level teams)
- Contribute to development of data collection forms and data/metadata standards to support clinical studies and pooled data analyses
- Collaborate with colleagues from Biostatistics to develop statistical analysis plans and serve as a co-author on clinical study reports and other study deliverables
Other
- Provide strategic leadership for cross-functional teams.
- Represent Clinical Science as a strategic thought leader on cross-functional project teams with goals of building and deploying systematic approaches for data review, cleaning and analyses
- Contribute to methods to ensure data integrity and quality throughout the product development lifecycle, ensuring appropriate blinding and data privacy standards are followed.
- Develop electronic case report forms and other clinical data capture methods for clinical data acquisition and study subject follow-upLead the development of study reports, presentations, and publications of studies in collaboration with cross-functional colleagues
- Demonstrated ability to initiate and maintain effective relationships with internal and external collaborators
