Senior Manager, Oncology Early Stage Clinical Scientist
Pfizer
Google Cloud Platform
Senior Principal Clinical Research Scientist
GRAIL
full-time
Posted on:
Location: California • 🇺🇸 United States
Visit company websiteSalary
💰 $211,000 - $281,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Conceptualization, design, implementation and analysis of clinical evidence generation studies
- Lead cross-functional teams on design, conduct and analysis of clinical studies with academic, community, and industry partners
- Design and implement approaches to review, clean, analyze and integrate large and complex clinical datasets
- Lead regular and ad-hoc data reviews and interpretation of clinical data; prepare and present summaries/documentations
- Oversee data quality review activities and resolve data quality issues
- Lead strategic efforts to advance clinical development and scientific plans; engage key opinion leaders; provide expert scientific input
- Contribute to development of data collection forms and data/metadata standards
- Collaborate with Biostatistics to develop statistical analysis plans and co-author clinical study reports
- Represent Clinical Science as thought leader on cross-functional teams
- Ensure data integrity and quality, appropriate blinding and data privacy standards
- Develop electronic case report forms and other clinical data capture methods
- Lead development of study reports, presentations, and publications
- Conduct literature reviews and obtain external data (e.g., SEER, US Census) to inform or interpret study results
- Develop formal networks with external investigators and thought leaders
- Ensure compliance with industry regulations, policies, guidelines and standards
Requirements
- Advanced clinical/scientific degree (e.g. PharmD, PhD, MSN, MPH)
- at least 5 years of oncology clinical and/or population science research experience (with advanced degree)
- Minimum 10 years of experience working in industry
- deep experience in cancer epidemiology, especially 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 with substantial peer-reviewed publications
- Strong track record in data management and integrating complex, large-scale datasets
- Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
- Demonstrated ability to initiate and maintain effective relationships with internal and external collaborators
- Demonstrated ability to lead cross-functional teams
- Excellent interpersonal communication (written and verbal), presentation and organizational skills
- Excellent team player with demonstrated track record of success in a fast-pace cross-functional team environment
- Consistent commitment to delivering on team goals with a sense of shared purpose
