Pathos is building a next-generation biotech with AI at the core, focused on transforming drug development. The Director of Clinical Data Management will establish and lead the clinical data management function, ensuring data integrity and readiness for analysis in oncology trials.
Responsibilities:
- Own clinical data strategy and oversight
- Lead oversight of data management for outsourced clinical trials, including project planning, vendor coordination, internal review cycles, data cleaning, and approval of deliverables
- Oversee CRO and vendor activities to ensure GCP compliance and execution against protocols and SOPs
- Own consistency across trials and programs: CRF design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check specifications, data entry and query status tracking, and database lock
- Drive timely database lock, data quality, and readiness for statistical analysis and regulatory submissions
- Direct AI agents to draft DMPs, edit check specs, and reconciliation reports, and apply your judgment to the final product
- Manage CROs and vendors delivering CDM services, holding them to timelines, budgets, and quality standards
- Develop and monitor Data Management Plans, Data Review Plans, and data transfer specifications
- Resolve complex data issues, queries, and discrepancies in partnership with clinical and statistical teams
- Use AI agents to compare vendor deliverables against specifications, surface drift early, and prepare structured feedback for vendor reviews
- Serve as the primary CDM partner on every study team
- Partner with Biostatistics, Clinical Operations, Medical Monitoring, and Data Science colleagues so that data supports trial endpoints and regulatory deliverables
- Collaborate on the integration of clinical trial data with Pathos AI platforms and real world data sources so that operational data feeds back into model performance and decision support
- Build and scale the CDM function as the company grows, including hiring and mentoring future staff
- Develop SOPs, best practices, and quality frameworks that meet GCP, ICH, CDISC, and 21 CFR Part 11 expectations
- Contribute to portfolio level planning and operational strategy, and translate CDM signals into actionable input for Clinical Operations leadership