Pathos · 16 hours ago
Director of Clinical Data Management
United States
Full-time
Remote
Director/Executive
10+ years expPathos is building a next-generation biotech with AI at the core, focused on transforming drug development. The Director of Clinical Data Management will lead the data management function, ensuring high-quality data collection and integrity across oncology trials.
Artificial Intelligence (AI)BiotechnologyLife ScienceMedicalTherapeutics
Responsibilities
Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews and data cleaning process, and approval of deliverables
Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices
Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure
Ensure timely database lock, data quality, and readiness for statistical analysis and regulatory submissions
Drive adoption of modern, scalable data management tools and workflows
Manage CROs and vendors delivering CDM services, ensuring compliance with timelines, budgets, and quality standards
Develop and monitor CDM plans, including Data Management Plans (DMPs), Data Review Plans (DRPs), and data transfer specifications
Resolve complex data issues, queries, and discrepancies in collaboration with clinical and statistical teams
Serve as the primary CDM representative on cross-functional study teams
Partner with Biostatistics, Clinical Operations, Medical Monitoring, and Data Science colleagues to ensure data supports trial endpoints and regulatory deliverables
Collaborate on integration of clinical trial data with Pathos’ AI/ML platforms and real-world data sources
Build and scale the CDM function, including hiring and mentoring staff
Develop SOPs, best practices, and quality frameworks to ensure compliance with GCP, ICH, and regulatory requirements
Contribute to portfolio-level planning and operational strategy
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Data Management, or related field
10+ years of progressive experience in clinical data management, including leadership in oncology trials
Deep knowledge of EDC systems (e.g., Medidata Rave, Veeva CDMS, Oracle InForm) and clinical data standards (CDISC, SDTM, ADaM)
Knowledge of regulatory and industry standards (e.g. ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries etc.) and their application to Data Management practice
Preferred
Experience in gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc. would be highly regarded
Prior experience filing a NDA/MAA/BLA preferred
Experience managing CROs/vendors and building CDM functions preferred
Proven ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
Company
Pathos
Pathos is a biotechnology company that leverages AI to accelerate oncology drug development.
11-50 employees
H1B Sponsorship
Pathos has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
Funding
Current Stage
Late StageTotal Funding
$447MKey Investors
New Enterprise Associates
2025-05-15Series D· $365M
2024-10-29Series C· $62M
2023-03-02Series Unknown· $20M
Leadership Team
Ryan Fukushima
Co-Founder
Recent News
2025-10-27
2025-09-19
Company data provided by crunchbase