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Pathos is a next-generation biotech company building AI-powered systems to transform drug development. The company uses foundation models in oncology paired with proprietary AI systems and 200+ petabytes of multimodal data to make development decisions with greater precision earlier in the process. Pathos operates with a lean, high-velocity model: small teams of 2–4 subject matter experts command AI agents to execute work that traditionally required dozens of people. There is no middle management; everyone builds and ships.
The Director of Clinical Data Management will establish and lead the data management function from the ground up, reporting to the Chief Clinical Operations Officer. This is a hands-on leadership role ideal for someone who thrives in fast-moving, high-growth environments.
Key Responsibilities:
Clinical Data Strategy & Oversight: Lead oversight of data management for outsourced clinical trials, including project management, vendor coordination, internal reviews, and data cleaning. Oversee CRO/vendor activities to ensure GCP compliance and adherence to protocols and Standard Operating Procedures. Oversee data management activities across trials: Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation guidelines, edit check programs, data entry and query 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.
Execution & Vendor Management: 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.
Cross-Functional Collaboration: Serve as the primary CDM representative on cross-functional study teams. Partner with Biostatistics, Clinical Operations, Clinical Development, 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.
Leadership & Compliance: 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.
Requirements:
- 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)
- Experience in gathering requirements and preparation of specifications for database systems and integrations (ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc.)
- Knowledge of regulatory and industry standards (ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries)
- 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
