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Reporting to the Senior Director, Clinical Data Management, the Associate Director / Director, Clinical Data Management will serve as the dedicated data management lead for our Liver franchise. Initially supporting a single study within the program, this individual will grow with the franchise as it expands to include additional studies within the same program and, ultimately, other programs across the franchise portfolio. This role offers a unique blend of hands-on study oversight and strategic leadership, making it an ideal opportunity for a candidate who thrives at the intersection of execution and innovation, in a fast‑paced biotech environment where clarity, quality, and collaboration are critical. This is a highly visible role working cross‑functionally with Clinical Development, Biostatistics, Statistical Programming, Regulatory, Quality, and external partners to ensure data integrity, inspection readiness, and timely delivery of data supporting key development and regulatory milestones.
Job Responsibility:
Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml
Support inspection readiness activities across assigned programs
Serve as a key data management participant during audits and inspections
Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Regulatory, and Quality
Communicate complex data issues clearly and effectively to stakeholders
Requirements:
BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization
Nice to have:
Experience and knowledge of gene/cell therapy and/or rare disease
Prior experience supporting registrational or pre registrational programs