Position Overview:

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.

Primary Responsibilities:

Program & Study Ownership

• 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; communicate issues early with clear, solution-oriented recommendations.

CRO & Vendor Oversight

• 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 in partnership with the Senior Director of Data Management.

Data Standards, Systems & Process Contribution

• Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models as the organization scales its clinical portfolio.
• 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.

Inspection Readiness

• Support inspection readiness activities across assigned programs, ensuring documentation and data traceability meet regulatory expectations.
• Serve as a key data management participant during audits and inspections, in coordination with the Senior Director and Quality.
• Ensure data management deliverables remain inspection ready throughout the study lifecycle.

Cross-Functional Partnership

• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Regulatory, and Quality.
• Communicate complex data issues clearly and effectively to stakeholders with varying technical backgrounds.
• Build trust as a pragmatic, detail-oriented partner who balances scientific rigor with efficient execution.

Required Qualifications:

• 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.

Preferred Qualifications:

• Experience and knowledge of gene/cell therapy and/or rare disease.
• Prior experience supporting registrational or pre registrational programs.