Executive Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and enhance the Clinical Data Management function by creating the strategy, organizational structure, and roadmap to support Dianthus' expanding clinical portfolio.

• Develop, build, and mentor a high-performing team while promoting a culture of accountability, collaboration, innovation, and operational excellence.

• Establish and uphold departmental SOPs, processes, governance frameworks, quality standards, and practices that are inspection-ready.

• Provide leadership and oversight for all data management activities across clinical studies, ensuring the delivery of high-quality, complete, and regulatory-compliant data.

• Manage and enhance strategic relationships with CROs, vendors, and external partners, ensuring performance, quality, and operational excellence.

• Drive the assessment, implementation, and optimization of data management systems, technologies, and processes to enhance efficiency, scalability, and data quality.

• Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, and Quality teams to support study execution, regulatory submissions, and critical business decisions.

• Ensure adherence to GCP, ICH, FDA, and global regulatory standards while maintaining readiness for inspections and supporting regulatory submissions.

• Act as the Clinical Data Management subject matter expert and leadership representative in cross-functional and senior leadership forums.

• Stay actively engaged in study-level execution and problem-solving, balancing strategic leadership with hands-on operational support in a dynamic biotechnology environment.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Health Sciences, or a related field; advanced degree is preferred.

• Over 15 years of experience in Clinical Data Management within biotechnology, pharmaceutical, or CRO settings.

• More than 8 years of progressive leadership experience managing Clinical Data Management teams and functional operations.

• Proven experience in building, scaling, or transforming Clinical Data Management organizations, processes, and operational models.

• Demonstrated success in supporting Phase 2 and Phase 3 clinical programs.

• Strong background in overseeing outsourced data management activities and CRO partnerships.

• Extensive knowledge of EDC systems, clinical databases, CDISC standards, medical coding, external data integration, and reconciliation processes.

• In-depth understanding of drug development, GCP, ICH guidelines, and global regulatory requirements.

• Experience in supporting significant regulatory submissions, including NDA, BLA, and/or MAA filings.

• Proven capability to influence senior leadership and drive cross-functional alignment within a matrix environment.

🏝️ Benefits

• None specified