Executive Director, Clinical Data Management

Dianthus Therapeutics, Inc.

Executive Director overseeing Clinical Data Management function at Dianthus Therapeutics. Leading strategic development and execution of clinical data management activities in a biotech environment.

Posted 7/30/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Data Management, including leadership in building and scaling teams, ensuring compliance with GCP, ICH, and FDA regulations, and managing relationships with CROs and external partners. Proven ability to drive operational excellence and implement data management systems to enhance efficiency and data quality.

Highest-signal resume keywords

Clinical Data Management LeadershipGCP ComplianceEDC Systems ExpertiseCRO Partnership ManagementRegulatory Submission Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementData Quality AssuranceEDC SystemsCDISC StandardsMedical CodingData IntegrationRegulatory CompliancePhase 2 Clinical ProgramsPhase 3 Clinical ProgramsOperational Excellence

Soft Skills

Team BuildingMentoringCollaborationProblem SolvingInfluencing Leadership

Industry Keywords

BiotechnologyPharmaceuticalCRONDABLAMAAInspection ReadinessGovernance FrameworksQuality StandardsStrategic Relationships

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and scale the Clinical Data Management function, establishing the strategy, organizational structure, and roadmap to support Dianthus' growing clinical portfolio.
Build, develop, and mentor a high-performing team while fostering a culture of accountability, collaboration, innovation, and operational excellence.
Establish and maintain departmental SOPs, processes, governance frameworks, quality standards, and inspection-ready practices.
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 strengthen strategic relationships with CROs, vendors, and external partners, ensuring performance, quality, and operational excellence.
Drive the evaluation, implementation, and optimization of data management systems, technologies, and processes to improve efficiency, scalability, and data quality.
Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, and Quality teams to support study execution, regulatory submissions, and key business decisions.
Ensure compliance with GCP, ICH, FDA, and global regulatory requirements while maintaining inspection readiness and supporting regulatory submissions.
Serve as the Clinical Data Management subject matter expert and leadership representative across cross-functional and senior leadership forums.
Remain actively engaged in study-level execution and problem-solving, balancing strategic leadership with hands-on operational support in a fast-paced biotechnology environment.

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Health Sciences, or related discipline; advanced degree preferred.
15+ years of Clinical Data Management experience within biotechnology, pharmaceutical, or CRO environments.
8+ years of progressive leadership experience managing Clinical Data Management teams and functional operations.
Experience building, scaling, or transforming Clinical Data Management organizations, processes, and operating models.
Demonstrated success supporting Phase 2 and Phase 3 clinical programs.
Strong experience overseeing outsourced data management activities and CRO partnerships.
Comprehensive knowledge of EDC systems, clinical databases, CDISC standards, medical coding, external data integration, and reconciliation processes.
Deep understanding of drug development, GCP, ICH guidelines, and global regulatory requirements.
Experience supporting major regulatory submissions, including NDA, BLA, and/or MAA filings.
Proven ability to influence senior leadership and drive cross-functional alignment in a matrix environment.

Benefits

Comp & perks

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