Head of Clinical Data Management
Insmed Incorporated
August 20, 2026
Remote
United States
Clinical Research and Development
Head of Clinical Data Management
Responsibilities:
- Oversee all Clinical Data Management across the development portfolio from early development through regulatory submissions and post-marketing.
- Ensure strategy, quality, consistency, and delivery of data management activities (CRF/eCRF design, database build/validation, edit checks, data review/cleaning, integrations/reconciliations, medical coding, query management, database lock, submission readiness).
- Build, develop, and lead a high-performing Data Management organization; set priorities, evaluate performance, develop talent, and manage resourcing.
- Establish quality control and risk mitigation; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support audits.
- Provide strategic leadership for data management systems/technologies, automation, and innovation in a validated GxP environment.
- Lead initiatives for operational excellence, standardization, inspection readiness, and continuous improvement.
- Modernize processes (data integration/reconciliation, centralized/risk-based review, automation/AI-enabled workflows, metadata-driven processes, data interoperability).
- Partner with Programming, Biostatistics, IT, and Digital; represent Data Management in cross-functional/enterprise forums.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, Data Science, Statistics, or related; 12+ years progressive Clinical Data Management experience in pharma/biotech.
- 8+ years leadership experience across teams/complex portfolios.
- Deep knowledge of clinical trial data lifecycle, GCP, global regulatory requirements, CDISC standards, EDC, external data integrations, database lock, and inspection readiness.
- Experience leading Phase 2/3 global clinical trials and regulatory submission support (NDA/BLA/MAA/PMDA and global filings) plus health authority inspections.
- Experience with modern clinical data technologies, automation/digital transformation in validated GxP.
- Vendor oversight/CRO partnership experience.
- Strong strategic thinking, operational execution, cross-functional influence, and communication.
Preferred:
- Rare disease, respiratory, immunology, gene therapy, or specialty biotech experience.
- Master’s or PhD in relevant field.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities:
- Oversee all Clinical Data Management across the development portfolio from early development through regulatory submissions and post-marketing.
- Ensure strategy, quality, consistency, and delivery of data management activities (CRF/eCRF design, database build/validation, edit checks, data review/cleaning, integrations/reconciliations, medical coding, query management, database lock, submission readiness).
- Build, develop, and lead a high-performing Data Management organization; set priorities, evaluate performance, develop talent, and manage resourcing.
- Establish quality control and risk mitigation; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support audits.
- Provide strategic leadership for data management systems/technologies, automation, and innovation in a validated GxP environment.
- Lead initiatives for operational excellence, standardization, inspection readiness, and continuous improvement.
- Modernize processes (data integration/reconciliation, centralized/risk-based review, automation/AI-enabled workflows, metadata-driven processes, data interoperability).
- Partner with Programming, Biostatistics, IT, and Digital; represent Data Management in cross-functional/enterprise forums.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, Data Science, Statistics, or related; 12+ years progressive Clinical Data Management experience in pharma/biotech.
- 8+ years leadership experience across teams/complex portfolios.
- Deep knowledge of clinical trial data lifecycle, GCP, global regulatory requirements, CDISC standards, EDC, external data integrations, database lock, and inspection readiness.
- Experience leading Phase 2/3 global clinical trials and regulatory submission support (NDA/BLA/MAA/PMDA and global filings) plus health authority inspections.
- Experience with modern clinical data technologies, automation/digital transformation in validated GxP.
- Vendor oversight/CRO partnership experience.
- Strong strategic thinking, operational execution, cross-functional influence, and communication.
Preferred:
- Rare disease, respiratory, immunology, gene therapy, or specialty biotech experience.
- Master’s or PhD in relevant field.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.