[Remote] Head of Clinical Data Management
Note: The job is a remote job and is open to candidates in USA. Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking a Head of Clinical Data Management to oversee all aspects of Clinical Data Management, ensuring the quality and delivery of data management activities while advancing modern data capabilities and operational excellence.
Responsibilities
- Be accountable for the quality, consistency, and strategic delivery of all data management activities across the portfolio, including CRF/eCRF design, database build and validation, edit check specifications, data review and cleaning, external data integrations and reconciliations, medical coding, query management, database lock activities, and submission readiness
- Build, develop, and lead a high-performing Data Management organization with strong operational expertise and leadership bench strength; set priorities, conduct performance evaluations, drive talent development, and oversee resource planning and allocation
- Establish and maintain robust quality control and risk mitigation frameworks; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support regulatory interactions and audits
- Provide strategic leadership for data management systems, technologies, automation, and innovation initiatives to build scalable, compliant, and future-ready data capabilities within a validated GxP environment
- Lead strategic departmental initiatives to strengthen operational excellence, standardization, inspection readiness, and continuous improvement across the Data Management organization
- Lead modernization initiatives across data management processes and capabilities, including areas such as data integration and reconciliation, centralized and risk-based data review, automation, AI-enabled workflows, metadata-driven processes, and data interoperability
- Partner closely with Programming, Biostatistics, IT, and Digital teams to advance integrated data and analytics ecosystems
- Foster strong collaboration within Biometrics and across functions; represent Data Management in key cross-functional forums and enterprise initiatives
Skills
- Master's degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a related discipline
- 12+ years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry
- 8+ years of leadership experience managing teams, functions, and complex development portfolios
- Deep understanding of the clinical trial data lifecycle, clinical data management processes, GCP and global regulatory requirements, CDISC standards, EDC systems, external data integrations, database lock processes, and inspection readiness expectations
- Demonstrated experience leading Data Management activities for Phase 2 and Phase 3 global clinical trials, including support for regulatory submissions (NDA/BLA/MAA/PMDA and global filings) and health authority inspections
- Proven experience with modern clinical data technologies, automation, digital transformation, and innovation initiatives, including building or modernizing data management capabilities, processes, and infrastructure within a validated GxP environment
- Strong experience with vendor oversight, outsourcing models, and global CRO partnerships
- Demonstrated ability to build high-performing teams and maintain high standards of quality, accountability, and operational excellence
- Strong strategic thinking, operational execution capabilities, and cross-functional leadership and influence
- Excellent communication, leadership, problem-solving, and organizational change management skills
- Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Company Overview
Company H1B Sponsorship