Insmed Incorporated · 1 month ago
Head of Clinical Data Management
United States
Full-time
Remote
Director/Executive
$255K/yr - $348K/yr
12+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Head of Clinical Data Management will oversee all aspects of Clinical Data Management across the development portfolio, ensuring high-quality, inspection-ready clinical data and leading a high-performing Data Management organization.
BiotechnologyHealthcarePharmaceuticalMedical
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
Qualification
Required
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
Preferred
Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs is preferred
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
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
81%
Represents job field similar to this job
Engineering and Development
Management and Executive
Marketing
Trends of Total Sponsorships
*2026 (9)
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
K
Kevin Tully
Executive Vice President and Chief Financial Officer
Roger Adsett
Chief Operating Officer
Recent News
BioWorld Financial Watch
2026-07-18
Company data provided by crunchbase