About the Role:
We're looking for a Head of Clinical Data Management to help us expand what's possible for patients with serious diseases. Reporting to the VP, Biometrics, the Head of Clinical Data Management will serve as a strategic and operational leader responsible for overseeing all aspects of Clinical Data Management across the development portfolio, from early development through regulatory submissions and post-marketing activities.

This role is accountable for the strategy, quality, consistency, and delivery of all data management activities, while advancing modern data capabilities, operational excellence, technology innovation, and scalable processes to support efficient and high-quality drug development.

The ideal candidate combines deep operational expertise in clinical data management with a forward-looking mindset in technology, automation, data integration, and innovation. This role partners closely with Biometrics, cross-functional stakeholders, and external partners to ensure timely, high-quality, inspection-ready clinical data across the portfolio.

What You'll Do:

In this role, you'll have the opportunity to define and execute the strategy for Clinical Data Management support across studies, programs, and evidence generation activities, in close collaboration with Biometrics leadership and key cross-functional stakeholders. You'll also:

• 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.

Who You Are:

You must have a Master's degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a related discipline and 12+ years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry. Additionally, you have:

• 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.

Nice to have (but not required):

• Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs is preferred.

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This position involves occasional domestic and/or international travel (approximately 10%).

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Pay Range:
$255,000.00-347,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.