Head of Clinical Data Management

Insmed Incorporated•NJ Corporate Headquarters, NJ

2d•$255,000 - $347,500•Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.
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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back