Role Summary
The Executive Director, Cybersecurity & Risk Management will oversee cybersecurity operations, enterprise risk management, and the Computer Systems Validation (CSV) program. This role manages cross-functional teams and ensures regulatory compliance while maintaining operational excellence. Reporting to the Chief Information Officer, this position defines and executes Insmed’s enterprise cybersecurity and risk strategy. It requires a strategic, hands-on leader who can think globally, act decisively, and communicate complex risks in business terms to foster trust and resilience across the organization.
Responsibilities
- Strategic Leadership
- Define, communicate, and execute Insmed’s cybersecurity and risk management vision, aligning with values, priorities, and regulatory commitments.
- Present cybersecurity posture, threats, and key initiatives to the CIO, IT Leadership Team, Executive Committee, and Board as needed.
- Establish governance frameworks and control structures aligned with NIST and FDA data protection standards.
- Collaborate with Legal, Compliance, Clinical Operations, Quality, and R&D to proactively manage risk across the technology landscape and protect sensitive data.
- Demonstrated experience leading a Computer Systems Validation team in a regulated environment is a plus.
- Foster a culture of security accountability and awareness across the organization.
- Hands-On Technical Leadership
- Lead and participate in cybersecurity operations including incident response, threat detection, vulnerability management, and risk remediation.
- Architect and operationalize security solutions across cloud, data, and endpoints using zero-trust principles.
- Act as a senior escalation point for major incidents, directing containment, recovery, and post-event reviews.
- Guide adoption of AI-driven threat analytics, secure DevOps practices, and automated response frameworks.
- Oversee penetration testing, red teaming, and risk assessments with actionable follow-up.
- Stay engaged with emerging technologies and regulatory developments in healthcare cybersecurity.
- Deep understanding of GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 is a plus; experience with CSV validation lifecycle is favorable.
- Collaborate with Quality, IT, and business stakeholders to ensure systems are validated and compliant throughout their lifecycle.
- Familiarity with documentation validation, audit readiness, and continuous improvement of CSV processes.
- Risk Management
- Define and implement risk management policies and frameworks aligned with organizational objectives.
- Conduct enterprise-level risk assessments and develop mitigation strategies.
- CSV Program Oversight
- Oversee the CSV team, validation strategy, and continuous process improvement.
- Ensure compliance with GxP regulations and industry standards.
- Familiarity with validation documentation, audit readiness, and continuous improvement of CSV processes is a plus.
- Team & Organizational Leadership
- Build, mentor, and inspire a high-performing cybersecurity organization with a focus on continuous learning.
- Lead through influence, collaborating with IT, R&D, Quality, and Business Operations to embed security across initiatives.
- Manage key vendor and service-provider partnerships to ensure performance and alignment with security objectives.
- Drive operational excellence balancing strategic priorities with hands-on execution and measurable results.
Qualifications
- Minimum 15 years of progressive IT and cybersecurity experience, with at least 10 years in senior leadership roles managing enterprise-level programs.
- Hands-on experience in cybersecurity operations, engineering, or architecture.
- Proven ability to communicate with and present to Executive Management and Boards of Directors.
- Strong understanding of risk management, compliance, and audit processes within regulated industries, ideally biotechnology or pharmaceuticals.
- Bachelor’s degree in Computer Science, Information Systems, Cybersecurity, or related discipline (advanced degree preferred).
- Professional certifications such as CISSP, CISM, GIAC Security Leadership, CCSP; OSCP or other technical certifications a plus.
Education
- Bachelor’s degree in Computer Science, Information Systems, Cybersecurity, or related discipline (advanced degree preferred).
Knowledge, Skills & Attributes
- Mission-driven mindset—understands that protecting systems and data protects patients.
- Strong executive presence and communication skills; can articulate complex cybersecurity risks to non-technical audiences.
- Deep technical proficiency across cybersecurity frameworks, cloud security, and identity management.
- Budget planning, vendor management, and strategic program delivery capabilities.
- Proven track record of driving change, innovation, and process excellence in regulated environments.
- Collaborative, influential, and empathetic leader who thrives in cross-functional partnerships.
- Continuous learner, staying ahead of emerging threats, technologies, and industry standards.
Additional Requirements
- This position may occasionally require evening or weekend work to support critical incidents, deployments, or maintenance activities.
- Hybrid or remote flexibility may be considered based on business needs.