Senior Director, Information Technology (BioPharma Industry)

Senior Director, Information TechnologyThe Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and the business application roadmap for a growing late-stage clinical biopharmaceutical organization transitioning toward commercialization.This role will architect scalable technology capabilities, establish practical governance, and align IT with business objectives. The leader will manage a small internal IT team, oversee managed service providers and consultants, and partner with executive leadership, functional leaders, auditors, and regulatory stakeholders.Key ResponsibilitiesDevelop and execute the IT strategy, roadmap, budget, and investments in alignment with corporate objectives; communicate strategy, risk, and progress to executive, Board, and Audit Committee audiences.Serve as a strategic IT partner to business leaders, translating operational and regulatory needs into technology solutions and measurable outcomes.Own the Computer System Validation (CSV) program for GxP systems, including validation strategy, risk assessments, IQ/OQ/PQ documentation and execution, periodic reviews, and validated-state change control in accordance with 21 CFR Part 11 and GAMP 5.Own SOX IT General Controls, including logical access, change management, and IT operations; oversee control design, walkthroughs, evidence collection, remediation, and auditor coordination.Maintain audit and inspection readiness for IT systems, records, and data integrity.Establish lightweight IT governance for project intake, prioritization, tracking, and status reporting.Develop business cases and investment plans for infrastructure, security, compliance, and control improvements.Develop project plans and review system specifications, designs, and test results against business requirements.Evaluate and manage technology vendors and service providers, including negotiating IT outsourcing agreements.Lead the cybersecurity program through managed security providers and consultants, covering risk assessments, incident response, forensic analysis, network/application/platform security, penetration testing, vulnerability management, endpoint protection, and data loss prevention.Develop and enforce IT policies, procedures, and operating instructions supporting company SOPs, 21 CFR Part 11, SOX, and protection of intellectual property.Oversee the IT service desk provider, manage escalations, and provide hands-on support when necessary.Lead and develop a small internal IT team while managing an extended ecosystem of service providers, consultants, and validation partners.Partner with leadership to identify high-value AI and automation opportunities and develop an adoption roadmap.Evolve AI governance and acceptable-use policies covering data classification, confidentiality, intellectual property, vendor/model due diligence, human oversight, and documentation.Evaluate and implement AI capabilities within existing platforms, including Microsoft 365 Copilot and AI functionality embedded in validated life sciences and ERP systems, with validation impact assessments as appropriate.Drive responsible AI adoption through training, guardrails, and internal champions while managing security, quality, and regulatory risks.