Description The 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 Responsibilities- Develop 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.
Requirements - 10+ years of IT leadership experience within the pharmaceutical, biotechnology, or broader life sciences industry; experience supporting Phase 3 clinical development and/or commercial launch strongly preferred.
- Experience in a public company environment with IT controls, compliance, and audit requirements.
- 5+ years of management experience leading small internal teams and extended vendor/managed-service ecosystems.
- Strong knowledge of enterprise IT architecture, infrastructure, cybersecurity, applications, and operations.
- Required knowledge and hands-on experience with GxP validation and regulatory requirements, including 21 CFR Part 11, GAMP 5, Annex 11, and SOX.
- Hands-on experience authoring and executing validation plans, risk assessments, IQ/OQ/PQ protocols, traceability documentation, and validation summary reports.
- Experience with Windows Server, Microsoft Azure, and Active Directory.
- Experience with life sciences and enterprise platforms such as Veeva Vault, NetSuite or comparable ERP, eQMS, CTMS, or safety systems preferred.
- Demonstrated success partnering with executive leadership to align IT strategy, budgets, roadmaps, and investments with corporate objectives, including presenting to executive, audit, and Board-level audiences.
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