Senior Director, Information Technology (BioPharma)

Description

The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and application roadmaps for a late-stage clinical biopharmaceutical company transitioning to commercialization. This hands-on leader will scale capabilities, establish governance, manage a small internal team alongside MSPs/consultants, and align IT with corporate goals while partnering with executive leadership, auditors, and regulatory stakeholders.

Key Qualifications

• Commercial Launch Experience: Must have led an IT organization through a BioPharma commercial launch (e.g., Phase 3 through launch/commercialization).

• Compliance & Technical Depth: Deep, hands-on experience in GxP (21 CFR Part 11, GAMP 5) and SOX environments. Comfortable executing work directly, not just delegating.

• Cybersecurity & Risk: Proven success overseeing cybersecurity programs, threat management, compliance, and risk frameworks.

• Strategic Business Partnering: Strong track record collaborating with executive and cross-functional leadership to translate business needs into technology solutions.

Key Responsibilities

• Strategy & Leadership: Develop and execute the IT roadmap, strategy, and budget. Present risk, progress, and investments to executive leadership and Audit/Board committees. Build lightweight project intake and prioritization governance.

• GxP & Quality Validation: Own the Computer System Validation (CSV) program, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and change control in accordance with 21 CFR Part 11 and GAMP 5. Maintain audit readiness and data integrity.

• SOX Compliance: Manage IT General Controls (ITGCs) covering logical access, change management, and operations. Coordinate auditor walkthroughs, evidence collection, and remediation.

• Cybersecurity & Operations: Direct managed security service providers (MSSPs) on incident response, vulnerability management, penetration testing, endpoint protection, and DLP. Develop IT policies to protect corporate IP.

• Infrastructure & Helpdesk: Oversee infrastructure, Windows/Azure environments, and IT helpdesk vendors, providing hands-on escalation support when needed.

• AI & Innovation: Partner with leadership to identify high-value AI/automation opportunities (e.g., M365 Copilot, ERP/validated system AI capabilities). Evolve AI acceptable-use policies, vendor due diligence, and CSV impact assessments.

• Vendor & Team Management: Lead a small internal team while optimizing an ecosystem of MSPs, validation partners, and software vendors. Negotiate IT outsourcing agreements.

Requirements

• Experience: 10+ years of IT leadership in biotech/pharma, explicitly supporting Phase 3 development through commercial launch. 5+ years directly managing internal teams and external vendor networks.

• Regulatory Expertise: Demonstrated hands-on experience authoring and executing GxP validation deliverables (21 CFR Part 11, GAMP 5, Annex 11) and managing public company SOX ITGCs.

• Technical Proficiency: Strong background in Microsoft Azure, Windows Server, Active Directory, and cybersecurity frameworks.

• Systems Exposure: Experience with life sciences and enterprise platforms (e.g., Veeva Vault, NetSuite or comparable ERP, eQMS, CTMS, safety databases) preferred.

• Education: Bachelor’s degree in Computer Science, IT, or related life science field preferred.

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