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 QualificationsCommercial 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 ResponsibilitiesStrategy & 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.