Job Summary:The IT Director will lead the strategic planning, implementation, and management of all information technology systems and infrastructure for a commercial-stage biotech/pharmaceutical company. Reporting to the Chief Administration Officer (CAO), this role plays a critical part in enabling operational excellence across corporate functions, commercialization, regulatory compliance, and scalable growth. The ideal candidate will have broad experience in Life Sciences identifying, implementing and supporting line of business systems for clinical, quality, medical, commercial, finance, regulatory and more along with strong leadership of internal teams and external service providers.
Primary Relationships:- Within Cristcot: This role will interface with executives and SMEs (subject matter experts) across the organization.
- Outside Cristcot: This role will work with outside vendors and partners to scope and implement platforms, technologies and services across the organization.
The activities of the IT Director will include, but are not limited to:IT Strategy & Leadership- Develop and execute the company's IT strategy aligned with business objectives and administrative priorities, including Finance, HR, Legal, and Corporate Operations.
- Serve as a key partner to the CAO in driving enterprise-wide efficiency, governance, and digital enablement.
- Build, lead, and mentor a high-performing internal IT team, fostering a culture of accountability, service excellence, and continuous improvement.
- Define team structure, roles, and development plans to support organizational growth.
- Develop strategy and identify use cases for standalone AI tools (ChatGPT) and AI tools embedded in solutions.
IT Operations & Helpdesk Management- Oversee day-to-day IT operations, ensuring reliable delivery of services across all business functions.
- Establish and monitor KPIs for helpdesk performance (e.g., response times, resolution rates, user satisfaction).
- Ensure seamless escalation processes between outsourced support and internal IT resources.
- Continuously improve end-user support experience and operational efficiency.
Commercial & Launch Support- Lead IT systems readiness for product launch, including CRM (e.g., Salesforce), ERP (e.g. NetSuite), supply chain, and distribution systems.
- Support sales, marketing, and market access teams with compliant, scalable technology solutions.
- Ensure data integration across commercial platforms for analytics and reporting.
Regulatory Compliance & Quality- Ensure all systems meet regulatory requirements (FDA 21 CFR Part 11, EMA, GxP, data integrity standards, ISO).
- Partner with Quality and Regulatory teams to maintain audit/inspection readiness and system validation (CSV/CSA).
- Oversee documentation, SOPs, and system validation lifecycle.
Infrastructure & Cybersecurity- Oversee IT infrastructure, cloud environments, networks, and end-user services.
- Implement and maintain robust cybersecurity frameworks (e.g., NIST, ISO 27001).
- Ensure business continuity, disaster recovery, and risk management processes.
- Develop cybersecurity program maturity roadmap.
Enterprise Systems & Corporate Functions Support- Oversee and optimize enterprise systems supporting Finance (ERP), HR (HRIS), Legal (CLM), and other administrative functions.
- Ensure alignment and integration across corporate, clinical, manufacturing, and commercial systems.
- Drive data governance, reporting, and analytics capabilities to support executive decision-making.
Vendor & Budget Management- Manage relationships with IT vendors, consultants, and managed service providers (MSPs).
- Oversee outsourced partners including helpdesk, infrastructure, and specialized IT services.
- Develop and manage IT budgets in partnership with the CAO, ensuring cost-effective solutions and ROI.
- Negotiate contracts and service level agreements (SLAs).
Skills and Qualifications:- Bachelor's degree in Information Technology, Computer Science, or related field (Master's preferred).
- 10+ years of IT experience, with at least 5 years in a leadership role.
- Experience in biotech, pharmaceutical, or life sciences industry required.
- Proven experience managing internal teams and outsourced IT service providers.
- Experience supporting commercial launches or scaling operations.
- Strong knowledge of GxP systems, validation (CSV/CSA), and regulatory compliance.
- Experience with platforms such as Veeva, NetSuite ERP, Docusign CLM, QMS, and cloud (AWS/Azure).
- Familiarity with API integrations between SaaS systems.
- Familiarity with IT service management frameworks (e.g., ITIL) and helpdesk operations.
- Knowledge of data privacy regulations (HIPAA, GDPR) and cybersecurity best practices.
- Strong strategic thinking and execution capabilities.
- Excellent cross-functional collaboration and communication skills.
- Proven ability to manage vendors and drive accountability with outsourced teams.
- Ability to operate in a fast-paced, high-growth environment.
