IT Strategy and Portfolio Management:
- Develop, implement, and continuously refine a comprehensive IT strategy in partnership with the Head of IT and functional stakeholders that aligns with and supports overall business objectives.
- Drive innovation by integrating emerging technologies and leading digital transformation initiatives that align with the strategic vision of Kura Oncology.
- Establish and maintain a robust IT portfolio management framework, including tools and processes for project prioritization, resource allocation, and performance tracking.
- Conduct regular portfolio reviews to ensure optimal balance of risk, value, and strategic alignment.
- Collaborate with business units and system owners to identify and prioritize IT initiatives that drive business value.
- Implement and maintain security policies based on roadmap initiatives and business goals of the company.
- Evaluate system vulnerabilities and conduct regular audits, risk assessments, and compliance checks to ensure security standards are met.
- Coordinate with the Incident response team in responding to any security incidents and investigating root causes, while implementing corrective measures to prevent future occurrences.
AI Strategy, Governance, and Enablement:
- Partner with the Head of IT and business leaders to develop and execute the company’s enterprise AI strategy and roadmap, identifying opportunities to leverage artificial intelligence, generative AI, and automation to improve productivity, decision making, and business outcomes.
- Establish and maintain an AI governance framework addressing appropriate use, data privacy, information security, regulatory compliance, intellectual property, risk management, and responsible AI practices.
- Lead the evaluation, selection, and implementation of enterprise AI platforms, tools, and capabilities, ensuring alignment with the company’s technology architecture, security requirements, and business objectives.
- Partner with functional stakeholders to identify, prioritize, and develop high value AI use cases across the organization, establishing clear business outcomes, ownership, success criteria, and measures of value.
- Collaborate with Information Security, Legal, Compliance, Quality, and business stakeholders to assess and manage risks associated with AI technologies, including sensitive and confidential data, model outputs, third party services, and regulatory requirements.
- Develop policies, standards, and procedures governing the responsible use of generative AI and other AI technologies across the organization.
- Drive responsible adoption of AI through employee education, training, communications, and change management programs that improve AI literacy and encourage effective and appropriate use of approved AI tools.
- Ensure AI solutions supporting GxP or other regulated business processes are appropriately assessed, documented, validated, and governed in partnership with Quality and applicable Business System Owners.
Change Management and Communications:
- Develop and execute comprehensive change management strategies for major IT initiatives and organizational transformations.
- Create and maintain a change management framework and train IT Team on effective use to deliver change in a consistent manner.
- Lead the development and execution of multi-channel IT communication plans, ensuring clear and effective messaging to all stakeholders.
- Establish feedback mechanisms to measure the effectiveness of change initiatives and communications.
- Collaborate with HR and other departments to align IT changes with broader organizational change efforts.
Compliance & Validation Management:
- Ensure IT systems used in GxP-regulated processes and implemented, validated, and maintained according to regulatory standards and Kura business processes.
- Collaborate with Business Systems Owners, IT, and Quality teams to develop and execute validation deliverables (IQ/OQ/PQ).
- Monitor system changes to ensure compliance with change control procedures and regulatory standards
GxP System Audits and Inspections:
- Support internal and external audits, including those conducted by regulatory authorities (e.g., FDA, EMA).
- Prepare compliance documentation and provide necessary evidence for GxP audits and inspections.
- Follow up on audit findings and assist with remediation plans to close gaps
IT Operating Model and Governance:
- Continuously assess and refine the IT operating model to enhance efficiency, effectiveness, and alignment with business needs.
- Establish and maintain IT governance frameworks, including decision-making processes to support cross functional steering committees and drive efficiencies across IT.
- Develop and oversee IT performance metrics and scorecards to drive continuous improvement.
Budget and Forecasting:
- Working with Head of IT to oversee the development and management of the annual IT budget, ensuring alignment with strategic priorities and maximizing ROI on IT investments.
- Implement robust financial management processes that can be quickly adopted/adapted to by the IT Team.
- Develop accurate IT financial forecasts, considering technology trends and business growth projections.
On-site
