NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville focused on discovering and developing first-in-class immunomedicines for the treatment of cancer and other diseases. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development.

Role Summary

We are seeking a highly motivated, and self-starter, Director Information Technology who will be responsible for developing and optimizing strategic and operational capabilities (organization, process, and tools/systems) to support and grow the business. The Director IT will be accountable for providing IT process, application, and project management leadership for new and existing technology solutions. This role serves as an expert in privacy, legal and security needs relevant to the technology area.

As a dynamic, growing company, a successful candidate must be able to adapt and thrive in a fast-paced, innovative, and changing work environment.

Responsibilities

• Focus on capabilities in support of automation (control systems), information technology, site infrastructure and computer system validation used in manufacturing and laboratories operations
• Responsible for business continuity, digital resiliency, and computer systems validation
• Evaluate the system security; create back up and disaster recovery procedures
• Promote information technology innovation and continuous improvement to drive NextCure’s long-term business strategy
• Support, influence, and help to define digital transformation
• Support systems validation and testing for SOX compliance
• Drive annual IT-related business initiative road mapping
• Develop and adopt policies and best practices in line with NextCure’s goals and priorities
• Serve as the primary point person to respond to any security incidents and privacy incidents involving technical applications
• Review technical solutions for privacy and security compliance
• In partnership with the Compliance Committee, ensure risk management priorities are reflected in strategic plans and initiatives
• Execute and manage activities and initiatives aligned with the overall business objectives
• Integrate information from business and technology process, security, and compliance audits and investigations into risk management strategy
• Create IT solutions, business cases, financial impact and benefits statements for new IT solutions
• Work with senior management to define success measures and metrics
• Plan for ongoing resource and capacity requirements
• Ensure software delivery process adheres to regulated SDLC
• Ensure any issues identified in QA or customer audits are properly addressed
• Proactively monitor IT systems to detect intrusions, violations, or other unauthorized access
• Stay current with emerging technical innovations and application development technologies and solutions
• Suggest innovations and technical, process improvements that will lead to operational efficiencies and automation

Requirements

• 10+ years’ experience + Master’s Degree preferred
• Equivalent combination of education, training, and experience in lieu of degree may be considered
• Prior history working for a publicly traded company
• Significant experience in a biotech, specifically in technology and information systems planning to support business goals
• Demonstrated ability to lead the strategic planning and implementation of digital capabilities in a manufacturing site operation
• Knowledge of and experience with SOX regulations and SOX Information Technology General Controls (ITGCs) required
• Computerized Systems Validation (CSV) knowledge
• Ability to communicate, influence and partner with senior business leaders
• Strong knowledge of current good manufacturing/lab processes (GxP), particularly as relates to IT (21 CFR Part 11, Data Integrity, FDA Metrics)
• Demonstrated experience implementing large scale digital capabilities related to laboratories and manufacturing operations including process automation, manufacturing execution and lab systems
• Working knowledge of S88 and S95 standards in relation to process automation and manufacturing execution

Qualifications

• Ability to translate technical terminology into terms understandable to management, customers, and employees
• Expertise in information security concepts including penetration, vulnerability
• Experience in implementing cloud-based applications
• Demonstrate relevant technical, functional and/or process expertise
• Excellent project management and organization skills
• Experience in management of project and IT budgets
• Excellent organizational, communication and problem-solving skills
• Experience with NetSuite preferred

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment.