At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
Our Information Technology (IT) department is responsible for establishing, monitoring and maintaining information technology systems and services. IT directs the activities of our Managed Service Partner and oversees the configuration and distribution of laptops and access to relevant files, folders and shared networks. This position will develop and maintain an overall IT Strategic Plan and Roadmap, as well as plan, lead and implement the tactics to deliver company-wide standards and practices relative to hardware, software and cyber security.
This position will also be responsible for the IT component of the Company’s NetSuite ERP implementation and ongoing support.
Accountabilities and Responsibilities
- Develop and maintain an overall IT Strategic Plan and Roadmap.
- Direct the activities of the Neurogene Managed Service Provider, including help desk, network management, system backup and recovery, computer provisioning and configuration, computer asset management; provide limited desktop support as is needed to ensure day-to-day IT concerns are appropriately handled.
- Develop company-wide IT standards in consultation with best practices for Hardware, Software and Security.
- Develop and manage the IT expense and capital budgets.
- Oversee IT operations in Houston manufacturing; local Houston IT will have a direct line into this position with a dotted line into Houston management; review IT proposals; ensure that Houston adheres to corporate IT standards; oversee computer systems validation for manufacturing operation systems
- Develop and implement broad company-wide cybersecurity initiatives: end point management (virus, malware, phishing, etc.); Data integrity and encryption (at rest and in transit); Implement Mobile Device Management (MDM) solution across the organization; Implement multi-factor authentication solution, Implement MS Active Directory policies (password rules and expirations, user admin access, MS updates), Conduct periodic cybersecurity awareness training across Neurogene organization, Develop onboarding/offboarding procedures with HR, Conduct periodic reviews/audits of user access and permissions for IT systems and applications.
- Develop and maintain IT Policies and Standards in partnership with key stakeholders.
- Develop and implement a formal Disaster Recovery/Business Continuity plan for Neurogene; complete annual testing.
- Support the implementation of and go-live of the NetSuite ERP system. Ensure departmental IT initiatives. Ensure conformance to company IT technology and security standards. Meet regularly with department/functional leaders to understand IT needs and issues, including ERP, Document Management (Veeva or similar), Financial reporting systems (outside of ERP, e.g., FP&A), Regulatory and Legal (Submissions, Contract Management), Clinical, HR Systems (if not included in ERP).
- Provide IT System Project Management as needed.
- Implement IT controls for conformance to SOX/SSAE financial audit standards. Assist with routine internal and external IT audit reviews.
- Implement IT policies and procedures to ensure compliance with GxP and CFR Part 11 regulations; oversee the planning, implementation, and management of all computer system validation activities (e.g., Veeva, ERP, Manufacturing, Clinical, Regulatory).
- Implement regular employee training for IT skills.
- Review all contracts and agreements for IT systems and services. Manage ongoing software and services licenses (Microsoft, Veeva, ERP, etc.).
- Provide periodic IT status updates to senior management.
- Bachelor’s Degree required
- Master’s degree preferred
- Minimum 8 years in information technology
- Experience in the pharmaceutical, medical device, or biotech industry is preferred
- Licenses or Certifications
- FDA computer system validation and CFR part II, preferred
- Knowledge & Skills
- Life science and biotech industry knowledge
- Deep IT systems, network, shared drive, privacy and cyber security expertise
- Ability to work independently and in collaboration cross-functionally and complete tasks efficiently
- ERP implementation experience required – NetSuite preferred
- Deliver IT solutions as a business partner
- Ability to manage multiple priorities in a fast-paced environment; ability to embrace change
- Strong investigative, analytical and problem-solving skills
- Coach to ensure awareness and compliance with IT policies, practices and processes
- Process development, documentation and continuous improvement skills
- Ability to understand and communicate information to internal and external stakeholders and tailor information to specific audience
- Superior written and oral communication skills
- Rigorous work ethic with a focus on detail and high-quality results, ability to anticipate and meet IT needs, strong interpersonal skills
- Excellent organizational skills and ability to work in a matrixed organization