Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Director of Research & Development (R&D) and Quality Systems to function as a core member of the IT function and act as the IT leader for the R&D and Quality functions. In this role, you will develop capabilities and secure resources to support the delivery of the strategic agenda. The successful candidate will have previously built or managed R&D and Quality systems roadmap, with a Veeva core, demonstrating an exceptional aptitude for delivering on initiatives. Excellent communication style and proven success balancing project management, business analysis and technology strategy/implementation are required. Equally critical to success is the ability to build relationships across the R&D & Quality functions and seek ways to support their objectives while pursuing the corporate needs for process standardization, security, innovation, and efficiency.
- Lead and own R&D and Quality business architecture by articulating business strategy and maintain currency of the IT roadmap for the R&D and Quality functions
- Act as a solutions champion and provide strategies for the education and development of systems for the R&D and Quality community
- Provide technical leadership and guidance to the R&D and Quality functions
- Form and lead R&D and Quality governance forums for alignment and effective and transparent decision-making process
Project Delivery and Execution
- Lead end-to-end service delivery to the R&D and Quality teams--including requirements gathering, functional design, systems and user documentation, testing, training and support operations.
- Ensure compliance with project timelines and response to information requests for R&D and Quality functions
- Develop and implement policies, controls, and processes in compliance with regulatory requirements.
- Ensure oversight of R&D and Quality systems land scape
- Lead and direct IT validation workstreams for all GxP systems initiatives
- Maintain currency of IT Computer Systems Validation (CSV) SOPs pertaining to the implementation and operation of all GxP systems
- Ensure compliance with IT CSV SOPs for all GxP systems
- 10 to 15 years of experience at a life sciences, biotech, or pharmaceutical company providing project management and business systems analysis services in a fast-paced, demanding environment
- Strong background in Veeva deployment (QDocs, QMS, RIM)
- Thorough understanding of system validation and change management
- Strong understanding of 21 CFR Part 11 and Eudralex Annex 11 regulations
- Expertise in project management methodologies e.g. PMP, PRINCE2 and/ or operational excellence tools e.g. Six Sigma
- Experience with change management methodologies and business process re-engineering
- BA/BS in Information Technology, business, or science
- MBA or advanced degree with specialization in operations strategy or quality operations strongly preferred
- Project Management or Six Sigma or other process certifications strongly preferred
- Certifications in Veeva platform preferred
- Multitasking ability to oversee several projects and reach milestones on time
- Strong written and oral communication skills with incredible attention to detail
- Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Natural collaborator who enjoys working on a cross-functional team
- Preferred location is Immunovant’s NYC office; Durham office or remote considered
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required 15%