Organizational Overview:

 

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

 

The Role: 

 

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.

Key Responsibilities: 

 

Leadership

  • 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

 

IT Validation

  • 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

 

Requirements:

 

  • 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

 

Work Environment:

 

  • 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%