Organizational Overview:
Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.
The Role:
The Director, Project Management, CMC will report to the Head of CMC Process Development & Technical Operations and will be responsible for providing project management within the CMC organization to help drive success of the monoclonal antibody development programs. The Director will work collaboratively with the various functional areas within process and device development, analytical development, packing labeling, distribution, and regulatory and clinical operations to ensure smooth and efficient operational implementation of functional goals. This individual will also provide oversight of CMOs and must understand process development and optimization, technology transfer, clinical manufacturing, supply management, validation, and QbD principles. In cooperation with finance, the Director will help develop and monitor the budget and deliver the company’s development programs on schedule. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident project manager with a proven track record in managing and driving project success monoclonal antibody projects within CMC in the biotech and/or pharma industry.
Key Responsibilities:
- Work closely with functional areas to develop and maintain project plans that drive organizational objectives, including all CMC activities (upstream, downstream, formulation, analytical, device, packaging, labeling, and distribution)
- Assist with the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work
- Understand, communicate, and drive CMC team to meet the deliverables, goals, and challenges appropriately
- Partner with functional areas to develop appropriate resource and prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges
- Facilitate and project manage external development at contract research organizations
- Monitors risks in real time to ensure appropriate mitigation plans are put in place
- Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals
- Effectively manage multiple projects and responsibilities concurrently
- Track deliverables from team members and support associated action item management
- Consistently perform duties within established SOPs and in accordance with GxP requirements.
Work Environment:
- The position will be located in Immunovant’s NY office
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel required (10-20%)