Organizational Overview:
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. The Company’s investigational product, batoclimab, is a fully human, monoclonal antibody that targets and binds to the neonatal Fc receptor (FcRn).
The Role:
The Director, Data Management will be a key role in a dynamic cross-functional development team. Responsible for owning data management across a range of indications. Serves as a key member of the Clinical Leadership Team, contributing to the establishment of an effective, well-functioning organization. Oversees management of all clinical trial data across multiple programs and indications. Interfaces with CROs and is responsible for building and managing the internal Data Management team.
Key Responsibilities:
- Serves as a key member of the Clinical Leadership Team, contributing to the establishment of an effective, well-functioning organization
- Oversees management of all clinical trial data across multiple programs and indications.
- Interface with CROs to ensure that all clinical trial data are collected, managed, and reported clearly, accurately, and securely based on study protocol and requirements, including eCRF designs to study database locks
- Responsible for the implementation of clinical study database, startup documents, reports, and external data/system planning and incorporation/integration
- Ensure that databases are validated and ready for transfer and analysis
- Track data management performance across all programs and indications and share project tracking with development team
- Build and manage internal Data Management Team
- Establish and ensure compliance with Data Management SOPs
Requirements:
- 10+ years of Clinical data management experience in biotech, and/or pharmaceutical industry
- Advanced degree (PhD, MS, etc.) preferred
- Previous biologics and/or immunotherapy experience a plus
- Strong understanding of laws and policies governing the pharmaceutical industry as they relate to data management, including CRF, GCP, and ICH guidelines
- Mastery of clinical databases, data management systems, and electronic data capture (EDC)
- Excellent analytical, organizational, and project management skills, with strong attention to detail
- Consistently able to produce quick, thorough, and accurate work
- Entrepreneurial spirit, willing to go above and beyond to manage multiple projects simultaneously and achieve key objectives in a fast-paced and fluid startup environment
- Natural collaborator who enjoys working on a cross-functional team
Work Environment:
- Remote-based; Immunovant’s headquarters is in NYC
- Dynamic, interactive, fast-paced and entrepreneurial environment
- May require up to 20% travel
We are driven by our vision of enabling normal lives for people with autoimmune diseases, and we embrace #allvoices by bringing a diverse and talented group of people together. We are committed to inclusion & equity across race, ethnicity, gender, age, religion, physical ability, identity, sexual orientation, and experience. We are an equal opportunity employer, and we welcome you to join us on this journey as your whole, authentic self.
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $161,694 - $245,733.