Organizational Overview:

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.

The Role:

The Senior Director, Data Management will be a key role in a dynamic cross-functional development team. Responsible for owning data management deliverables across a range of indications. Serves as a key member of the Data Management Leadership Team, contributing to the establishment and maintenance 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 managing internal Data Management team members.

Key Responsibilities:

Serves as a key member of the Data Management 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
Ensure that any subcontracted DM activities are delivered in line with the project expectations (timelines, quality and budget).
Track data management performance across projects and share project tracking with the cross-functional development team and Head of Data Management
Provide line management of internal Data Management team members including recruitment, talent development and performance appraisal and/or manage the functional activities of internal Data Management team members allocated to projects
Support the development and implementation of Data Management SOPs, work instructions, etc. and ensure compliance within line management team.
Support the selection and implementation of new Data Management Innovations such as Data Review tools

Requirements:

15+ 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
Dynamic, interactive, fast-paced, and entrepreneurial environment
Domestic or international travel are required 20%

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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 $275,000.00 to $290,000.00.

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Senior Director, Data Management