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.
Reporting to the VP of Clinical Operations, the Director, TMF Operations is responsible for providing strategic, planning, oversight and delivery of the clinical documentation function throughout the lifecycle of clinical development programs. This role will work collaboratively and strategically with VP of Clinical Operations and our cross-functional teams and external partners to establish standards for TMF-related activities including: implementation of a global eTMF system including TMF related SOPs, processes and best practices; development of metrics and tracking of eTMF performance to ensure and promote a continuous state of audit readiness, and compliance with regulatory requirements and the principles and standards of GCP, as well as GDPR standards.
- Define and build Immunovant’s eTMF program including cross-functional resource needs, quality/system technical requirements, accountable for eTMF system alignment across functions
- Establish company-wide standards for TMF-related activities including document quality standards; lead efforts to drive adoption of innovations related to TMF performance management to optimize risk-based quality management and enhance analytic capabilities enabling a proactive approach to ensure compliance with regulatory requirements
- Manage TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained in accordance with ICH guidelines and global regulatory requirements
- Provide technical oversight and liaise with cross-functional partners to support ongoing TMF system maintenance and enhancements in accordance with system-related regulations and guidance documents
- Provide SME and liaise with cross-functional partners to define and manage document structure, repositories, inventory, and access for on-site clinical documentation storage in accordance with procedures and global standards
- Oversight accountability to ensure all clinical documentation is being collected, handled, transferred, stored via secure and authorized methods, ensuring compliance with GDPR standards and local privacy requirement standards including identification of any systems or processes necessary to fulfill requirements
- Accountable to develop and/or oversee the risk-based TMF oversight strategy and workstream in collaboration with cross-functional team including portfolio-level clinical documentation related risk identification, management, and mitigation efforts and report progress to senior leadership
- Respond to and participate in Quality Assurance audits and/or regulatory authority inspections
- Accountable for overall clinical documentation performance of regulated clinical trials including eTMF inspection readiness; responsible for oversight of regular quality checks including results reporting to senior leadership
- Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools
- B.S./B.A. degree required, advanced degree highly desirable
- 8+ years’ clinical research with progressive management experience in clinical documentation space (minimum 4 years of direct TMF oversight experience)
- Experience in gene therapy, rare/orphan disease and/or late phase trials is highly desirable
- Experience designing, standardizing, and implementing TMF strategies and standards for global development programs is required
- Experience in managing CROs performing TMF activities is required; experience with Veeva Vault is highly desirable
- Experience implementing and overseeing a TMF system is required
- Experience with all aspects of clinical trial conduct (startup through close-out) is required
- Experience overseeing the transition of TMF activities from an outsourced vendor to insource is highly preferred
- Experience in regulatory filings (e.g., NDA, BLA, MAA) is highly desired
- Ability and willingness to travel up to 10% of the time, as needed (domestic)
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Understanding of drug development and program management from pre-IND through regulatory filing is essential
- Demonstrated excellence in complex project management and effective management of multiple projects/priorities
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
- Previous involvement in the oversight and management of GCP regulatory inspections required
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Domestic travel required (up to 10%)