Immunovant

QA Engineer

• Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase-appropriate, fit-for-purpose Audit Program
• Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments.
• Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
• Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study
• Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
• Oversee the implementation of appropriate and timely Deviation, Investigations and
• Participate in risk review meetings and review study Risk Management
• Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator’s Brochure, for ensuring quality, accuracy, and completeness
• Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls
• Identify process improvements to build compliance into the design and conduct of clinical activities
• Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors

Director, Clinical Quality Assurance – CQA

Operations

• Lead the TMF operating model, including strategy, governance, standards, and operating model to support portfolio
• Define and implement TMF processes, standards, and KPIs to promote consistency, quality, and compliance across studies and vendors utilizing a risk-based approach to ensure sponsor oversight
• Oversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations
• Lead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadership
• Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies
• Serve as the TMF subject matter expert, guiding cross-functional teams, influencing best practices, supporting role-based training for sponsor and CRO teams, and monitoring adoption and uptake through metrics and governance
• Lead and support TMF-related activities for health authority inspections (FDA, EMA, and other regulatory agencies)
• Drive continuous inspection readiness by defining, implementing and improving the TMF/eTMF operating model and performance program
• Serve as TMF lead/SME for TMF-related inspections and QA audit activities
• Drive TMF inspection preparation, SME briefing, document retrieval, and response coordination including TMF demonstrations, evidence packages and remediation planning
• Lead or support remediation and CAPA development for TMF-related inspection findings
• Drive eTMF system strategy and governance, including:
• System configuration, taxonomy, and metadata standards
• Lead cross system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory and QMS to support trial reconstruction
• Vendor/system performance and optimization
• Partner with CBO Ops, IT and quality systems on validation and change control for eTMF and related systems, as applicable
• Oversight of enhancements, releases, and UAT
• Drive TMF quality at scale by:
• Establishing QC/QR frameworks and oversight models
• Driving effective TMF reconciliation practices across functions and vendors
• Identifying systemic gaps and implementing continuous improvement initiatives
• Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building
• Partner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to drive end-to-end TMF alignment
• Lead and support TMF-related risk management, including proactive identification and mitigation of compliance risks
• Lead or support TMF migrations, system implementations, and vendor transitions
• Partner with Procurement/Legal and Alliance Management to embed TMF expectations in contracts and SOWs (access, reporting, audit rights, inspection support)

Director, TMF Operations

Medical Director

• Provide clinical scientific leadership for the clinical study team.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide medical safety oversight of CRO medical monitors.
• Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
• Collaborate closely with partners in Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Lead the design and writing of clinical protocols and associated clinical documents.
• Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
• Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
• Assume primary responsibility for presentations related to clinical trial data and assist in the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
• Contribute to the writing of manuscripts and publications.
• Comply with Immunovant's SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, IMVT BOD meetings, etc.
• Develop and maintain strong, collaborative relationships with the broader Immunovant organization.
• Represent Immunovant externally and build successful relationships with multiple stakeholders including trial site Investigators, KOLs, and others.
• Excellence in verbal and written communication, teamwork, and collaboration is a must.

Executive Medical Director – Clinical Development

Director

• Facilitate scientific exchange between industry and the scientific community to help shape the future of healthcare, providing needed information that addresses important clinical and scientific questions.
• As a core responsibility, establish themselves as a reliable and trusted resource of unbiased, accurate, up-to-date medical and scientific knowledge requested by their KOLs.
• Connect KOLs and represent their voice to internal business partners as appropriate and identify possible research or external collaborations.
• Demonstrate strategic analysis, planning, and prioritization to maximize efficiency and adhere to all Immunovant and field medical affairs policies and procedures.
• Enhance professional expertise through attendance of select scientific meetings and professional conferences for the purpose of scientific exchange with key opinion leaders, gathering competitive intelligence, generating clinical trial awareness, and maintaining clinical and scientific expertise.
• Expertise in geography management to coordinate KOL engagements and development, and Immunovant clinical trial support through a KOL engagement plan.
• Interact with investigator sites and other parties to support clinical trial execution. The MSL provides regional and country-specific insights and site feedback to support site identification, patient recruitment, and retention initiatives. In close collaboration with the study team, and the SRMs, the MSL acts as a medical resource for sites to facilitate resolution of issues related to requests for clinical trial and scientific information, attends and may present at Investigator meetings, and may monitor workshops/training.
• Actively contribute and engage with internal Medical Affairs colleagues in team meetings and presentations, share competitive intelligence updates, assist with the training of new MSLs, and share feedback on new educational materials/training.
• Compliantly collaborate with internal stakeholders, including but not limited to MSL field partners, site relationship managers, clinical operations, and commercial teams.

Director, Clinical Quality Assurance – CQA

Director, TMF Operations

Executive Medical Director – Clinical Development

Director, Medical Science Liaison – MSL