Director, TMF Operations

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Immunovant

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2018

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant ist ein Unternehmen, das sich darauf konzentriert, Behandlungen für Autoimmunerkrankungen mit einem patientenzentrierten Ansatz voranzutreiben. Mit der Vision, Menschen mit Autoimmunerkrankungen ein normales Leben zu ermöglichen, nutzt Immunovant seine Expertise in der Wissenschaft, um neue Therapien zu entwickeln und zu testen. Das Unternehmen legt Wert auf die komplexen und variablen Bedürfnisse in verschiedenen Stadien und Schweregraden von Krankheiten. Immunovant engagiert sich dafür, seine therapeutischen Bereiche und klinischen Studien voranzutreiben, während es gleichzeitig den Austausch mit Patienten, Pflegekräften und Investoren über laufende Studien und Unternehmensinitiativen fördert.

Beschreibung

• 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)

🎯 Anforderungen

• BS/BA degree required, advanced degree highly desirable • 8–12+ years of clinical research experience, including significant TMF/eTMF leadership experience • Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model • Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA) • Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements • Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent) • Experience managing CROs/vendors and holding them accountable for TMF quality and delivery • Excellent communication and ability to represent TMF in regulatory-facing settings • 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. • Demonstrated ability to lead cross-functional initiatives and influence at a senior level • Strong leadership, strategic thinking, and decision-making skills

🏖️ Vorteile

• Medical, dental, and vision insurance • 401(k) plan • Unlimited paid time off • Parental leave