The Clinical Research Associate is responsible for monitoring clinical studies at investigative sites or remotely to ensure compliance with protocols, SOPs, and regulatory requirements. They will perform source documentation verification, review patient data, and provide support to site staff to ensure accurate reporting.
The Director/Head of Pharmacovigilance will lead the safety function, providing operational oversight and guidance to a dedicated team. They are responsible for managing risk mitigation activities, ensuring regulatory compliance, and representing product safety in cross-functional environments.
The Medical Science Liaison will foster relationships with key opinion leaders and support the scientific strategy for next-generation cell therapies. They will serve as a subject matter expert, providing clinical insights and managing scientific exchanges within the designated territory.
The Director of Case Management will lead the daily operations of the national case management function, ensuring efficient and empathetic coordination for TREGZI therapy. They will also collaborate with leadership to scale the customer service model, refine workflows, and manage team performance.
The associate is responsible for reviewing adverse events, determining regulatory reporting requirements, and managing safety database entries. They also serve as a liaison between internal teams and external vendors to ensure accurate and timely safety reporting.
The Senior Specialist will implement and maintain the global Quality Management System across all sites, including managing internal audits and supplier programs. They will also lead inspection readiness activities and collaborate with cross-functional teams to ensure compliance with GxP and regulatory standards.
The Medical Science Liaison will foster relationships with key opinion leaders and support the scientific strategy for next-generation cell therapies. They will also serve as a subject matter expert, providing clinical insights and supporting investigator-sponsored trials within their designated territory.
The Medical Science Liaison will foster relationships with key opinion leaders and support the scientific strategy for next-generation cell therapies. They will also serve as a subject matter expert, providing clinical insights and supporting investigator-sponsored trials within their designated territory.
The VP of Medical Affairs will build and lead the Medical Affairs function, overseeing MSLs, medical communications, and investigator-sponsored trials for Orca-T. This role involves establishing relationships with key opinion leaders and collaborating with R&D and Commercial teams to support product launch and data promulgation.
