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.
Serve as the primary liaison between Orca Bio and Authorized Treatment Centers to manage relationships and ensure site readiness. Drive the appropriate use of cell therapies by coordinating logistics, educating personnel, and analyzing account performance.
Oversee the quality component of the onboarding process for commercial Authorized Treatment Centers on the West Coast. This includes conducting site assessments, managing timelines, and coordinating with internal teams to ensure compliance with quality standards.
Lead the commercial legal function to support the first U.S. product launch, providing strategic advice to Sales, Marketing, and Medical Affairs. Act as the subject matter expert on U.S. healthcare laws and oversee the company's risk-based compliance program.
Serve as the primary liaison between Orca Bio and Authorized Treatment Centers to manage relationships and ensure site readiness. Drive the appropriate use of approved therapies by coordinating logistics and educating healthcare stakeholders.
The Lead Clinical Data Manager oversees all aspects of clinical trial data management from study start-up through database lock. This includes designing CRFs, managing EDC builds, ensuring CDISC compliance, and coordinating data cleaning and reconciliation.
