The Associate Director will lead the authoring of CMC regulatory submissions and manage global health authority interactions for cell therapy products. They will partner cross-functionally to ensure regulatory strategies align with scientific standards throughout the product lifecycle.
The Sr. Clinical Trial Manager oversees the operational execution of clinical studies from protocol development through database lock. Responsibilities include managing external vendors, coordinating study materials, ensuring regulatory compliance, and providing guidance to clinical research associates.
The Senior Medical Science Liaison will serve as the regional scientific expert, engaging with key opinion leaders and healthcare providers to advance clinical goals. They will also support pre-launch readiness, manage medical congress activities, and facilitate scientific exchange regarding the company's therapeutic pipeline.
Lead risk-based GCP oversight across clinical programs, driving audits, investigations, and inspection readiness to protect patient safety and data integrity. Collaborate with cross-functional study teams to embed quality compliance from first-in-human trials through regulatory approval.
Provide medical oversight and safety monitoring for Phase 2-3 clinical trials to ensure participant safety and data integrity. Collaborate with cross-functional teams and investigators to manage protocol interpretation and regulatory compliance.
Drive the end-to-end strategic planning and execution of scientific publications and congress activities for the AlloNK platform. Translate complex clinical data in rheumatology and immunology into high-impact, compliant scientific communications.
