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.
The Associate Director of Clinical Quality Assurance will lead quality oversight for clinical programs, including designing risk-based strategies and conducting audits of sites and vendors. They will also drive inspection readiness, manage compliance investigations, and collaborate with internal teams to ensure adherence to regulatory standards.
The Associate Director will lead and scale the clinical data management function, overseeing end-to-end data activities across clinical studies. They will serve as a subject matter expert, driving data quality, technology implementation, and cross-functional collaboration with clinical operations and regulatory teams.
Build and scale the regulatory operations function, overseeing end-to-end submission planning and delivery for global regulatory applications. Serve as the enterprise owner of the regulatory information management platform and lead cross-functional teams to ensure zero-defect filings.
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.
