Lead and manage the day-to-day operational execution of assigned cell therapy trials.
Develop and manage study timelines, budgets, forecasts, and related operational metrics.
Partner with external vendors / CROs / service providers to ensure high quality and timely deliverables.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and are guided by their core values.
Manage site start up through activation readiness strategy and oversight of site start up delivery.
Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations and Contract Execution.
Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals.
Precision for Medicine is a Clinical Research Organization with an integrated offering that enables precision medicine by combining clinical trial designs, experts, biomarker and data analytics solutions. They focus on rare diseases and oncology, in addition to other therapeutic areas.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.