The Head of Pharmacovigilance will lead safety strategy, science, and operations while building an inspection-ready PV function for a growing clinical-stage portfolio. This role involves managing outsourced vendors, ensuring global regulatory compliance, and partnering with cross-functional teams to support clinical development.
The Vice President of Medical Affairs will define and execute the medical strategy across the company's pipeline, with an initial focus on JADE101 in IgA nephropathy. They will serve as a scientific partner to internal teams and lead external engagement with key opinion leaders and patient advocacy groups.
The Director of Clinical Operations will lead cross-functional study execution teams and oversee the strategic and operational execution of clinical trials. They are responsible for managing trial budgets, selecting vendors, and ensuring compliance with regulatory standards throughout the drug development process.
The Medical Director will lead the design, execution, and oversight of clinical trials in nephrology while serving as the medical monitor to ensure patient safety. They will also collaborate with cross-functional teams and regulatory bodies to advance the company's clinical pipeline.
The Senior Clinical Scientist will lead the execution of Phase 2 and 3 clinical trials in nephrology, focusing on protocol development and scientific oversight. They will manage data review, medical monitoring, and collaborate cross-functionally to ensure regulatory compliance and data quality.
The role manages the end-to-end document lifecycle and training processes, including creation, review, and archival of controlled documentation. It also involves establishing training matrices and ensuring audit-ready traceability for pharmaceutical R&D functions.
