Jobs at Jade Biosciences, Inc.

Lead pharmacovigilance strategy, safety science, regulatory reporting, vendor oversight, quality systems, inspection readiness, and cross-functional safety activities across a biotechnology portfolio. Build a scalable, inspection-ready PV function; oversee outsourced case processing and safety databases; manage SDEAs, budgets, metrics, audits, and compliance; author and review safety deliverables; and hire and develop PV personnel as the organization advances through global development.

Lead global CMC regulatory strategy and operations for biologics and combination products. Prepare/manage IND/CTA/BLA/MAA and post-approval submissions, support health authority interactions, advise on manufacturing, analytics, specifications, stability, comparability, and lifecycle changes while collaborating with cross-functional and external partners.

Lead strategic and operational execution of clinical trials from FIH to global Phase 3. Manage CRO/vendor selection and budgets, provide technical input to clinical documents, mitigate risk, mentor junior staff, build cross-functional relationships, and contribute to corporate materials and Clinical Operations function development.

Lead GMP Quality Assurance activities for outsourced manufacturing and supply operations across clinical and commercial stages. Oversee CDMOs, review and approve quality records, manage quality agreements, drive risk management, support regulatory submissions and inspections, and coordinate cross-functional QA documentation, batch release, and issue resolution to ensure compliance with cGMP and regulatory requirements.

Lead clinical strategy and execution for Phase 2/3 nephrology trials. Draft and review protocols and study documents, provide medical monitoring and data review, collaborate with operations, biostatistics, regulatory and safety teams, support regulatory submissions, and contribute to scientific communications and investigator interactions.

Manage end-to-end document lifecycle and training programs for biotech R&D. Maintain controlled documentation, training matrices, audit-ready records, version control, and continuous improvement. Support system changes, cross-functional collaboration, and report generation for management reviews.

Lead immunology-driven translational research across pipeline programs. Design and oversee mechanism-of-action studies (in vitro/ex vivo/in vivo) with CROs, generate and interpret complex immunology datasets, prioritize indications and targets, align preclinical findings with clinical strategy, support external collaborations, author regulatory and scientific documents, and present results internally and externally.