The Director of CMC Regulatory Affairs will lead global regulatory strategies for biologic and combination products, including the preparation of submissions and briefing documents. They will serve as the primary regulatory lead on cross-functional teams and provide guidance on manufacturing, quality, and lifecycle management.
Jade Biosciences
14 Remote Job Openings at Jade Biosciences
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.
Lead and optimize HR operations, including benefits administration, HR systems management, and employee lifecycle processes. Partner with Finance, IT, and Payroll to ensure compliant and scalable HR services for a growing biotechnology startup.
Lead immunology-driven research strategy and mechanism-of-action studies to support pipeline programs and indication assessments. Collaborate with cross-functional teams to align preclinical findings with clinical strategy and identify new targets for pipeline expansion.
The Director of Clinical Compliance ensures clinical trials adhere to ICH-GCP, regulatory requirements, and internal quality standards. This role leads initiatives in vendor oversight, inspection readiness, and the management of compliance metrics and CAPAs.
The Regional Site Liaison serves as the primary link between the company and clinical trial sites to drive engagement and ensure consistent trial execution. Key duties include managing relationships with Principal Investigators and KOLs, providing protocol support, and communicating field insights to internal teams.
The Regulatory Affairs Manager coordinates and reviews health authority submissions and responses to support the development of biological products. They ensure program activities comply with global regulations and provide regulatory input for clinical study planning.
Provide high-level administrative and operational support to the Chief Legal Officer and other executives. Manage complex calendars, coordinate legal document execution, and handle board and committee materials.
Provides QA oversight for the product pipeline and contract manufacturers (CMOs) to ensure compliance with GMP requirements. Manages quality records, batch release decisions, and collaborates with cross-functional teams to mitigate GMP-related risks.
Associate Director, Clinical Site Budgets & Payments
Jade Biosciences
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Full Time
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5 months ago
Jade Biosciences
This role involves architecting and leading the global strategy for clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across the clinical portfolio. The individual will define global grant philosophy, establish standards for invoicing and budgeting norms, and oversee a full-service CRO partner for operational execution of budgets and payments.
Executive Director, Clinical Quality Assurance
Jade Biosciences
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Full Time
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5 months ago
Jade Biosciences
This role is responsible for all aspects of Quality Assurance focused on GCP, GPvP, and GLP activities to ensure compliance of clinical trials with regulations and guidelines. Key duties include providing hands-on QA oversight, acting as the primary QA subject matter expert, and developing/executing a risk-based audit strategy.
