Jade Biosciences

Director

• Select, implement, manage, and oversee GxP electronic systems including any associated Purchase Orders and contracts.
• Develop, implement, manage, continuously improve, and oversee processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes
• Establish and improve policies and standard operating procedures for efficient and compliant management of GxP QMS processes
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes
• Ensure that QMS processes comply with phase applicable regulatory standards, regulations and guidelines.
• Maintain awareness of new regulations, technologies, industry trends and best practices and apply them as may be relevant
• Manage resources to achieve company, department and functional area goals and objectives
• Contribute to the development and maintenance of a positive team-focused company culture
• Provide coaching as a manager and team member, make quality decisions and be Quality Approver as appropriate.
• Act as the primary QMS subject matter expert and point of contact for all related matters and issues.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Champion continuous improvement and simplification across quality systems.
• Contribute to building a strong quality culture within the organization.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, CMC and other departments to drive inspection readiness and support regulatory interactions.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence outcomes.
• Understand when to escalate, when to intervene, and when to let teams move forward.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Senior Executive Director, Quality Management System

Medical Director

• Acts as Clinical Operations program lead for assigned program(s)
• Represents Clinical Operations at the Clinical Development Team and/or Global Program Team
• Develops and executes program operational strategy
• Partners closely and effectively with other functions and functional heads to drive program forward
• Provides strategic and technical recommendations to senior leadership
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)
• Acts as an escalation point for CRO/vendor issues
• Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments
• Partners with CRO and other vendors to deliver on study execution
• Creates and tracks clinical program budgets
• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)
• Builds relationships with clinical sites, vendors, and key stakeholders
• Maintains understanding of external landscape and adjusts plans accordingly
• Represents Clinical Operations in cross-functional activities as assigned
• Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned
• Hires, manages, coaches, and mentors staff
• Contributes to building the organization.

Senior Director, Clinical Operations

Research Scientist

• Lead immunology-driven research strategy across pipeline programs to support scientific narrative and indication assessment, integrating literature, experimental data, and translational insights
• Design and oversee mechanism-of-action studies to elucidate target biology, pathway modulation, and disease relevance across in vitro, ex vivo, and in vivo models, executed in partnership with CROs
• Partner closely with Translational Medicine, Clinical Pharmacology, and Nonclinical teams to ensure alignment of preclinical findings with clinical strategy
• Generate and interpret complex datasets (e.g., cellular immunology, cytokine profiling, pathway analysis), ensuring rigorous and hypothesis-driven conclusions
• Identify and validate new targets and pathways for pipeline expansion, leveraging deep understanding of disease biology, emerging science, and internal platform capabilities
• Evaluate and prioritize new indication opportunities, integrating mechanistic rationale, competitive landscape, and translational feasibility
• Support external collaborations and CRO activities, providing scientific direction and technical oversight to ensure high-quality data generation
• Author and contribute to scientific documents, including study reports, regulatory sections (e.g., IND-enabling rationale), presentations, and publications
• Present findings to internal governance teams and external scientific forums
• Stay current with advances in immunology, inflammation, and translational science, applying new insights to strengthen program and pipeline strategy

Principal Scientist, Immunology

Compliance

• Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications.
• Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.
• Conduct regulatory review of product documentation intended for submissions to ensure accuracy, consistency, and compliance with FDA and global regulations.
• Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
• Manage the processing, formatting, and operational aspects of regulatory submissions, ensuring compliance with regulatory requirements and internal quality standards.
• Identify regulatory risks proactively and contribute to risk-benefit assessments and mitigation strategies.
• Maintain up-to-date knowledge of US and global regulations, guidance documents, and evolving regulatory expectations.
• Monitor the external regulatory landscape and communicate potential impacts to internal stakeholders.
• Support continuous improvement initiatives to enhance regulatory compliance, efficiency, and documentation quality.
• Provide regulatory input into clinical study planning and execution, including identification of regulatory requirements and expectations, as a member of operational study teams.

Manager, Regulatory Affairs

QA Engineer

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.
• Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Executive Director – Clinical Quality Assurance

Legal Assistant

• Provide high-level administrative and operational support to the Chief Legal Officer and other Executives
• Manage and maintain complex calendars for the Chief Legal Officer and other Executives as assigned
• Coordinate travel arrangements, including itineraries, logistics, and expense reporting
• Serve as a liaison between leadership and internal/external stakeholders
• Upload Board and Committee materials to Boardvantage
• Coordinate execution of legal documents and deliverables in a fast-paced environment
• Maintain legal documents, files, and records with strict confidentiality
• Assist with compliance tracking, audits, and filings as needed
• Support cross-functional initiatives and projects
• Help manage department budgets, invoices, POs, and vendor relationships

Executive Assistant – Legal, HR, CMC

• Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, manufacturing (cell bank, DS, DP, FDP), and disposition of clinical materials
• Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest, stability protocols/reports, master batch records, method qualifications, etc.
• Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery of products and compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations
• Supports archival of documents/records, quality metrics and develop/maintain QA related tracking logs
• Work directly with operating entities (internal and CMOs) to ensure that product(s) meet all required quality standards and specifications
• Supports management of Quality Agreements, including project coordination, cross-functional review, and approval workflows
• Represent the Quality function in product development (CMC) teams to provide proactive quality guidance and decisions
• Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide the highest level of quality services to Jade
• Lead quality risk management activities to proactively identify, assess, and mitigate GMP-related risks across manufacturing and supply operations
• Facilitate resolution of quality issues with internal and external parties in a timely manner
• Coordinate communications with CMOs and internal technical product teams on quality issues
• Review CMC sections of regulatory filings, as needed
• Collaborate cross-functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities
• Participate in and support regulatory authority inspections and internal audits
• Supports development/maintenance of Quality SOPs
• Contribute to the development and maintenance of a positive team-focused company culture
• Other duties, as assigned

Director, GMP Quality Assurance

• Reporting to the Executive Director of Clinical Partnerships & Engagement, the Regional Site Liaison (RSL) is a field-based operational and scientific partner who serves as a critical link between Jade and clinical trial sites.
• Build and maintain strong relationships with Principal Investigators (PIs), site staff and KOLs in support of planned and active clinical trials.
• Organize and execute in-person visits with PIs and site teams.
• Serve as the Jade primary point of contact for regionally assigned clinical trial sites across one or more programs.
• Provide protocol support to Investigators and site teams.
• Support and reinforce site accountability of enrollment targets.
• Respond promptly to site inquiries outside of CRA scope, with appropriate cross-functional escalation as needed.
• Identify and resolve site challenges efficiently, delivering a high level of service.
• Partner with internal teams and CRO to develop and execute tailored site engagement strategies.
• Gather and communicate field insights to internal Jade team, including performance metrics and other KPIs, protocol feedback, and competitive trial activity.
• Provide regular updates to Clinical Operations on site-level enrollment plans and performance to support global enrollment strategy and consistent trial execution.
• Maintain alignment with Clinical Operations, Clinical Development, Medical Affairs, and CRO partners (including CRAs).
• Support site initiation, activation and ongoing trial conduct as requested by Clinical Operations, including co-monitor with CRA where appropriate.

Director, Regional Site Liaison

• Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
• Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
• Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk
• Drive initiatives to ensure continuous inspection readiness across clinical studies
• Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
• Support development of inspection storyboards and response strategies when needed
• Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance
• Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
• Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
• Participate in vendor governance meetings and performance reviews
• Identify trends or risks in vendor performance and recommend mitigation strategies
• Review and track vendor QEs
• Develop processes for oversight of monitoring activities conducted by CROs
• Review monitoring oversight plans, reports, and monitoring metrics
• Assess monitoring quality and compliance with monitoring plans
• Identify monitoring gaps and collaborate with study teams to address them
• Support identification and management of investigator or site non-compliance
• Assist study teams in evaluating protocol deviations and escalation needs
• Help develop remediation strategies for significant compliance issues
• Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
• Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
• Track CAPA effectiveness and ensure timely closure
• Identify recurring issues and support continuous improvement initiatives
• Partner with QA to support internal and external GCP audits
• Assist with audit preparation and documentation review
• Support study teams in addressing audit findings
• Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
• Identify knowledge gaps and support development of compliance training programs
• Contribute to SOPs, guidance documents, and best practice materials.

Director, Clinical Compliance

• Architect and lead the company’s global approach to clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across our clinical trial portfolio.
• Define Jade’s global investigator grant philosophy, including structured opening offer and negotiation parameters.
• Establish standards for invoiceables, conditional procedures, pass‑through costs, and country‑specific budgeting norms applicable across all Jade clinical studies.
• Oversee a full-service CRO partner responsible for operational execution of budgets, payments, reconciliation, and study financial controls.
• Build and maintain global site budget forecasts, ensuring just‑in‑time CRO funding, and support accruals, reconciliation, and inspection‑readiness.