
Jade Biosciences
Remote Jobs
On a mission to transform the future of autoimmune care
13 Jobs
Director, Clinical Compliance
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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, GMP Quality Assurance
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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
Principal Scientist, Immunology
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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
Director, Regional Site Liaison
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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.
• 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.
Executive Assistant – Legal, HR, CMC
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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
Senior Executive Director, Quality Management System
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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.
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Role Overview We are seeking a Manager, Accounting to assist in monthly, quarterly, and year-end closing processes focused heavily on R&D accruals (primarily clinical and CMC). The Manager, Accounting will also support the day-to-day functions of the Finance and Accounting team with a focus on streamlining processes and creating efficiencies. The Manager, Accounting will report to the Assistant Controller. Key Responsibilities - Assist in the timely month-end, quarter-end, and year-end closing processes including balance sheet and operating statement account reconciliations, journal entries, and accruals - Work directly with Assistant Controller, Controller, Clinical and CMC teams, and vendors to accurately and efficiently report accruals on a monthly basis - Assist business leaders in preparing clinical and CMC accrual files, inquiring with vendors, and holding monthly inquiries with business owners - Analyze financial statement accounts, identify unusual trends or erroneous entries, and verify accuracy of transactions and balances - Aid in the updating of business process walkthroughs and flow-charts as well as perform periodic controls procedures - Prepare payroll and work closely with HR function to ensure proper reporting and classification - Oversee equity administration and working with HR and Legal functions to accurately report all equity transactions - Potential management of future team members including but not limited to activities of mentoring, training and embodying a continuous improvement mindset - Perform ad hoc projects Qualifications - Bachelor’s degree and 5+ years of related accounting experience, specific experience in Biotech / Life Sciences are required - Experience establishing processes for Clinical and CMC accruals and performing ongoing assessments in line with monthly, quarterly, and annual closes is required - Strong operational accounting skillset and demonstrated success - Master’s degree and CPA certification a plus - Strong understanding of GAAP, and internal controls - Thorough understanding of Sarbanes Oxley and public company requirements - Experience performing and documenting monthly close processes and maintaining supporting documentation for financial transactions - Excellent problem-solving skills, with keen attention to detail and financial analysis knowledge - Stellar collaboration and communication skills and ability to work cross functionally with all levels of the organization - Strong organization and prioritization skills that ensure challenging deadlines are met with high quality output - Ability to critically think through situations and problem solve independently Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $130,000 - $140,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Associate Director, Clinical Site Budgets & Payments
Jade BiosciencesOn a mission to transform the future of autoimmune care
• 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.
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Role Overview The Director of Program Management (PM) will lead and deliver comprehensive program management support across one or more drug development programs, ensuring alignment with cross‑functional strategic and operational objectives. This individual will serve as the program’s operational leader—driving execution so that all deliverables are met on or ahead of schedule, within budget, and in accordance with organizational goals. Success requires exceptional attention to detail, strong forward‑planning and organizational capabilities, and the ability to effectively engage, influence, and manage stakeholders across diverse teams. This position is fully remote and will report to the VP and Head of Portfolio Strategy and Management (PSM). Periodic travel to team and company events is required. Key Responsibilities - Leads the cross functional development of integrated program plans in partnership with the Program Team Leads, and ensures alignment with the overall program strategy - Collaborates with functional leads to ensure effective teamwork and execution of cross-functional deliverables - Develops and maintains program-level integrated development plans reflective of program strategy, critical path milestones and key interdependencies across functions - Tracks program risks by proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success - Drives decision point planning, ensuring the associated deliverables across all functions are met, and contributes to the strategic planning process - Ensures effective, accurate, and timely communication of program information to meet the needs of the program team and stakeholders - Provides cross-functional operational leadership to the team - Partners with the PSM organization to support development and refinement of processes, tools and systems to deliver high quality PM support to the programs and the broader organization Qualifications - Bachelor's degree in a related field required; advanced degree preferred - 15+ years of experience in program, project or alliance management within the biotech or pharmaceutical industry - Strong experience in providing program management to cross-functional teams - Excellent organizational skills and ability to forward-plan - Proven track record of successful project management of complex drug development programs in a fast-paced startup environment - Expertise with project management tools (e.g. Smartsheet, Microsoft Timeline Pro+) - Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment - Proactively identify issues and drive resolution; can anticipate key future events and adjust team priorities/plans accordingly - Excellent communication and interpersonal skills with the ability to influence and motivate cross-functional teams, manage a diverse set of stakeholders, and work closely with team leaders - Strong written and oral communication skills with strong attention to detail Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $220,000 - $240,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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