Dianthus Therapeutics, Inc.

Accounting Manager

• Manages and/or prepares, analyzes, and reconciles all financial statements and related reports including but not limited to balance sheets, income statements, cash-flow reports, budgets, and variance analysis.
• Manages all accounting functions including but not limited to accounts receivable, accounts payable, general ledger, fixed assets, payroll, and purchasing.
• Manages the Sarbanes-Oxley activities including updating system documentation, testing controls, remediating control deficiencies and coordination efforts with the auditors.
• Provides senior management with timely reviews of organization's financial status and progress.
• Coordinates audit activities related to the annual audit and quarterly reviews.
• Establishes, modifies, and coordinates the implementation of accounting systems, policies, and procedures.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Manages or prepares specialized analyses in support of all business functions.
• Directly or indirectly supervises 1-2 employees within the finance department.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Director, Accounting

Compliance

• Support the Director in coordinating and implementing study startup activities in collaboration with CROs and internal study teams.
• Assist in identifying country-specific regulatory and ethics committee requirements to facilitate timely CTA approvals.
• Review and prepare submission packages for Regulatory Authorities and IRB/IEC for completeness and accuracy.
• Ensure required Quality documentation (e.g., QP declaration, GMP Certification) is available for drug release.
• Track and coordinate responses to Regulatory and IRB/IEC queries and deficiency letters with subject matter experts.
• Monitor and report on CTA status updates and study startup progress across assigned projects.
• Maintain internal regulatory files and ensure documentation is complete and accessible.
• Support the review and maintenance of the Trial Master File for regulatory and ethics committee documentation.
• Update global clinical trial registries (e.g., ClinicalTrials.gov) as required.
• Participate in Study Management Team meetings to represent regulatory/study startup perspectives.
• Assist in gathering and sharing regulatory intelligence related to study startup.
• Contribute to the development and maintenance of SOPs and process improvement initiatives.
• Support strategic planning and risk mitigation efforts related to study startup activities.
• Travel up to 10% for team meetings and company events.

Manager, Regulatory Clinical Applications

Operations

• Help lead and optimize operational aspects of pharmacovigilance across multiple clinical programs.
• Responsible for vendor relationships, ensuring compliance with global safety regulations, and managing critical processes that support patient safety and regulatory reporting.
• Oversee case processing activities, including intake, triage, and timely reporting of adverse events.
• Maintain and monitor trackers for lab values and other safety-related data to ensure accurate and timely updates.
• Ensure vendor compliance with contractual obligations, timelines, and quality standards.
• Provide operational expertise during audits and inspections.
• Ensure adherence to global PV regulations (FDA, EMA, ICH) and company SOPs.

Manager/Senior Manager, Drug Safety Operations

Medical Director

• Serve as the safety physician lead for designated Dianthus’s product.
• Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, ensuring appropriate coding and compliance with global regulations.
• Perform aggregate data analysis and interpretation.
• Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate.
• Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments.
• Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports.
• Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues.
• Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions
• Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies.
• Support internal and external pharmacovigilance audits and regulatory inspections.
• Stay current with global pharmacovigilance regulations, guidelines, and best practices.

Medical Director, Drug Safety and Pharmacovigilance

Manager

• Work collaboratively with the CMC organization to solve complex analytical problems.
• Support activities related to clinical drug substance and drug product stability studies.
• Provide technology development, strategic leadership, and technical expertise in methods development.
• Collaborate cross-functionally to ensure timely and successful development of pipeline drug candidates.
• Assist in monitoring contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database.

Senior Manager, Biologics Analytical Research and Development

Director

• Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
• Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
• Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
• Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements.
• Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
• Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions.
• Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
• Evaluate and implement new technologies to enhance upstream development capabilities.

Director, Drug Substance – Early Development

• Lead and manage clinical data review activities across assigned studies.
• Collaborate with internal colleagues, clinical trial sites, and external vendors / partners to support data cleaning, query resolution, and database lock processes.
• Review clinical data platforms, listings and reports to identify inconsistencies, trends, and potential issues and communicate and / or present findings, trends or analyses to relevant cross functional team as required.
• Review, from a medical and clinical aspect, data, anomalies and protocol deviations and communicate and / or present findings, trends or analyses to relevant cross functional team as required.
• Partner with cross functional teams including Clinical Operations, Clinical Development, PV, Data Sciences and Biostatistics to ensure data quality and compliance.
• Contribute to, and implement, data review plans and contribute to data management plans.
• Participate in vendor oversight, including performance monitoring and issue resolution.
• Support audit readiness and regulatory inspections by ensuring data traceability and documentation.
• Mentor junior team members and contribute to process improvement initiatives.

Associate Director, Data Review

• Managing the monthly book closing activities such as preparation of journal entries, financial analyses, supporting documentation and financial statements.
• Assisting with SEC reporting and technical accounting activities.
• Assisting with the management and execution of the independent audit and Sarbanes-Oxley activities.
• Supporting other activities such as the administration of share-based compensation programs, management of collaboration arrangements, etc.
• Keeping up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Assisting with the implementation of accounting systems, policies, and procedures.

Senior Manager, Accounting

QA Engineer

• Develop and execute the company’s QA strategy across drug and device development and manufacturing.
• Lead and scale the QA team, including specialists in pharmaceutical and medical device quality.
• Ensure compliance with FDA, EMA, and other global regulatory requirements for combination products as applicable to Dianthus clinical studies (21 CFR Part 210, 211, 4 & 820, ISO 13485, etc.).
• Oversee the Event (deviation, complaint, issue) and Corrective/Preventive Action (CAPA) process.
• Support the Quality Compliance Sr. Director with supplier and contract manufacturer audits, qualification, and ongoing performance monitoring.
• Guide technical development quality oversight—provide quality input to process development, technology transfer, comparability and stability strategies; approve key technical protocols and reports.
• Represent QA on governance forums (Change Review Board, Inventory & Operations – I&OP, CMC Team Review, Design Review Committee) and during health authority inspections as the primary product quality contact.
• Support regulatory submissions (IND, BLA, IDE, PMA) and serve as QA lead on submission reviews.
• Collaborate cross-functionally with Clinical, Regulatory, CMC, and Engineering teams to embed quality in a phase-appropriate manner.
• Provide QA support to nonclinical studies as needed (e.g. perform GLP audit of toxicology study protocols and reports).
• Drive continuous improvement initiatives and foster a culture of quality, accountability, and collaboration.
• Additional duties may be identified by functional management based on current project/business objectives.

Executive Director, CMC Quality Assurance

• Represent regulatory on cross-functional teams; provide leadership and strategic direction for regulatory deliverables.
• Lead planning and provide hands-on support for development and on-time delivery of clear and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents.
• Identify, communicate, and propose resolutions to routine and complex strategic issues.
• Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s).
• Maintain expert knowledge in US and international regulations and provide proactive regulatory intelligence.
• Assess opportunities and oversee applications for expedited pathways (e.g., fast track or breakthrough designation or PRIME) and/or orphan drug designations.
• Lead preparation for and conduct of Health Authority meetings.
• Evaluate competitive landscape, regulatory approval pathway(s), and labeling precedent(s).
• Identify, engage and collaborate with external regulatory experts and consultants.
• Perform regulatory strategic assessments for new product candidates and new indications.
• Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (e.g., SOPs and Regulatory Development Plans).

Senior Director, Regulatory Affairs

• Play a critical role in defining and driving regulatory compliance of biologics-device combination products across their development lifecycles.
• Collaborate with device development, device quality, and CMC Team SMEs to support the development and commercialization of therapeutic products for rare diseases.
• Develop comprehensive strategies that address both biologic and device components and align with corporate goals and regulatory expectations.
• Provide guidance for plans and protocols for compatibility studies, design verification studies and functional stability studies, and contribute to the design of human factor studies and usability testing.
• Interpret regulatory regulations, standards, directives, guidelines and advise Development, Technical Operations, and Quality on their applicability to and impact on product development projects.
• Deliver strategic input to Design Control processes and documentation, ensuring alignment with health authority and notified body requirements and global technical standards.
• Design and execute effective submission strategies for device-related dossier components in collaboration with SMEs.
• Conduct precedent research to ensure creation of state-of-the-art studies.
• Perform assessment of change controls to identify and mitigate regulatory risks.
• Lead interactions with health authorities and notified bodies.
• Help manage device-related regulatory information in company systems.
• Support other Regulatory CMC activities.

Senior Director, Regulatory Combination Product

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Clinical Development program lead by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders
• As a medical specialist, supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

Director, Clinical Development Scientist

Clinical Operations

• Oversee and direct relevant clinical operations resources while also contributing to strategy, tactics, and driving execution of multiple global clinical programs.
• Influence, oversee and lead the planning, budgeting, and study management processes in global clinical studies.
• Leads direct reports to successfully manage external service providers including CRO(s), vendors and subcontractors, in addition to internal cross-functional colleagues responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget.
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies.
• Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department.
• Review, assess and manage resource strategies with internal and external groups for global drug development programs, working strategically with suppliers/CROs.
• Manage relationships with pharmaceutical partners and suppliers in clinical programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across projects and reporting functions.
• Leads/participates in clinical data review.
• Participates in Clinical submission activities.
• May serve as the clinical operations representative at regulatory agency meetings.
• As needed, participates in due diligence activities for in-licensing opportunities.
• Develop training plans, act as mentor and conduct performance reviews for all direct reports.
• Supports the development and implementation of department level SOPs for clinical trials and related activities.
• Interface with departments within and outside of Clinical, including Finance, Regulatory Affairs, Legal Affairs, and Business Development.
• Represent the company at Investigator Meetings.

Senior Director, Clinical Operations

Clinical Research

• The Senior Clinical Trial Manager/Associate Director will be responsible for the oversight, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional or global level.
• You will report the Executive Director, Clinical Development Operations and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager/Associate Director, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus, in particular, in leading the delivery of our ongoing global Phase III CIDP study and additional regional support for the planned phase III study. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be responsible to oversee and manage internal and external resources to ensure efficient patient recruitment/management, trial site selection/management, trial plan optimization and overall execution with a focus on quality.

Senior Clinical Trial Manager / Associate Director

• Manage and support relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies.
• Influence, manage and lead the planning, budgeting, and study management processes in global clinical studies.
• Accountable for oversight and management of CRO/vendor partners contracted to the study / region assigned
• Leads and supports the cross functional study team to successfully manage external service providers functional counterparts (including CRO(s), vendors and subcontractors), to ensure project deliverables are executed on time and within budget, whilst also taking on clinical trial management (CTM) role as needed.
• Leads/participates in clinical data review
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies.
• Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department.
• Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across projects and reporting functions.
• May participate in Clinical submission activities.
• Supports the development and implementation of department level SOPs for clinical trials and related activities.
• Interface with departments within and outside of Dianthus including Finance, Regulatory, Quality, and Tech Ops.
• Represent the company at Investigator Meetings.
• Other such duties as may be determined or assigned.

Senior Clinical Trial Manager – APAC

Project Manager

• Support CMC and technical operations teams, to ensure that deliverables are completed on schedule, within scope and budget, and aligned with program goals.
• Own sample management processes, including tracking, shipment, inventory control, and documentation in compliance with regulatory and quality requirements.
• Coordinate cross-functional project teams, including analytical, process development, manufacturing, quality, regulatory, and supply chain functions to ensure alignment and progress.
• Develop and maintain detailed project plans, timelines, dashboards, and status reports.
• Facilitate effective communication between internal teams and external partners (vendors, CMOs, and CROs).
• Work collaboratively with PMs across functions to identify process improvements, optimize resource planning, and risk mitigation strategies.
• Proactively identify risks, issues, and dependencies, and escalate appropriately with mitigation recommendations.
• Support the preparation of project documentation, including meeting agendas, minutes, and decision logs.
• Track and report progress against milestones to senior management and program leadership.

CMC Project Manager

Program Manager

• Establishing and leading a centralized program management function across the organization.
• Overseeing the planning, execution, and delivery of all R&D and corporate programs.
• Ensuring alignment with strategic goals, timelines, and budgets.
• Designing and implementing a centralized Program Management Office to support all development programs.
• Providing strategic oversight and hands-on leadership for key programs across various functions.
• Integrating existing program management practices into a unified framework.
• Developing and maintaining portfolio dashboards, KPIs, and reporting mechanisms.
• Partnering with various departments to ensure program milestones are met.