Dianthus Therapeutics, Inc.

• Lead formulation development strategy for a new bispecific fusion protein from preclinical stage through clinical development. • Design and execute studies to assess protein stability, aggregation, degradation pathways, viscosity, and developability under relevant formulation conditions. • Develop liquid and, where appropriate, lyophilized formulations to support both IV and SC presentations. • Lead excipient screening, buffer optimization, pH optimization, surfactant selection, and stress stability studies to identify robust drug product formulations. • Drive high-concentration formulation development for subcutaneous delivery, including syringeability, injectability, and device compatibility assessments. • Partner closely with Analytical Development to establish appropriate characterization methods for formulation screening, stability assessment, and comparability studies. • Collaborate with Drug Substance, Process Development, Quality, Regulatory, Clinical Supply, and external CDMOs to ensure alignment between formulation strategy, manufacturability, and clinical needs. • Provide technical leadership for drug product process development, fill-finish considerations, container closure selection, and tech transfer activities. • Serve as the formulation subject matter expert during regulatory interactions and contribute to CMC sections of regulatory filings, including IND, IMPD, and BLA submissions. • Identify formulation-related risks early and develop mitigation strategies to support program timelines and long-term product quality. • Evaluate and implement new technologies and platform approaches to improve formulation development capabilities for complex biologics.

• Work across the regulatory team supporting all document management activities • Support implementation and maintenance of Regulatory Information Management System across all programs. • Archive regulatory submission documents, content plans and health authority queries for easy searching and retrieval • Own and maintain document repositories, trackers and dashboards, providing up to date, accurate information as a communication tool within R&D • Authoring of departmental documents including SOPs to support the systems and processes used in Regulatory Affairs and Regulatory Development Plans • Support departmental initiatives, including process and infrastructure development, regulatory intelligence, and budgeting

• Lead the clinical vendor procurement and outsourcing strategy across development programs, partnering closely with Clinical Development Operations, Finance, Legal, and other stakeholders • Oversee end-to-end vendor selection activities, including RFI/RFP development, bid analysis, bid defense management, vendor recommendation, and onboarding • Negotiate and manage vendor scopes of work, budgets, contracts, change orders, and purchase order readiness to support timely study execution • Establish and maintain strong vendor governance processes, including KPIs, business reviews, issue escalation, and performance improvement plans • Drive cost optimization, spend visibility, forecasting, and financial discipline across vendor engagements while balancing quality, speed, and compliance • Partner with study teams and cross functional stakeholders to assess service needs, support sourcing decisions, and ensure vendor capabilities align with program and portfolio priorities • Develop and standardize procurement processes, tools, templates, and ways of working to enable scalable and efficient clinical operations • Monitor industry trends and best practices in clinical outsourcing, procurement, and vendor management to continuously improve Dianthus’ operating model • Develop clear, concise, and executive-ready communications, including presentations for senior leadership

• Oversee and direct relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies at a regional or global level • Influence, oversee and support or lead the planning, budgeting, and study management processes in global clinical studies. • Leads and supports internal cross functional colleagues to successfully manage external service providers including CRO(s), vendors and subcontractors responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget at a regional or global level. • Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans. • Creates or 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 studies/programs to optimize delivery. • Ensures efficient and effective communication and exchange of information across the project and reporting functions. • May participate in Clinical submission activities. • Lead or participate in clinical data review • 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 Affairs, Legal Affairs, and Business Development. • Represent the company at Investigator Meetings. • Other such duties may be determined or assigned.

• Work closely with the Safety team to support ongoing clinical trials. • Ensure patient safety and regulatory compliance throughout the drug development lifecycle. • Manage safety data and contribute to safety oversight. • Review adverse events, safety signals, and coordinate/contribute to SRC and DSMB meetings. • Work collaboratively with the pharmacovigilance team and cross-functional teams.

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III). • Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out. • Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.) • Provide expert guidance on quality risk management, issue escalation, and mitigation strategies. • Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors. • Ensure effective oversight of delegated activities, including monitoring, data management, and safety management. • Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends. • Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits. • Align audit strategy with clinical milestones and BLA readiness. • Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution. • Ensure data integrity principles (ALCOA++) are embedded across clinical programs. • Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation. • Participate in regulatory inspections as a QA subject matter expert. • Act as a trusted advisor to Clinical Development and Operations leadership. • Drive a culture of quality, compliance, and continuous improvement. • Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components. • Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs. • Lead or contribute to quality governance forums and risk review boards. • Identify and assess systemic quality risks and compliance gaps • Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings. • Escalate critical risks to senior leadership with clear, risk-based recommendations. • Additional duties may be identified by functional management based on current project/business objectives. • Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

• 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 Vice President, Clinical Development 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.

• Lead and manage clinical data review activities across assigned studies. • Actively participate in data review and protocol deviation review meetings. • Collaborate with CROs to oversee data cleaning, query resolution, and database lock processes. • Review clinical data, data listings, and reports to identify inconsistencies, trends, and potential issues. • Identify, assess, and escalate data anomalies and protocol deviations. • Partner with Clinical Development Operations, Clinical Development, Data Management, and Biostatistics to ensure data quality and compliance. • Develop and implement data review plans and contribute to data management plans. • Support Data Management activities (e.g., CRF design, User Acceptance Testing) • Participate in CRO 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.

• Provide leadership and strategic direction for regulatory CMC deliverables, including drug/device combination products • Identify, communicate, and propose resolutions to routine and complex strategic issues • Lead planning and provide hands on support for development, and on-time delivery of clear and effective global CMC regulatory submission documents • Act as primary contact with Health Authorities for CMC-related matters; lead preparation for and conduct of agency meetings • Maintain expert knowledge in US and international biopharmaceutical and combination product regulations and provide proactive regulatory intelligence • Review and provide regulatory assessments on change controls • Identify regulatory opportunities and risks and communicate them to project teams and senior management in a clear and concise manner • Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance • Identify, engage and collaborate with external regulatory experts and consultants • Support departmental initiatives, including process and infrastructure development, budgeting, and authoring of departmental documents, such as SOPs and Regulatory Development Plans

• As the Senior Accountant you will have a direct impact on accounting and reporting activities for a fast-growing, public biotech. • Reporting to the Director, Accounting, you will be responsible for (i) assisting with monthly and quarterly close activities such as preparation of journal entries, reconciliations, financial analyses, supporting documentation and financial statements, • (ii) assisting with systems implementations, including potential new ERP, • (iii) assisting with management and execution of our independent audit and Sarbanes-Oxley activities, and • (iv) supporting other activities such as clinical trial accruals and collaboration arrangements. • Complete monthly and quarterly account reconciliations to ensure accurate reporting and ledger maintenance including but not limited to cash, accounts receivable, accounts payable, general ledger, fixed assets, payroll, prepaids, and purchasing. • Assists with the Sarbanes-Oxley activities including updating system documentation, testing controls, remediating control deficiencies and coordination efforts with the auditors. • Assists with completion of audit requests related to the annual audit and quarterly reviews. • Assists with 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. • Prepares specialized analyses in support of all business functions. • Potential management of future team members including but not limited to activities of mentoring, training and embodying a continuous improvement mindset. • Assists with specific projects and initiatives unique to a fast-growing biotechnology start-up, such as system implementations, updates and business process improvements and other ad hoc projects.