Dianthus Therapeutics, Inc.

Director

• 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.

Senior Director, Clinical Development

Accountant

• 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.

Senior Accountant

Communications

• Lead the redesign and ongoing evolution of the company’s external website to reflect brand, strategy, and scientific innovation.
• Ensure the website serves as a best-in-class platform for storytelling, recruiting, investor visibility, and patient education and engagement.
• Develop and implement a forward-thinking internal communications strategy aligned with the company’s mission, vision, and values.
• Design and execute a comprehensive internal communications approach for a fully remote workforce that drives engagement, clarity, and connection.
• Create and manage a dynamic, year-round internal communications and employer brand calendar that proactively aligns messaging with business priorities, milestones, and organizational needs.
• Craft and deliver executive communications that reflect leadership voice, company values, and business priorities.
• Enhance and update our corporate brand image via refresh of look and feel, taglines, and corporate narrative to reflect position as an innovative, late-stage biotech company.

Vice President, Corporate and Internal Communications

Compliance

• 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 (eg, 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 (eg, SOPs and Regulatory Development Plans).

Senior/Executive Director, Regulatory Affairs

Project Manager

• Provide hands-on leadership to support integrated project planning across the full lifecycle of drug development.
• Create, maintain, and drive detailed, cross-functional project plans aligning various activities.
• Serve as a central operational integrator, working closely with cross-functional teams.
• Mentor and provide day-to-day guidance of junior project managers while focusing on detailed execution.

Senior Director, Clinical Development

Senior Accountant

Vice President, Corporate and Internal Communications

Senior/Executive Director, Regulatory Affairs

Executive Director / Vice President, Project Management