Dianthus Therapeutics, Inc.

Director

• 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.

Associate Director, Biologics Formulation Development

Compliance

• 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

Regulatory Information Manager

Clinical Operations

• 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.

Associate Director, Clinical Operations

• 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.

Associate Director, Biologics Formulation Development

Regulatory Information Manager

Associate Director, Clinical Operations

Associate Director, Pharmacovigilance