Dianthus Therapeutics

Lead the formulation development strategy for a new bispecific fusion protein from preclinical stages through clinical development. This includes designing stability studies, optimizing drug product presentations for IV and SC administration, and managing external CDMO partnerships.

The role involves developing and managing systems to track regulatory information and data throughout the product lifecycle. It also includes maintaining document repositories, authoring SOPs, and ensuring compliance with global health authority commitments.

Oversee the strategic direction and operational implementation of global clinical trials, ensuring compliance with ICH/GCP guidelines. Manage internal and external resources, including CROs and vendors, to optimize patient recruitment and trial execution.

The Associate Director will oversee pharmacovigilance activities for clinical programs, ensuring regulatory compliance and data integrity. They will also manage safety review meetings and collaborate with cross-functional teams on signal detection and risk assessment.

This role is responsible for building and leading a modern communications function, shaping internal and external communication strategies to strengthen employee engagement and elevate the corporate brand. Key duties include leading corporate communications, developing internal strategies for a remote workforce, crafting executive communications, and enhancing the corporate and employer brand image.