Associate Director, Clinical Operations
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
The Associate Director, Device Development should possess a strong understanding of biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This role requires experience working with external suppliers, manufacturers, and other functional areas within Technical Operations and Quality, ensuring the development and manufacture of high-quality combination products for clinical supply, commercial manufacturing, and regulatory submissions.
As a technical leader, the Associate Director will provide technical leadership on cross-functional teams responsible for the development of combination products, working with the Quality function to develop and refine the combination product quality management system. They will author product-specific design control documentation, including User Requirements Specifications, Design Input Requirements, and Design Verification plans, protocols, and reports, oversee test method development, test method validation, and design verification at external labs, and establish human factors strategies while collaborating with human factors service vendors to execute formative and summative HF studies.
Develops therapies for autoimmune diseases
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.