Associate Director, Clinical Operations
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
The Associate Director, Clinical Outsourcing should possess a Bachelor's degree and have at least 7 years of experience in clinical outsourcing, vendor management, or a related field. Strong negotiation skills and experience with contract management are essential, along with the ability to manage budgets and drive effective vendor selection and oversight. Familiarity with clinical trial operations and a solid understanding of outsourcing strategies are also required.
The Associate Director, Clinical Outsourcing will lead outsourcing and vendor management at a program level, fostering long-term relationships with vendors and collaborating with clinical operations leads. They will manage the contract lifecycle, create partnerships with vendors, develop scope of work documents, and actively negotiate rates with CROs to ensure fiscal responsibility. This role involves assessing risk, developing contracts, communicating with internal and external stakeholders, overseeing vendor performance, and negotiating Clinical Trial Agreements (CTAs) and Site Budgets with institutions in the United States and Canada, as well as tracking investigator grant budgets across all clinical programs.
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.