Associate Director, Clinical Operations
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
Candidates should possess a Bachelor's degree in a related scientific or healthcare field, and a combination of relevant experience is preferred. They must have a strong understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams. Strong communication and interpersonal skills are also required.
The Associate Director, Clinical Operations will independently manage all operational aspects of assigned clinical trials, with a focus on early-phase oncology studies, including overseeing CROs, vendors, and clinical sites across both U.S. and international regions. This role involves leading the planning and execution of complex Phase I oncology trials, ensuring compliance with regulations, managing external partners, conducting site visits, developing study documents, reviewing monitoring reports, providing guidance to team members, and collaborating with internal stakeholders to ensure smooth clinical program execution. They will also prepare study updates, represent Clinical Operations in meetings, and contribute to continuous process improvement, while being willing to travel up to 15% for site visits and conferences.
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.