Sr Med Director - Hematology/Oncology(Remote U.S)
Thermo Fisher Scientific- Full Time
- Senior (5 to 8 years)
Axsome Therapeutics Inc
Candidates must be based on the East Coast and possess a strong understanding of regulatory requirements, compliance, and company Standard Operating Procedures (SOPs). Experience in managing third-party vendors and collaborating with cross-functional teams, including Compliance, Legal, Pharmacovigilance, and Quality departments, is highly desirable.
The Director, Global Medical Services Operations will maintain oversight of the entire Medical Services inquiry handling operations across all regions, ensuring a global state of continuous inspection readiness. They will increase the efficiency of existing processes and procedures to enhance service delivery, recognize process improvement opportunities, and implement changes to boost service effectiveness. The role also involves identifying non-adherence to processes, proposing and implementing strategies to optimize processes, building relationships with cross-functional teams, and assuming global responsibility for contracting, managing, and monitoring third-party vendors.
Develops therapies for CNS disorders
Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.