Axsome Therapeutics Inc

Director, Global Medical Services Operations (East Coast Based Position)

United States

Axsome Therapeutics Inc Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

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.

Responsibilities

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.

Skills

Process Improvement
Regulatory Compliance
Cross-Functional Collaboration
Operational Oversight
Inspection Readiness
Vendor Management
Stakeholder Engagement

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

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.

Key Metrics

New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees

Benefits

Performance Bonus
Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.
Potential delays in AXS-07 launch amid growing market anticipation.
Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.
AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.
Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.
Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.
Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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