Axsome Therapeutics Inc

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

United States

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

Position Overview

  • Location Type: East Coast
  • Employment Type: Full Time
  • Job Description Summary: The Director, Global Medical Services Operations enhances the provision of premium medical services and underlying processes that are fundamental to success. Critical to both internal and external customers, Medical Services is a vital support function that contributes towards the successful utilization of PTC products. Working with colleagues, and cross-functionally with internal departments, external resources, and vendors, the incumbent implements, directs, coordinates, monitors adherence to, and improves essential processes, based on regulatory requirements, as well as company policies, goals and objectives. The Operations Director, Global Medical Services supports Regional Heads with adherence to relevant regulatory requirements and compliance with company Standard Operating Procedures (SOPs) as appropriate, to ensure a continued state of inspection readiness. They enhance the effectiveness of our external relationships and collaborations with essential third parties, stakeholders and resource providers, who are central to the continuous delivery of a high quality, scalable and efficient service that can adapt and grow in alignment with business needs.

Responsibilities

  • Maintains active oversight of the entire Medical Services inquiry handling operations across all regions; ensuring a global state of continuous inspection readiness.
  • Increases the efficiency of existing processes and procedures to enhance the optimization and success of service delivery.
  • Recognizes process improvement opportunities and implements changes to boost service, infrastructure, and human resource effectiveness.
  • Identifies non-adherence to processes swiftly and proactively proposes and implements strategies to optimize and refine processes that are inefficient, cumbersome, or obsolete.
  • Builds close relationships with cross-functional teams to improve communication and establish best collaborative practices that enable stakeholder functions to fulfil their regulatory obligations. This includes establishing solid connections with Compliance, Legal, Pharmacovigilance and Quality departments (and other stakeholder functions) to ensure that activities and processes remain consistently aligned with, complementary to, and add value to, the respective obligatory functional requirements. This expectation applies at a global, regional, and local country level. Examples include complying with GxP activities, and all applicable safety, quality, and data privacy legislation, whilst also considering company policies and local codes of conduct where necessary.
  • Assumes global responsibility for contracting, managing, and monitoring third party vendors that are partnered with the company as additional resource to deliver core Medical Services. This includes supporting regional medical services leads with onboarding contractors, launching new front-

Requirements

  • (Details are missing in the provided job description)

Application Instructions

  • (Details are missing in the provided job description)

Company Information

  • (Details are missing in the provided job description)

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.

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.

Land your dream remote job 3x faster with AI