Senior Specialist/Manager
Clinical Quality
Posted on 11/9/2023
Axsome Therapeutics Inc

201-500 employees

Develops novel therapies for central nervous system conditions.
Company Overview
Axsome Therapeutics, Inc. stands out as a leader in the biopharmaceutical industry due to its dedicated focus on developing novel therapies for central nervous system conditions, an area with limited treatment options. The company's commitment to creating products that significantly improve patient lives demonstrates a strong, patient-centered culture. Its unique approach to treating CNS conditions through the development of therapeutic options with novel mechanisms of action showcases its technical innovation and competitive edge in the industry.

Company Stage


Total Funding





New York, New York

Growth & Insights

6 month growth


1 year growth


2 year growth

New York, NY, USA
Experience Level
Desired Skills
Google Cloud Platform
Quality Assurance (QA)
QA & Testing
  • A BA or BS degree in a scientific discipline strongly preferred
  • At least three (3) years’ experience (5 preferred) working in a GCP quality role in the pharmaceutical clinical research industry required
  • Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs
  • Identify and address GCP compliance issues across Axsome clinical systems and processes to ensure a state of readiness for regulatory inspection
  • Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policies, and regulations/standards, to include clinical study report audits and trial master file audits
  • Plan, conduct, oversee and tracking GCP and GcLP audits of external contract laboratories and CROs to assure compliance with internal procedures and regulatory guidelines
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and providing assessment of the impact of any deficiencies
  • Assist with ICH/GCP Training at investigator meetings and internally
  • Identify and monitor clinical compliance trends and risks for Axsome clinical trials. Escalate compliance issues identified to senior management
  • Review and provide input to clinical documentation (e.g. protocols, study reports, IB)
  • Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance systems and standards
  • Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization
  • Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable
  • Up to 10% travel may be required
  • Perform other work-related duties as assigned
Desired Qualifications
  • Experience in clinical operations and handling trial essential documents preferred
  • Additional experience conducting GMP/GLP audits a plus