Manager/Senior Manager, Clinical and PV Quality

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.

Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. com and follow us on LinkedIn and X .

About This Role

Axsome Therapeutics is seeking a Manager/Senior Manager Clinical and PV Quality who will provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight of Axsome’s clinical trial activities and related records and processes to assure quality and management in accordance with key global regulations (FDA, Health Canada, EMA and MHRA), ICH guidance (GCP E6, E2 and other relevant guidelines), company processes (such as SOPs) and all other applicable regulations. The Manager/Senior Manager Clinical and PV Quality will manage cross functional relationships with internal and external stakeholders and be the lead Quality GCP and GVP representative on clinical teams for ongoing Axsome-sponsored trials and post-market activities. This position will report to the Senior Vice President, Quality.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Responsibilities

g. Medical Affairs and Commercial) to support a compliance journey; driving and achieving a “first time right” approach in relevant issue and initiatives. Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs and post marketing activities.

Requirements

input into the development and implementation of Quality (GxP) systems. Provides expertise and guidance on applicable regulations to specialty pharma/clinical development and pharmacovigilance teams, to proactively identify compliance issues/risks and recommend mitigation. Identify and address GCP / GVP compliance issues across Axsome clinical and pharmacovigilance systems and processes to ensure a state of readiness for regulatory inspection.

Develop and implement a risk-based GCP and GVP audit program. e. adherence to SOPs, company policies, and regulations/standards) or external audits (adherence to contractual agreements, plans and regulations / standards).

Develop and facilitate GCP/GVP/GXP training for functional areas and personnel involved in the execution of clinical trials and post marketing activities. Identify, monitor and report compliance trends and risks for trials and post market activities. Lead and support investigations into significant departures from GVP / GCP, including serious breaches / scientific misconduct.

Escalate compliance issues identified to senior management. g. ) Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance, and Pharmacovigilance systems and standards.