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 Alzheimers 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 brains biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on and .
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 Axsomes 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
Job Responsibilities and Duties include, but are not limited to, the following:
- Partner with key functions (Clinical Operations, Pharmacovigilance) and interface functions (e.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.
- Provide GCP / GVP 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.
- Execute GCP / GCP-GcLP / GVP internal audits (i.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.
- Review and provide input to clinical documentation (e.g. protocols, study reports, IB etc.)
- Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance, and Pharmacovigilance systems and standards.
- Develop and measure GCP and GVP 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.
- Provide information relating to Quality to stakeholders, as required (e.g. PV System Master File).
Requirements/ Qualifications
Experience, Knowledge and Skills
- Experience in a compliance role.
- Extensive knowledge and practical application of ICH, GCP / GVP and applicable guidance documents.
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
- Experience of hosting or managing GCP and/or GVP inspections is desirable.
- Experience in clinical operations and handling trial essential documents is preferred.
- Proficient MS Office skills.
- Excellent planning and organizational skills.
- Exceptional attention to detail.
- Strong interpersonal skills and a team player.
- Ability to influence senior leaders within the organization on matters of quality importance.
- Effective communication skills, both verbally and written.
- Proven ability to manage complex projects.
Salary & Benefits
The anticipated salary range for this role is $120,000 - $140,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
