Manager/Senior Manager, Clinical and PV Quality

Axsome Therapeutics•New York, NY

11d•$120,000 - $140,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a scientific discipline or field
5+ years of experience within the pharmaceutical and R&D industry, of which a minimum of 3 years hands-on GCP and/or GVP QA experience.
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.
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.

Nice To Haves

Experience of hosting or managing GCP and/or GVP inspections is desirable.
Experience in clinical operations and handling trial essential documents is preferred.

Responsibilities

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).