Vice President, Clinical Quality

at  Neumora

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

JOB SUMMARY:

The Vice President, Clinical/Non-Clinical Quality supports the compliance oversight of Global Clinical Trials and Non-Clinical studies at Contract Research Organizations. Additionally, the incumbent is responsible for the establishment and maintenance of the Clinical and Non-Clinical Quality Management Systems (QMS) at Neumora to ensure that procedures and practices meet all applicable laws, regulations, and guidance as set forth by applicable Global Health Authorities.

QUALIFICATIONS & SKILLS:

• B.S./M.S. in relevant science field required
• PhD in relevant science field preferred
• 10-15 years of progressive global quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in clinical and non-clinical quality operations and quality systems development.
• Current and strong working knowledge of interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other global regulatory requirements governing clinical and non-clinical research.
• Global clinical trial oversight experience required.
• Non-clinical study oversight experience required.
• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
• Position requires a highly diplomatic, tactful, and detail-oriented individual with exceptional critical reasoning skills.
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
• Travel will be required between 30% and 40% of the time.
• Auditor certifications a plus.

• Oversee the development, implementation, and management of GCP and GLP related QMS SOPs and policies in compliance with all applicable laws and regulations.
• Ensure clinical trials and non-clinical studies are performed in accordance with applicable study protocols and global regulations as apply.
• Manage cQA/pQA departmental staff, consultants, and contractors.
• Manage and oversee all aspects of cQA compliance at clinical vendors.
• Manage and oversee all aspect of GLP compliance at non-clinical vendors.
• Create/manage/maintain quality plans for the cQA department.
• Perform and/or manage staff performing quality audits of investigator sites and clinical and non-clinical vendors.
• Perform and/or manage quality reviews of clinical study documents, which include but are not limited to investigator brochures, clinical protocols and clinical study reports, case report forms, informed consents forms, DSURs, clinical study plans, protocol deviations, and protocol amendments.
• Perform and/or manage quality reviews of non-clinical study documentation and data as required.
• Perform/manage internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and GCP regulations, standards, and guidelines.
• Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
• Support the administration of the company’s training program by overseeing the conduct of GCP/GLP training to internal departments and externally, as applicable.
• Manage/conduct targeted training of investigators/site staff.
• Report GCP/GLP related deficiencies and associated risks to executive management as well as plans for risk mitigation and corrective and/or preventive actions (CAPA).
• Assist clinical and non-clinical study teams in the development of risk mitigation plans and CAPAs.
• Assist with tracking GCP/GLP compliance audit trends and group metrics and presenting metrics-driven data to executive management.
• Coordinate responses to regulatory agency inspections.
• Review GLP and GCP sections and associated documents to regulatory submissions for clarity, accuracy, data integrity, and compliance to current applicable regulations.
• Participate on Core Teams as the cQA/pQA program lead.
• Create and drive performance to cQA/pQA goals and budgets