ALX Oncology is looking for a full time Senior Director / Executive Director, Clinical Quality Assurance to join our team to establish an in-house Clinical Quality Assurance department that will work with our external Clinical QA contractors to support the clinical development of our investigational therapeutic candidates. The successful candidate will be located preferably in the San Francisco Bay area, however, a US West Coast (same time zone) resident is also acceptable. Ability to work at least part-time onsite at the South San Francisco office is preferred.

The Senior Director / Executive Director, Clinical Quality Assurance will report to the VP Regulatory and Quality and will establish and lead the Clinical Quality Assurance team within ALX Oncology. The successful candidate will provide GCP compliance oversight and leadership to ALX Oncology’s Clinical Development programs, will establish an in-house Clinical Quality Management System and a Clinical QA team that will provide expertise and guidance regarding regulatory requirements, GCP guidelines and Standard Operating Procedures (SOPs) for the conduct of clinical studies.

The Senior Director / Executive Director, Clinical Quality Assurance will utilize a risk-based strategy to prioritize GCP QA support for clinical trial activities, quickly identify/address compliance concerns, apply proactive decision-making, and, develop and execute effective and comprehensive action plans to address quality and compliance risks. In addition, the Senior Director / Executive Director, Clinical Quality Assurance will partner with Clinical Operations, Clinical Sciences, Regulatory, Pharmacovigilance, CMC QA, contract Clinical QA, and other key functions to assure transparency and escalation of quality and compliance matters.

The Senior Director / Executive Director, Clinical Quality Assurance will develop and implement Clinical Policies / Standard Operating Processes and Procedures as well as tools and templates to help ensure compliance with GCP and applicable regulatory requirements. Actual job title will commensurate with experience and skill sets.

Responsibilities:

• Lead Clinical Quality Assurance activities and work with Clinical Development team to ensure GCP and regulatory compliant clinical studies sponsored or supported by ALX Oncology.
• Lead / manage GCP audits, including qualification audits of GCP service providers, clinical investigative site audits, clinical department internal audits, and applicable study document audits, including review of TMFs and CSRs.
• Establish and manage study specific Clinical Study Audit Plan (CSAP) compliance by using risk-based approach for ALX clinical studies.
• Manage / oversee contract clinical QA team activities.
• Serve as a QA representative and support the clinical study teams to provide compliance advice during team meetings or through other methods of communication.

• Participate in review and approval of clinical study documents.

• Establish and continuously improve the Clinical Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP compliance.
• Lead and manage clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks.
• Lead and manage GCP inspection readiness activities.
• Lead / manage clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections.  Support GMP, GLP, and PV inspections, as required.
• Maintain knowledge of current regulatory agency and industry trends, standards and methodologies related to GCPs.
• Establish and build the Clinical QA department.
• Establish and grow a proficient and professional Clinical Quality Assurance team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensure that the team’s capabilities meet ALX’s future needs.

• 15+ years of experience in the biotech and/or pharmaceutical field in Clinical Development or Quality Operations
• 10+ years’ experience in development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies.