Director, Clinical Quality

VIKING THERAPEUTICS INC; San Diego (CA); Sur place; USD 180 000 - 280 000; Plein temps

Résumé du poste

Viking Therapeutics Inc in San Diego seeks a Director, Clinical Quality to lead the Clinical QA function across early- to late-stage programs, building scalable GCP systems and governance that support reliable data and participant protection.

You will partner with Clinical Development, Operations, Biostatistics, Regulatory Affairs and CROs, owning inspection readiness, risk management, CAPA execution, and continuous quality improvements toward regulatory submissions.

Responsabilités

• Lead the Clinical QA function and develop and execute a Clinical QA strategy aligned with corporate, clinical development, and program objectives.
• Ensure Clinical QA activities support compliance with global GCP regulations, guidance, internal procedures, and quality standards.
• Serve as the Clinical QA representative on clinical program and study teams and provide independent, risk-based quality guidance throughout the clinical development lifecycle.
• Develop, implement, and continuously improve phase-appropriate clinical quality systems, SOPs, processes, governance structures, and training programs.
• Establish and maintain risk-based quality oversight of CROs and other GCP service providers, including vendor qualification, quality governance, performance monitoring, issue escalation, CAPA effectiveness, and periodic quality review.
• Partner with Clinical Operations and study teams to implement clinical quality risk management approaches, including identification of critical-to-quality factors, proactive risk identification, monitoring of quality signals, and escalation and mitigation of significant risks.
• Review and provide independent QA input on study-specific documentation and quality-critical clinical processes, as appropriate.
• Provide Clinical QA oversight of investigator site, CRO, laboratory, and other service-provider compliance and support timely escalation and remediation of significant GCP issues.
• Provide compliance direction for investigations of significant clinical quality issues involving GCP, subject protection, data integrity, product handling or administration, and safety-related processes.
• Lead GCP inspection readiness and inspection management activities, including readiness assessments, mock inspections and interviews, inspection preparation, response coordination, and CAPA follow-up for FDA BIMO and other applicable Health Authority inspections.

Description du poste

Description

The Director, Clinical Quality will lead the Clinical Quality Assurance function and provide strategic leadership and hands‑on quality oversight across early- through late-stage clinical development programs. The role is responsible for developing, implementing, and maintaining phase‑appropriate, risk‑based GCP quality systems, processes, and governance that support reliable clinical data, protection of clinical trial participants, and advancement of clinical programs toward regulatory submissions and inspections.

The Director will partner closely with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other cross‑functional stakeholders and will provide independent Quality oversight of contract research organizations (CROs), clinical sites, laboratories, and other GCP service providers. The role will lead GCP inspection readiness, clinical quality risk management, audit strategy, significant quality issue management, and continuous improvement activities supporting late‑stage development and NDA/BIMO readiness.

The successful candidate will be a pragmatic, collaborative Clinical Quality leader who can establish scalable systems while remaining actively engaged in day‑to‑day clinical quality activities. Strong knowledge of global GCP requirements, sponsor oversight, clinical quality systems, computerized systems, data integrity, and Health Authority inspection expectations is essential.

Essentials Duties and Responsibilities

The main responsibilities of this role include:

• Lead the Clinical Quality Assurance function and develop and execute a Clinical QA strategy aligned with corporate, clinical development, and program objectives.
• Ensure Clinical QA activities support compliance with applicable global GCP regulations, guidance, internal procedures, and quality standards.
• Serve as the Clinical QA representative on clinical program and study teams and provide independent, risk‑based quality guidance throughout the clinical development lifecycle.
• Develop, implement, and continuously improve phase‑appropriate clinical quality systems, SOPs, processes, governance structures, and training programs.
• Establish and maintain risk‑based quality oversight of CROs and other GCP service providers, including vendor qualification, quality governance, performance monitoring, issue escalation, CAPA effectiveness, and periodic quality review.
• Partner with Clinical Operations and study teams to implement clinical quality risk management approaches, including identification of critical‑to‑quality factors, proactive risk identification, monitoring of quality signals, and escalation and mitigation of significant risks.
• Review and provide independent QA input on study‑specific documentation and quality‑critical clinical processes, as appropriate.
• Provide Clinical QA oversight of investigator site, CRO, laboratory, and other service‑provider compliance and support timely escalation and remediation of significant GCP issues.
• Provide compliance direction for investigations of significant clinical quality issues involving GCP, subject protection, data integrity, product handling or administration, and safety‑related processes. Support root‑cause analysis, CAPA development, effectiveness assessment, and appropriate escalation.
• Assess significant GCP compliance issues for potential regulatory reporting obligations and partner with Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Quality leadership to determine appropriate escalation and reporting.
• Identify, communicate, and escalation clinical compliance risks and recommend pragmatic mitigation plans to Clinical Development and Quality leadership.
• Develop and execute a risk‑based audit strategy covering CROs and other vendors, clinical investigator sites, internal clinical processes, and other GCP‑relevant activities.
• Assess audit findings for potential impact on clinical trial participants, data integrity, regulatory compliance, and business operations and ensure timely CAPA development, follow‑up, and closure.
• Provide independent Quality oversight of TMF/eTMF health and inspection readiness, including governance, quality indicators, significant documentation gaps, and remediation activities.
• Provide Clinical QA oversight of GCP‑relevant computerized systems, data integrity controls, and validation activities in partnership with system owners and functional stakeholders.
• Lead GCP inspection readiness and inspection management activities, including readiness assessments, mock inspections and interviews, inspection preparation, response coordination, and CAPA follow‑up for FDA BIMO and other applicable Health Authority inspections.
• Provide Quality oversight and support for CRO, investigator site, and service‑provider regulatory inspections, as appropriate.
• Develop meaningful clinical quality metrics, trend analyses, and management reporting to identify systemic risks and drive continuous improvement.
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