Director, Clinical Quality

Viking Therapeutics, Inc.•San Diego, CA

7d•$195,000 - $215,000

About The Position

The Director, Clinical Quality leads the Clinical Quality Assurance function and provides strategic leadership and hands-on quality oversight across early- through late-stage clinical development. The role develops, implements, and maintains phase-appropriate, risk-based GCP quality systems, processes, and governance to support reliable clinical data, protect trial participants, and advance clinical programs toward regulatory submissions and inspections. The Director partners with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other stakeholders. The role provides independent Quality oversight of CROs, clinical sites, laboratories, and other GCP service providers, and leads GCP inspection readiness, clinical quality risk management, audit strategy, significant quality issue management, and continuous improvement supporting late-stage development and NDA/BIMO readiness. The successful candidate is a pragmatic, collaborative Clinical Quality leader who can establish scalable systems while remaining engaged in day-to-day clinical quality activities. Essential knowledge includes global GCP requirements, sponsor oversight, clinical quality systems, computerized systems, data integrity, and Health Authority inspection expectations.

Requirements

Bachelor's or Master's degree in Life Sciences or a related discipline.
12+ years of progressive Clinical Quality Assurance experience in the pharmaceutical or biotechnology industry, including significant experience supporting late-stage clinical development.
Demonstrated leadership experience, including leading cross-functional quality initiatives and/or Clinical QA personnel.
Demonstrated experience supporting sponsor GCP inspection readiness and FDA BIMO inspections.
Expert working knowledge of applicable GCP regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, and 312; ICH E6(R3); ICH E8; and applicable GCLP principles.
Strong experience with CRO and vendor oversight, clinical investigator/site compliance, vendor qualification, vendor audits, internal audits, and clinical quality issue management.
Strong working knowledge of clinical quality risk management, TMF/eTMF quality and inspection readiness, computerized system validation, and data integrity expectations in the GCP environment.
Experience developing, implementing, and improving Clinical Quality systems, SOPs, governance processes, metrics, and training programs.
Experience with significant quality events, root-cause analysis, CAPA development, effectiveness checks, risk assessment, and compliance escalation.
Ability to understand business and clinical development objectives and translate them into fit-for-purpose Quality priorities and risk-based oversight.
Demonstrated ability to establish a vision for Clinical Quality as programs progress from early development through late-stage development and commercialization readiness.
Demonstrated success working with and overseeing external partners in an outsourced clinical development model.
Ability to work independently and effectively in a collaborative, fast-paced, multidisciplinary environment with internal and external stakeholders.
Demonstrated initiative, ownership, sound judgment, problem solving, analytical thinking, and strategic decision making.
Results-driven and collaborative leadership style, strong attention to detail, and ability to manage multiple competing priorities.
Excellent written and verbal communication skills, including the ability to communicate quality risks, recommendations, and expectations clearly to senior leaders and external partners.
Ability to lead and develop experienced professionals while promoting accountability, collaboration, and delivery of results.

Nice To Haves

Familiarity with international clinical trial requirements, including EU CTR and GDPR.
Experience with electronic quality management systems (eQMS), such as Veeva Quality/Veeva Vault.
Late-stage clinical development, NDA submission, and commercialization-readiness experience.

Responsibilities

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.
Represent Clinical QA on clinical program and study teams, providing 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, governance, performance monitoring, issue escalation, CAPA effectiveness, and periodic quality review.
Partner with Clinical Operations and study teams on clinical quality risk management, including critical-to-quality factors, proactive risk identification, monitoring quality signals, and escalation and mitigation of significant risks.
Review study-specific documentation and quality-critical clinical processes and provide independent QA input as appropriate.
Oversee GCP compliance at investigator sites, CROs, laboratories, and other service providers, and support timely escalation and remediation of significant 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 escalation.
Assess significant GCP compliance issues for potential regulatory reporting obligations and partner with relevant functions and Quality leadership on escalation and reporting.
Identify, communicate, and escalate 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, investigator sites, internal clinical processes, and other GCP-relevant activities.
Assess audit findings for potential impact on 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, documentation gaps, and remediation.
Oversee GCP-relevant computerized systems, data integrity controls, and validation activities in partnership with system owners and functional stakeholders.
Lead GCP inspection readiness and management, including readiness assessments, mock inspections and interviews, 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 clinical quality metrics, trend analyses, and management reporting to identify systemic risks and drive continuous improvement.
Partner with cross-functional stakeholders to develop and mature GCP and clinical quality training programs.
Lead, mentor, and develop Clinical QA personnel and scale Clinical QA capabilities to support the clinical development portfolio.
Adjust priorities and quality strategies in response to evolving program needs while maintaining appropriate compliance and quality standards in a dynamic, fast-paced environment.
Perform other duties as assigned.