Director, Clinical Quality

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 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, 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.
- Partner with cross-functional stakeholders to develop and mature GCP and clinical quality training programs.
- Lead, mentor, and develop Clinical QA personnel and appropriately scale Clinical QA capabilities to support the clinical development portfolio.
- Operate effectively in a dynamic, fast-paced environment by adjusting priorities and quality strategies in response to evolving program needs while maintaining appropriate compliance and quality standards.
- Other duties as assigned.

Requirements

Education and Experience 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; experience with other Health Authority inspections is a plus.

Knowledge and Skills Requirements

- 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. Familiarity with international clinical trial requirements, including EU CTR and GDPR, is a plus.
- 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 with strong attention to detail and the 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.
- Experience with electronic quality management systems (eQMS), such as Veeva Quality/Veeva Vault, is preferred.
- Late-stage clinical development, NDA submission, and commercialization-readiness experience is strongly preferred.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Salary Description

$195,000.00 - $215,000.00 annual salary

#LI-DNI

Salary Description
$195,000.00 - $215,000.00 annual salary