Senior Director, Clinical Quality

Position: Senior Director, Quality Assurance

Department: Quality

Location: Remote USA

Status: Full-time Exempt

About Us

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.

Role Summary

We are seeking an experienced Senior Director, Quality Assurance to lead Clinical Quality Assurance activities across Enliven’s development programs. This individual will provide strategic and hands-on leadership for Good Clinical Practice (GCP) quality activities, with support for Good Laboratory Practice (GLP) programs as needed.

The Senior Director will serve as Enliven’s primary Clinical Quality Assurance subject matter expert and a strategic partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other cross-functional teams. This role will establish phase-appropriate, risk-based quality strategies; oversee clinical vendors, investigator sites, audits, and quality events; and ensure Enliven, its partners, and its clinical programs remain compliant and inspection-ready.

The successful candidate will be a hands-on and pragmatic quality leader who can apply sound judgment, identify and mitigate meaningful risks, and help teams solve problems while maintaining the highest standards for patient safety, data integrity, and regulatory compliance.

The role reports to the Vice President, Regulatory, Quality and Safety.

Core Responsibilities

• Lead Clinical Quality Assurance strategy and activities across Enliven’s clinical development programs, with primary responsibility for GCP compliance and additional GLP support as needed
• Serve as Enliven’s Clinical Quality Assurance subject matter expert and provide strategic and operational guidance to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other cross-functional teams
• Develop and implement phase-appropriate, risk-based quality and compliance strategies that support clinical program objectives, patient safety, data integrity, and regulatory requirements
• Provide quality oversight of ongoing clinical trials and related activities, proactively identifying compliance risks, recommending mitigation plans, and ensuring appropriate follow-through
• Serve as the primary Quality contact for CROs, clinical vendors, investigator sites, laboratories, and other external partners supporting Enliven’s clinical programs
• Lead the qualification, ongoing assessment, and quality oversight of external clinical vendors, including review and approval of quality agreements and participation in vendor governance and performance discussions
• Develop and execute domestic and international audit plans covering CROs, clinical vendors, investigator sites, clinical databases, documents, processes, and internal systems
• Ensure audit observations are appropriately assessed, communicated, documented, tracked, remediated, and closed
• Lead the assessment and management of clinical quality events, including deviations, potential serious breaches, suspected scientific misconduct, investigations, root-cause analyses, corrective and preventive actions, and effectiveness checks
• Partner with program teams to develop practical and sustainable corrective and preventive actions that address root causes and reduce recurrence
• Review key clinical, safety, quality, and regulatory documents, including protocols, informed consent forms, Investigator’s Brochures, Clinical Study Reports, Development Safety Update Reports, INDs, NDAs, and other regulatory submissions
• Provide quality input into clinical study planning, execution, documentation, and closeout activities
• Establish and maintain inspection-readiness programs across Enliven, its CROs, clinical vendors, and investigator sites
• Lead or host GCP regulatory inspections and provide Quality leadership during health authority inspections of Enliven, investigator sites, and external partners
• Coordinate the preparation, review, and timely submission of inspection responses and oversee completion of resulting commitments and follow-up actions
• Develop, author, review, and maintain Clinical Quality Assurance procedures and provide Quality input into cross-functional GxP policies and procedures
• Develop and deliver GCP, GLP, inspection-readiness, and other relevant quality training to internal teams and external partners as appropriate
• Establish and monitor meaningful clinical quality metrics and trends and present quality events, risks, and performance indicators through Quality Management Review and other governance forums
• Escalate critical or systemic compliance issues and recommend appropriate immediate and long-term solutions to senior leadership
• Apply practical, risk-based judgment to prioritize the quality activities that have the greatest impact on patient safety, data integrity, compliance, and program success
• Promote a strong culture of quality, accountability, collaboration, and continuous improvement throughout the organization
• Stay current with evolving global regulations, health authority expectations, industry trends, and best practices relevant to clinical research and development
• Help curate a strong patient-focused department and company culture