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 oncology 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) and Good Pharmacovigilance Practice (GPvP) 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 and GPvP 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, GPvP, 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

• Bachelor’s degree in a scientific, clinical, pharmaceutical, or related discipline with 12+ years of relevant pharmaceutical or biotechnology industry experience; an advanced degree and equivalent relevant experience will also be considered
• Significant experience leading Clinical Quality Assurance activities supporting clinical-stage development programs
• Extensive knowledge of GCP and applicable FDA, EMA, ICH, MHRA, and other global regulations and guidance governing clinical development
• Strong working knowledge of GPvP requirements; experience supporting GLP and/or GCLP activities is preferred
• Demonstrated experience developing and implementing phase-appropriate, risk-based clinical quality and compliance strategies
• Experience planning, conducting, and overseeing audits of CROs, clinical vendors, investigator sites, clinical systems, databases, processes, and essential documents
• Proven experience leading investigations, serious-breach assessments, root-cause analyses, CAPAs, effectiveness checks, and other clinical quality events through resolution
• Direct experience supporting regulatory authority inspections, including inspection preparation, hosting, response development, and follow-up activities
• Experience providing Quality review of clinical, safety, and regulatory documents and supporting regulatory submissions
• Demonstrated success overseeing CROs and other external partners in a highly outsourced clinical development environment
• Ability to apply strong scientific and quality judgment while balancing compliance requirements, patient safety, data integrity, program risk, and business priorities
• Solution-oriented and pragmatic, with the ability to address emerging challenges without creating unnecessary process or complexity
• Strong strategic thinking, project management, and decision-making skills, with the ability to manage multiple programs and competing priorities
• Demonstrated ability to influence cross-functional teams and external partners, build effective relationships, and promote a collaborative quality culture
• Excellent written, verbal, and presentation skills, including the ability to communicate complex quality and compliance issues clearly to senior leadership
• Comfortable working independently and operating hands-on in a fast-paced, agile, and growing biotechnology company
• Experience in oncology and supporting mid-to-late-stage clinical programs is preferred
• Experience with Veeva, SharePoint, and Microsoft Office applications is preferred
• Ability to travel approximately 25%, including occasional international travel

The expected salary range for this position is: $250k - $300k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.