Senior Director, Clinical Quality

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $250k - $300k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 2%

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• 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 • Provide quality oversight of ongoing clinical trials and related activities, identify compliance risks, recommend mitigation plans, and ensure follow-through • Serve as the primary Quality contact for CROs, clinical vendors, investigator sites, laboratories, and other external partners • Lead qualification, ongoing assessment, and quality oversight of external clinical vendors • Develop and execute domestic and international audit plans covering CROs, clinical vendors, investigator sites, clinical databases, documents, processes, and internal systems • Assess, communicate, document, track, remediate, and close audit observations • Lead assessment and management of clinical quality events, including deviations, potential serious breaches, suspected scientific misconduct, investigations, root-cause analyses, CAPAs, and effectiveness checks • Partner with program teams to develop practical corrective and preventive actions • Review 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 • Establish and maintain inspection-readiness programs • Lead or host GCP regulatory inspections and provide Quality leadership during health authority inspections • Coordinate preparation, review, and submission of inspection responses and oversee 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 • Establish and monitor clinical quality metrics and trends and present quality events, risks, and performance indicators through governance forums • Escalate critical or systemic compliance issues and recommend immediate and long-term solutions to senior leadership • Apply practical, risk-based judgment to prioritize quality activities affecting patient safety, data integrity, compliance, and program success • Promote quality, accountability, collaboration, and continuous improvement • Stay current with global regulations, health authority expectations, industry trends, and best practices • Help curate a strong patient-focused department and company culture

🎯 Requirements

• 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

🏖️ Benefits

• Discretionary annual bonus may be available based on individual and Company performance • Equal opportunity employer • Full-time exempt position