Senior Director, Clinical Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Clinical Quality Assurance strategy and initiatives for Enliven’s clinical development programs, primarily focusing on GCP and GPvP compliance, with additional GLP support as necessary.

• Act as Enliven’s Clinical Quality Assurance subject matter expert, offering strategic and operational guidance to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other cross-functional teams.

• Create and implement quality and compliance strategies that are risk-based and appropriate for different phases.

• Ensure quality oversight of ongoing clinical trials and associated activities, identify compliance risks, propose mitigation plans, and guarantee follow-through.

• Serve as the main Quality contact for CROs, clinical vendors, investigator sites, laboratories, and other external partners.

• Lead the qualification, ongoing evaluation, and quality oversight of external clinical vendors.

• Design and execute audit plans for domestic and international settings, covering CROs, clinical vendors, investigator sites, clinical databases, documents, processes, and internal systems.

• Evaluate, communicate, document, track, remediate, and close audit observations.

• Manage and assess clinical quality events, including deviations, potential serious breaches, suspected scientific misconduct, investigations, root-cause analyses, CAPAs, and effectiveness checks.

• Collaborate with program teams to develop effective 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 the planning, execution, documentation, and closeout of clinical studies.

• Establish and maintain programs for inspection readiness.

• Lead or facilitate GCP regulatory inspections and offer Quality leadership during health authority inspections.

• Coordinate the preparation, review, and submission of responses to inspections, overseeing resulting commitments and follow-up actions.

• Develop, author, review, and maintain Clinical Quality Assurance procedures while providing Quality input into cross-functional GxP policies and procedures.

• Create and deliver training on GCP, GPvP, GLP, inspection readiness, and other relevant quality topics.

• Establish and monitor clinical quality metrics and trends, presenting quality events, risks, and performance indicators during governance forums.

• Escalate critical or systemic compliance issues and propose immediate and long-term solutions to senior leadership.

• Utilize practical, risk-based judgment to prioritize quality activities that impact patient safety, data integrity, compliance, and program success.

• Advocate for quality, accountability, collaboration, and continuous improvement.

• Remain informed about global regulations, health authority expectations, industry trends, and best practices.

• Contribute to fostering a strong patient-focused culture within the department and the company.

⛳️ Requirements

• Bachelor’s degree in a scientific, clinical, pharmaceutical, or related field, accompanied by 12+ years of relevant experience in the pharmaceutical or biotechnology industry; an advanced degree with equivalent relevant experience will also be considered.

• Substantial experience leading Clinical Quality Assurance activities that support clinical-stage development programs.

• Deep understanding of GCP and relevant FDA, EMA, ICH, MHRA, and other global regulations and guidance related to clinical development.

• Strong working knowledge of GPvP requirements; experience with GLP and/or GCLP activities is preferred.

• Proven ability to develop and execute phase-appropriate, risk-based clinical quality and compliance strategies.

• Experience in planning, conducting, and overseeing audits of CROs, clinical vendors, investigator sites, clinical systems, databases, processes, and essential documents.

• Demonstrated success in leading investigations, serious-breach assessments, root-cause analyses, CAPAs, effectiveness checks, and other clinical quality events to resolution.

• Direct experience in supporting regulatory authority inspections, including preparation, hosting, response development, and follow-up activities.

• Experience providing Quality review of clinical, safety, and regulatory documents, as well as supporting regulatory submissions.

• Proven track record of overseeing CROs and other external partners in a highly outsourced clinical development setting.

• Ability to apply strong scientific and quality judgment while balancing compliance needs, patient safety, data integrity, program risk, and business priorities.

• Solution-oriented and pragmatic, capable of addressing emerging challenges without introducing unnecessary processes or complexity.

• Strong strategic thinking, project management, and decision-making skills, with the ability to juggle multiple programs and competing priorities.

• Demonstrated ability to influence cross-functional teams and external partners, cultivate effective relationships, and promote a collaborative quality culture.

• Excellent written, verbal, and presentation skills, including the capability to clearly communicate complex quality and compliance issues to senior leadership.

• Comfortable working autonomously and hands-on in a dynamic, fast-paced, and growing biotechnology company.

• Experience in oncology and support for mid-to-late-stage clinical programs is preferred.

• Familiarity with Veeva, SharePoint, and Microsoft Office applications is preferred.

• Willingness to travel around 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.