Director of Clinical QA

About the Company

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging wholly owned technologies, the company has built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. The lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, Dren has launched multiple programs from its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies.

About the Role

This critical position will collaborate with internal clinical and nonclinical functional groups and external parties—including consultants, contract auditors, CRO/service provider personnel, and investigator sites—to promote a high level of quality and consistency across all Dren development programs using a risk-based approach. The Director of CQA will independently manage domestic and international risk-based audits of investigator sites, clinical vendors, study databases, partners, or collaborators as applicable, and support internal quality systems by creating, reviewing, and ensuring adherence to company policies, procedures, and GxP requirements.

Responsibilities

• Provide leadership and support for inspection readiness activities and initiatives, and for the preparation, conduct, and response periods of regulatory authority inspections.
• Maintain expert, up-to-date knowledge of applicable regulations governing clinical trials, ICH GCP guidelines, other GxP regulations, and industry guidance, and integrate this information into quality and clinical processes.
• Support the development and maintenance of CQA controlled documents and procedures that comply with ICH GCP standards and applicable regulations.
• Create and execute an annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, investigator sites, study databases, and the internal clinical team.
• Author and/or review procedures to support the Quality Management System, with emphasis on clinical quality processes, clinical operations, and clinical development functions.
• Collaborate with clinical functional groups (e.g., Clinical Operations, Data Management) to provide GCP and regulatory compliance support at the study execution level, including Clinical Study Execution Team (CSET) membership and participation.
• Perform review of clinical trial documents with a focus on compliance, regulatory requirements, and risk at the study and company levels. Documents include, but are not limited to: study protocol and amendments, informed consent forms, Investigator’s Brochure, annual reports (e.g., DSUR), clinical study reports, and other study-level documents (e.g., study plans, subject recruitment materials).
• Conduct gap analyses and risk assessments for critical study-level activities that may impact subject safety and/or the quality and reliability of data.
• Lead or support audits and investigations to evaluate non-compliance, perform root cause identification, and report results to Dren management, ensuring timely completion of comprehensive reports and communication of observations to auditees, impacted functional groups, and Dren management.
• Ensure audit corrective and preventive action (CAPA) plans adequately address audit observations and identified root causes, including effectiveness checks where appropriate.
• Escalate compliance issues to QA management and other relevant leadership in a timely manner.
• Develop and/or support GxP tasks or continuous improvement initiatives as needed.
• Manage the workflow of CQA consultant auditors and, as applicable, junior CQA staff.
• Build positive professional relationships to support learning, open communication, collaboration, and teamwork.

Requirements

• Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline.
• Minimum of 10 years of experience within the pharmaceutical industry with at least 8 years in a GCP or CQA quality role, with increasing levels of responsibility.
• Minimum of 5 years of experience leading or independently performing CQA audits (vendor qualification/routine/for-cause, investigator site, gap assessment, TMF, CSR, etc.), and audit CAPA management.

Core Competencies, Knowledge and Skills

• Experience with BIMO inspection, training, and preparing company and study sites for inspection readiness.
• Knowledge of computer system validation requirements in association with CQA audits.
• Effective communication skills (written and verbal).
• Ability to build and sustain positive relationships with colleagues, internal stakeholders, and external partners by being transparent, reliable, and delivering on commitments.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Ability to create innovative solutions to problems while integrating stakeholder input and feedback.
• Ability to manage multiple priorities and aggressive timelines.
• Highly responsible, self-motivated professional with enthusiasm and passion for the company’s mission.
• Proficiency with Microsoft and other computerized tools: MS Word, Outlook, Excel, PowerPoint, etc.
• Expert knowledge of ICH GCP guidelines and FDA regulations.

Pay

The base pay range for this position at commencement of employment is expected to be between $190,000 and $225,000 per year. Pay ranges are determined by role, level(s), and location. The range displayed reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.