Director of Clinical QA

Careers 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 our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our 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, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, 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. For more information, please visit our website at www.drenbio.com. Function: Quality Level: Director Location: San Carlos, CA (Remote candidates may be considered) Reporting Manager: VP of Quality About the Opportunity: 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. This includes a risk-based approach to Quality Management for all Dren programs. Additionally, this position will independently manage domestic and international risk-based audits of Investigator Sites, clinical vendors, study databases, partners or collaborators (as applicable). The Director of CQA will also support internal Dren quality systems with the creation, review, and adherence to company policies, and procedures and adhering to GxP requirements. Role and 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 on applicable regulations that govern the conduct of clinical trials, ICH GCP guidelines and other GxP regulations and industry guidance and ensure the information is integrated 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 annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, Investigator sites, study databases, and internal clinical team. Author and/or review procedures to support the Quality Management System, with an emphasis on clinical quality processes, clinical operations and clinical development functions. Collaborate with clinical functional groups (e.g., Clinical Operations, Data Management, etc.) to provide GCP and regulatory compliance support at the study execution level. This includes Clinical Study Execution Team (CSET) membership and participation. Perform review of clinical trial documents with a focus on compliance, regulatory requirements, and risk (study and company levels). The study documents include but are not limited to: Study Protocol and amendments, ICFs, Investigator’s Brochure, Annual Reports (e.g., DSUR), CSRs,...