Director, Data Management

Job Title:

Director, Data Management

San Diego or Remote U.S.

Full-Time

Avenzo Therapeutics, Inc. ("Avenzo" or "Company") is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer.

The Company is headquartered in San Diego, California.

Reporting to the Senior Director, Data Management, the Director, Data Management will be responsible for performing or overseeing vendors to perform Data Management operational end-to-end activities and participate as an active member in a cross-function study team to plan, lead, and execute tasks required for assigned clinical studies across all phases. The director will oversee and lead data management project activities, coordinate interdepartmental and client communication, and help resolve administrative and site issues.

• Provide leadership and oversight of outsourced Clinical Data Management activities across Avenzo's clinical development programs, ensuring delivery of high-quality, reliable, and inspection-ready clinical data
• Serve as a Data Management representative on cross-functional study teams and provide strategic input throughout study planning, execution, analysis, and reporting
• Oversee Data Management CROs and third-party vendors, including performance management, issue escalation, risk mitigation, and delivery of study milestones
• Ensure timely execution of database build, data review, external data reconciliation, query management, and database lock activities
• Establish and maintain data quality standards, oversight plans, metrics, and processes to ensure data integrity and regulatory compliance across studies
• Identify, assess, and proactively manage data-related risks that may impact study timelines, data quality, or regulatory deliverables
• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Pharmacology, Medical Writing, Regulatory Affairs, and Quality to support development objectives
• Ensure availability of high-quality clinical data to support interim analyses, DSMB reviews, regulatory submissions, and final study reporting
• Lead data review and cleaning strategies and ensure effective oversight of vendor deliverables and issue resolution
• Support inspection readiness activities, including maintenance of appropriate documentation, vendor oversight records, and data management deliverables
• Ensure compliance with ICH-GCP, CDISC standards, internal SOPs, and applicable regulatory requirements
• Oversee the implementation and effective use of EDC and related clinical data systems and support evaluation of new technologies and process improvements
• Drive continuous improvement initiatives to enhance efficiency, quality, scalability, and consistency of Data Management processes.
• Communicate study status, key metrics, risks, and mitigation plans to cross-functional teams, governance committees, and senior leadership
• Build, mentor, and develop Data Management staff and contribute to talent acquisition, onboarding, succession planning, and employee development
• Foster a culture of collaboration, accountability, quality, and continuous improvement across the Data Management function

• Bachelor’s degree in life sciences, data science, computer science or related field required, with 10+ years of progressive clinical data…