Director, Data Management

AVENZO THERAPEUTICS INC•CA - Corporate Office, CA

2d•$225,000 - $236,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in life sciences, data science, computer science or related field required, with 10+ years of progressive clinical data management experience in the life sciences industry or an equivalent combination of academic and industry experience
Proven experience leading outsourced Clinical Data Management activities and providing strategic oversight of CROs and third-party vendors across multiple clinical programs
Demonstrated success managing complex, global clinical trials and partnering effectively with cross-functional stakeholders in a matrixed environment
Experience building, leading, mentoring, and developing high-performing Data Management teams; prior people management experience preferred
Strong understanding of clinical development processes, with experience supporting Phase I through Phase III clinical trials and global development programs
Deep expertise in vendor governance, performance management, and risk-based oversight of outsourced data management models
Comprehensive knowledge of clinical trial data lifecycle management, including database design, data review, external data reconciliation, and database lock activities
Thorough understanding of applicable regulatory requirements, including FDA, EMA, ICH-GCP, and industry data standards such as CDISC
Demonstrated ability to identify and proactively mitigate operational, quality, and data integrity risks across multiple studies and programs
Strong strategic thinking, organizational, and problem-solving skills with the ability to effectively manage competing priorities in a fast-paced environment
Excellent leadership, communication, and stakeholder management skills, with the ability to engage and influence audiences at all levels of the organization
Proven ability to build alignment, drive decisions, and influence outcomes without direct authority across cross-functional teams and external partners
Experience leading process improvement, technology adoption, and operational excellence initiatives to enhance quality, scalability, and efficiency
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
Strong analytical and problem-solving abilities, with a strategic mindset

Responsibilities

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