Director, Data Management

Avenzo Therapeutics; California (MO); Hybrid; USD 225,000 - 236,000; Full time

Job summary

Avenzo Therapeutics, Inc. seeks a Director of Data Management in San Diego or remote in the U.S. to lead data management operations across study programs, overseeing CROs and vendors, ensuring data quality and regulatory compliance.

Reporting to the Senior Director, this role drives data strategies, risk management, and collaboration with Clinical Operations, Biostatistics, Medical Writing, Regulatory Affairs, and Quality to support development objectives.

Qualifications

• Bachelor’s degree or higher in life sciences, data science, computer science or related field.
• 10+ years of progressive clinical data management experience.
• Experience leading outsourced CDM activities and CRO/vendor oversight.
• Strong cross-functional collaboration and stakeholder management across global programs.
• Deep knowledge of regulatory requirements (FDA/EMA/ICH-GCP) and CDISC standards.

Responsibilities

• Provide leadership and oversight of outsourced Clinical Data Management activities across development programs.
• Serve as a Data Management representative on cross-functional study teams and provide strategic input.
• Oversee data management CROs and third-party vendors with performance management and risk mitigation.
• Ensure timely execution of database build, data review, reconciliation, queries, and database lock.

Skills

Leadership

Vendor governance

Data management

Clinical trials

Cross-functional collaboration

Regulatory knowledge

People management

Project management

CDISC/ICH-GCP

Global development programs

Education

Bachelor’s degree in life sciences, data science, computer science or related field

Tools

EDC systems

Job description

Job Title:

Director, Data Management

Location:

San Diego or Remote U.S.

Job Type:

Full-Time

Who We Are

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.

Position Summary

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.

Essential Job Functions And 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

Preferred Qualifications

• 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
• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel

Physical Demands

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights

Work Environment

• Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based: On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Salary Range

The salary range for this position is $225,000 to $236,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

Equal Employment Opportunity

Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision‑making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws.

Notice to Search Firms/Third Party Agencies

Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.