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Director, Data Management

$225k - $236k

Avenzo Therapeutics

Director, Data ManagementReporting 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.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.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 dataServe as a Data Management representative on cross-functional study teams and provide strategic input throughout study planning, execution, analysis, and reportingOversee Data Management CROs and third-party vendors, including performance management, issue escalation, risk mitigation, and delivery of study milestonesEnsure timely execution of database build, data review, external data reconciliation, query management, and database lock activitiesEstablish and maintain data quality standards, oversight plans, metrics, and processes to ensure data integrity and regulatory compliance across studiesIdentify, assess, and proactively manage data-related risks that may impact study timelines, data quality, or regulatory deliverablesCollaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Pharmacology, Medical Writing, Regulatory Affairs, and Quality to support development objectivesEnsure availability of high-quality clinical data to support interim analyses, DSMB reviews, regulatory submissions, and final study reportingLead data review and cleaning strategies and ensure effective oversight of vendor deliverables and issue resolutionSupport inspection readiness activities, including maintenance of appropriate documentation, vendor oversight records, and data management deliverablesEnsure compliance with ICH-GCP, CDISC standards, internal SOPs, and applicable regulatory requirementsOversee the implementation and effective use of EDC and related clinical data systems and support evaluation of new technologies and process improvementsDrive 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 leadershipBuild, mentor, and develop Data Management staff and contribute to talent acquisition, onboarding, succession planning, and employee developmentFoster a culture of collaboration, accountability, quality, and continuous improvement across the Data Management functionPreferred 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 experienceProven experience leading outsourced Clinical Data Management activities and providing strategic oversight of CROs and third-party vendors across multiple clinical programsDemonstrated success managing complex, global clinical trials and partnering effectively with cross-functional stakeholders in a matrixed environmentExperience building, leading, mentoring, and developing high-performing Data Management teams; prior people management experience preferredStrong understanding of clinical development processes, with experience supporting Phase I through Phase III clinical trials and global development programsDeep expertise in vendor governance, performance management, and risk-based oversight of outsourced data management modelsComprehensive knowledge of clinical trial data lifecycle management, including database design, data review, external data reconciliation, and database lock activitiesThorough understanding of applicable regulatory requirements, including FDA, EMA, ICH-GCP, and industry data standards such as CDISCDemonstrated ability to identify and proactively mitigate operational, quality, and data integrity risks across multiple studies and programsStrong strategic thinking, organizational, and problem-solving skills with the ability to effectively manage competing priorities in a fast-paced environmentExcellent leadership, communication, and stakeholder management skills, with the ability to engage and influence audiences at all levels of the organizationProven ability to build alignment, drive decisions, and influence outcomes without direct authority across cross-functional teams and external partnersExperience leading process improvement, technology adoption, and operational excellence initiatives to enhance quality, scalability, and efficiencyExcellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholdersStrong analytical and problem-solving abilities, with a strategic mindsetThis position requires periodic/regular travel, including up to 10% of work time, which may include overnight travelPhysical Demands and Work Environment:Physical Demands:Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasksConstant or frequent sitting, standing, or walkingMay lift and/or move objects of various weightsWork Environment:Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to timeSan Diego-based: On-site requirement (Monday through Thursday)Noise level in the work environment is usually moderateFast-paced, time sensitive environment with frequently changing prioritiesHandle multiple projects simultaneouslyReasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.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.The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.Applications for this position are anticipated to close on September 30, 2026. For more information about this posting, please contact View email address on click.appcast.io 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 Avenzo Therapeutics

Vacancy posted 5 days ago
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