Associate Director, CDM Programmer
Job
Avenzo Therapeutics, Inc
San Diego, CA (In Person)
$196,700 Salary, Full-Time
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Job Description
Job Title:
Associate Director, Clinical Data Management (CDM)Programmer 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). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The Company is headquartered in San Diego, California. Position Summary Reporting to the Senior Director, Data Management, the Associate Director, Clinical Data Management (CDM) Programmer will lead and oversee clinical data management activities across our clinical programs, ensuring the delivery of high-quality, compliant, and timely clinical trial data. This role serves as a hands-on leader and subject matter expert, partnering closely with Clinical Development, Biometrics, Medical, Regulatory, and external vendors to support decision-making and regulatory submissions. Essential Job Functions and Responsibilities Lead and oversee end-to-end clinical data management activities across assigned clinical programs, from study start-up through database lock and study close-out Define programming strategy, standards, and best practices for inspection-ready deliverables, including edit checks, derivations, custom functions, and automated data review tools Generate data listings, reconciliation outputs, and other programmed deliverables to support clinical data management and biostatistics. Direct the design, development, validation, and oversight of clinical data capture systems, ensuring data integrity and effective Contract Research Organization (CRO) oversight Oversee database build, User Acceptance Testing (UAT), data cleaning, medical coding, and database lock activities, ensuring timelines and quality expectations are met Serve as the clinical data management subject matter expert and study-level lead on cross-functional teams, partnering closely with Clinical Development, Biometrics, Clinical Operations, Medical, Regulatory, Quality, and Compliance Apply risk-based data management and quality oversight methodologies to proactively identify, assess, and mitigate data-related risks Manage CROs and external data vendors, including scope definition, performance monitoring, and issue escalation/resolution Ensure data management processes, documentation, and vendor deliverables comply with applicable regulations and standards (e.g., ICH-GCP, 21 CFR Part 11, GCDMP) Support inspection readiness and participate in audits and regulatory inspections as required Develop and maintain reusable programming assets (e.g., SAS macros) and automated outputs (listings/tables/visualizations) to support ongoing and ad hoc data review Provide technical leadership and guidance on clinical database structure, data standards, and downstream data use to internal teams and external vendors Ensure all programming outputs meet CDISC standards (e.g., SDTM/ADaM) and regulatory expectations Maintain study-level data management documentation in an audit-ready state and oversee quality-controlled filing within the electronic Trial Master File (eTMF) Proactively identify issues impacting study timelines, milestones, or data quality and implement effective mitigation strategies Contribute to the development, implementation, and continuous improvement of Clinical Data Management SOPs, standards, and best practices Support Clinical Operations, Biostatistics, and Data Management by providing data insights and solving complex technical and programming challenges Preferred Qualifications Bachelor s degree in Life Sciences or Computer Science required, or a related area degree preferred (e.g., MBA) with 10+ years of progressive Clinical Data Management experience in the life sciences industry or an equivalent combination of academic and industry experience Proficiency in SAS programming; experience with SQL, R, or Python is an advantage Strong understanding of clinical data management processes, including EDC design, data cleaning, query management, and database lock procedures Hands-on experience with CDISC standards (CDASH, SDTM) and data readiness for regulatory submissions Recognized for consistently delivering high-quality programming outputs, mentoring junior programmers, and improving CDM processes through automation and standardization Proficient with various data collection and Electronic Data Capture (EDC) systems Experience managing CROs and external vendors in a sponsor oversight mode Strong knowledge of clinical research, regulations and industry standards (e.g.FDA/ICH, ICH-GCP, 21 CFR
Part 11, GCDMP) 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 Promote knowledge sharing, documentation, and consistent application of programming standards. This 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 tasks Constant or frequent sitting, standing, or walking May 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 moderate Fast-paced, time sensitive environment with frequently changing priorities Handle multiple projects simultaneously Reasonable 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 $184,100 to $ 196,700 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 June 30, 2026. For more information about this posting, please contact careers@avenzotx.com . 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.Similar jobs in San Diego, CA
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