Associate Director, CDM Programmer

AVENZO THERAPEUTICS INC•San Diego, CA

1d•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). 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. 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.

Requirements

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.

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