Associate Director, CDM Programmer
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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). 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 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
- Bachelors 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 travel
Physical 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 weights
Work Environment:
- Remote: Home office; expected to travel to and work from the Companys 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
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 $184000 to $ 197000 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 Companys 401(k) 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 .
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals 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 members 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.
Required Experience:
Director
