4D Molecular Therapeutics

QA Engineer

• Provide QA oversight and support business and CSV activities throughout the lifecycle of GxP computerized systems.
• Review and approve CSV deliverables, IT change management requests, and quality records (e.g., NCRs CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards.
• Review plans and provide day-to-day QA guidance and support to initial validation, steady state activities and controlled change-related initiatives of GxP systems.
• Serve as a subject matter expert (SME) in CSV requirements, data integrity controls, and related regulatory requirements / standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH Guidelines.
• Develop and/or refine QA and CSV-related procedures and templates.
• Support audits for qualification and requalification of IT vendors.
• Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
• Support inspection readiness initiatives, audits and regulatory inspections.
• Other duties as assigned.

Associate Director, QA Computer System Validation

Director

• Lead and manage Data Solutions & Optimization, including clinical programming, EDC programming, data analytics, and visualization functions.
• Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
• Drive the development of technical initiatives, including EDC integration, participate in specification review &/or development of Spotfire visualizations, data currency and cleanliness metrics and visualizations, and other solutions in partnership with IT System Owner & other key stakeholders.
• Ensure the EDC platform is a qualified and validated system and manage the impact analysis of system updates, ensuring ongoing system optimization, risk mitigation, and cross-functional awareness.
• Lead data standards initiatives including data cleaning and reporting tools and standard CRFs and edit checks, ensuring alignment with current CDISC SDTM standards.
• Drive process improvements, workflow optimizations, and the development of new SOPs to enhance operational efficiency.
• Provide strategic oversight and support of high-priority projects, including database builds, freezes, and locks, user access management for data systems, and evaluation of system updates.
• Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
• Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
• Collaborate with other departments (i.e., IT, Clinical Operations, Clinical Science, etc.) to align data strategies with broader organizational goals and objectives.
• Function as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.

Director, Data Solutions – Optimization

Manager

• Provide technical leadership for statistical programming activities for a given clinical development program.
• Accountable for the accuracy, quality, and timeliness of programming deliverables for clinical trial reporting, integrated safety/efficacy analyses, and global regulatory submissions.
• Drive the development and maintenance of programming standards and tools, ensuring compliance with CDISC standards, ICH GCP, and applicable regulatory requirements.
• Collaborate closely with cross‑functional teams and external vendors.

Senior Manager, Statistical Programming

• Provide statistical programming leadership for an assigned indication that may consist of multiple clinical trials
• Work closely with biostatisticians to review the SAP, and responsible in the development of data/analysis program specification based on the SAP
• Maintain complete and auditable programming documentations for analysis of clinical trials
• Contribute to the development, documentation and maintenance of reusable programming code library
• Collaborate with IT to set-up/maintain the statistical computing infrastructure (e.g., SAS server)
• May act as a biostatistician on small-scale projects
• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials
• Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables
• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
• Contribute to the development of functional-level standards, SOPs, and work instructions and templates
• Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Director, Statistical Programming

• Manage end‑to‑end Data Management activities for one or more clinical studies with moderate guidance from line manager.
• Oversee daily study‑level data management operations, ensuring compliance to timelines, quality standards, and SOPs.
• Support vendor oversight activities, including reviewing timelines, deliverables, and quality metrics.
• Contribute to risk identification and mitigation strategies for data‑related issues.
• Review study protocols to ensure appropriate data capture elements and eCRF design.
• Support the development of eCRF specifications and contribute to review of data requirements.
• Assist in coordinating EDC system design, testing, and UAT, ensuring adherence to company standards.
• Contribute and/or author Data Management Plans, Data Transfer Plans, and other study‑related documents.
• Support review of clinical monitoring plans, SAPs, and vendor specifications.
• Monitor data quality and cleaning activities, including management of data listings and reconciliation efforts.
• Partner with CROs and external vendors to ensure timely and high‑quality data deliverables.
• Participate in study team meetings, providing updates on Data Management metrics and timelines.
• Escalate issues appropriately to line manager, data management leadership or other functional leads.
• Oversee reconciliation activities (e.g., header data, SAE reconciliation) performed by CROs.
• Support database upgrades and migrations, including contribution to UAT.
• Participate in database snapshot, lock, and freeze activities.
• Provide day‑to‑day guidance and mentorship to Data Managers.
• Deliver training to internal and external team members on EDC systems or eCRF completion guidelines as needed.
• Maintain Data Management documentation and eTMF files.
• Other duties assigned.

Associate Director, QA Computer System Validation

Director, Data Solutions – Optimization

Senior Manager, Statistical Programming

Director, Statistical Programming

Senior Manager, Data Management