4D Molecular Therapeutics

Clinical Research

• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
• Collect, track and conduct initial review for completeness of site regulatory documents and/or TMF filing
• Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
• Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with study conduct, and/or close-out activities
• Assist with tracking of clinical trial progress including status update reports, as requested
• Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
• Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
• May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
• Other duties as may be assigned

Associate Clinical Trial Manager – Temporary

Director

• Provides strategic statistical input to and oversees all statistical aspects of assigned programs;
• Drives cross-functional collaboration and decision making for program(s);
• Oversees the performance of Contract Research Organizations (CROs);
• Develop and mentor other statisticians.
• Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans.
• Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
• Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.

Director, Biostatistics

• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
• Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
• Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
• Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
• Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
• Assist with the development of site tools and clinical trial start-up activities
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
• Assist in tracking of trial IP and development of Pharmacy Manuals
• Participate in study vendor set up and specification process, as appropriate
• Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
• Assist with tracking of clinical trial progress including status update reports, as requested
• Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
• Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
• Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
• May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
• Willing to travel as business needs demand (<5% anticipated)
• Other duties as may be assigned

Associate Clinical Trial Manager

• Responsible for projecting, planning, executing, and overseeing all supply chain activities related to clinical trial materials.
• Manage the procurement, production, packaging, labeling, distribution, and inventory of clinical trial materials.
• Ensure clinical supplies are delivered on time, within budget, and in compliance with regulatory requirements.
• Follow-up communication with various departments and stakeholders.

Associate Director, Clinical Supply

Clinical Operations

• Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines
• Provide operational leadership to the direction, planning, execution and interpretation of clinical trials
• Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups
• Collaborate with Finance/Business Operations on annual budget planning and quarterly budget reviews
• Ensure that each clinical trial is always inspection ready

Associate Director, Clinical Operations

• Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials.
• Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials, and study updates.
• Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct.
• Prepare and communicate clear overviews of trial results.
• Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions to ensure resolution.
• Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives.
• Act as a recognized clinical expert for assigned programs.
• Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for the Executive Team, Board of Directors, Advisory Boards, and the Data and Safety Monitoring Committees [DSMC])
• Together with the Therapeutic Area Head for Lung, serve as a point of contact for the clinical operations personnel, clinical trial sites, and CROs for clinical science questions.
• Maintains knowledge of ICH-GCP and FDA IND, and external regulations and procedures.
• Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and others.
• Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions.
• Ability to travel, approximately 5%.

Director, Clinical Science

Supply Chain

• Define and execute the global supply strategy across early- and late-stage programs, including Phase 1–3, commercial launch, and post-approval commitments
• Serve as the enterprise leader for clinical trial supply governance, risk management, and scenario planning
• Build a commercial-ready supply chain organization to support product launch
• Provide senior-level input into development timelines, enrollment strategies, and global expansion plans based on supply feasibility
• Anticipate and proactively mitigate supply risks.
• Drive BLA-enabling supply chain activities.
• Oversee end-to-end clinical supply execution.

Vice President, Supply Chain

• Support the Company's clinical trial activities
• Manage day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities
• Serve as the primary contact for managing protocol execution, including oversight of the CRO, study service providers, and consultants
• Lead cross-functional study execution team
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical trial documentation
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately
• Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation
• Manage clinical trial budgets, providing ongoing financial reporting and projections
• Perform and manage data review process on an ongoing basis
• Perform site visits as needed.

Clinical Trial Manager

IT Support

• Own and operate clinical systems as system owner, including access control, configuration, validation, and lifecycle management.
• Ensure systems remain compliant with GxP regulations and internal SOPs, preserving data integrity and inspection readiness.
• Lead requirements definition, solution design, and implementation planning with cross-functional stakeholders.
• Provide Level-2 application support and vendor coordination for incident resolution and system enhancements.
• Maintain and continuously improve system documentation, including validation deliverables, SOPs, and operational records.
• Partner with Clinical Data Management to support data quality, flow, and operational needs.
• Execute core system governance activities, including performance monitoring, upgrades, disaster recovery testing, access reviews, and license and vendor management.
• Drive system adoption through training, documentation, and user enablement.
• Support audits and regulatory inspections, including inspection responses, remediation, and CAPA closure.
• Contribute to product roadmaps and release planning, balancing business value, regulatory risk, and technical feasibility.
• Manage and maintain collaborative relationships with core business partners.

IT Manager, Clinical Development Technologies

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

• 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.