4D Molecular Therapeutics

Director

• 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 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 recognized clinical expert for assigned programs.
• Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for Executive Team, Board of Directors, Advisory Boards and Data and Safety Monitoring Committees [DSMC])
• Together with Medical Director of Ophthalmology, 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 other clinical documents.
• 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
• 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

Senior Director, Clinical Science

Medical Director

• Act as medical monitor in clinical ophthalmology studies with a focus on safety, data review and analysis of emerging data
• Contribute to study related documents including but not limited to study synopsis, protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, and other regulatory submissions and project-related documents. Accountable for the medical content of documents.
• Analyze, interpret, and organize data for presentations and publications
• Interact with external experts to gather input. Organize scientific advisory board meetings and data safety monitoring committee meetings
• Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings
• Ability to communicate with Investigators and research site staff to ensure rigorous and compliant study conduct
• Able and willing to travel

• Lead statistical programming activities for assigned programs, including oversight of CRO deliverables.
• Develop, review, and execute SAS programs to produce SDTM/ADaM datasets, tables, figures, and listings in accordance with SAPs.
• Perform quality control (QC) of programming deliverables to ensure accuracy, consistency, and compliance.
• Support ad hoc, exploratory, and postdoc analyses as needed.
• Prepare and standardize data packages for regulatory submissions (BLA, NDA, MAA), including ISS/ISE deliverables.
• Ensure CDISC compliance using implementation guides and validation tools (e.g., Pinnacle 21).
• Review and approve dataset specifications, output shells, and reviewer’s guides (SDRG, ADRG).
• Develop and maintain programming SOPs, guidelines, macros, and reusable tools.
• Contribute to process improvement and standardization initiatives within the Biometrics function.
• Stay current with evolving regulatory requirements, industry standards, and emerging technologies.
• Represent Statistical Programming in internal and external meetings.
• Partner with Biostatistics, Data Management, Regulatory, and Clinical teams to align deliverables and resolve issues.
• Communicate technical concepts clearly to both technical and non-technical stakeholders.
• Manage internal programming resources and mentor junior staff.
• Participate in CRO selection, contracting, and performance evaluation.
• Ensure vendor deliverables meet agreed timelines, quality standards, and contractual obligations.

Associate Director, Statistical Programming

Manager

• Execute oversight activities in alignment with the Clinical Oversight Monitoring Plan and related SOPs.
• Partner with the Associate Director to refine and implement oversight tools, trackers, and metrics dashboards.
• Conduct quality control (QC) review of monitoring visit reports and follow-up letters to assess completeness, accuracy, and compliance with monitoring expectations.
• Track visit scheduling, report completion metrics, protocol deviations, and issue resolution to identify trends and risks across CRO, monitor, and site levels.
• Support the development and maintenance of monitoring oversight dashboards and performance metrics (e.g., timeliness, completeness, issue closure, out-of-window visits).
• Assist in implementation of risk-based oversight elements such as key risk indicators (KRIs), key performance indicators (KPIs), and quality tolerance limits (QTLs).
• Collaborate cross-functionally with Clinical Operations, Quality Assurance, and Data Management to ensure consistency in monitoring-related communications, escalation pathways, and issue management.
• Support vendor oversight by reviewing CRO performance reports, contributing to issue escalation, and tracking CAPA progress.
• Participate in inspection readiness activities, document reviews, and process audits to ensure oversight documentation is accurate and current.
• Assist in process improvement initiatives by analyzing oversight data and identifying areas for refinement or standardization.
• Maintain oversight documentation, trackers, and archives to ensure audit and inspection preparedness.
• Support onboarding and training of new COM team members and vendor associates on oversight tools and processes.
• Travel as required (estimated up to 20%).
• Other duties as assigned. Management reserves the right to adjust responsibilities as business needs evolve.

Senior Manager, Clinical Oversight Monitoring

• Lead Data Management of clinical studies with minimal guidance
• Manage data management activities with CROs and vendors
• Review protocols and eCRF data requirements
• Develop data management plans and coordinate EDC system design
• Attend study meetings providing updates and metrics
• Ensure data quality through reconciliation activities

Associate Director, Data Management

Vice President

• Reporting to the Chief Medical Officer the VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development.
• Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence throughout study execution.
• Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review, while maintaining personal accountability for real-time monitoring activities and timely delivery of critical clinical trial outputs.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide oversight and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents and other regulatory submissions or documents as appropriate.
• Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, BOD meetings, etc.
• Represent 4DMT and Lead interactions and collaborations with potential partners.
• Represent the Ophthalmology Therapeutic Area with key external stakeholders, including patients and patient advocacy groups, external experts, investors, and the ophthalmic and biotech business communities.
• 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.

Vice President, Clinical Development, Ophthalmology

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis
• Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies
• Responsible for the development of randomization schema on assigned randomized studies
• Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications
• Responsible for the development of statistical reports summarizing the data analysis results
• Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications
• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials
• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
• 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