4D Molecular Therapeutics

• Support 4D‑150, a gene therapy in late-stage development for retinal vascular diseases • Plan, develop, and deliver high-quality clinical and regulatory documents across late-stage development • Collaborate closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, Quality, and external partners • Oversee development, coordination, and execution of key BLA modules • Manage internal and external medical writing resources for timely, high-quality regulatory deliverables. • Author, review, and coordinate key clinical and regulatory documents for the 4D‑150 Phase 3 program as well as for the early-phase lung program.

• Set, communicate and drive strategy for Translational products in alignment with the broader organization of 4DMT • Prioritize and allocate resources, both within Translational and beyond, to meet portfolio needs • Lead the decision-making process with other relevant functional group heads regarding indications, targets and products’ progression from concept, design, preclinical development and Phase 1-2 clinical testing. • Provide input on scientific strategy from the earliest consideration of new targets through development, including risk, scientific challenges, timing of resource investment and development of go/no go decisions • Direct and coordinate the implementation of preclinical study programs for pharmacology studies in support of the lead to candidate optimization process • Design, implement and write-up comprehensive series of pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles and generate GLP toxicology and bio-distribution packages suitable for supporting IND filings • Manage budgets and headcounts • Design, implement and manage externally facing in vivo studies with CROs and academic centers, including drafting proposals, budget oversight and managing deliverables • Resource planning; hiring and mentoring talents; building the team and technical capabilities • Build collaborations with relevant functions at 4DMT; represent own function at the corporate level and externally • Provide direct hands-on responsibility for all Translational interactions as well as grant writing and management with rare disease advocacy groups • Participate on project teams and direct activities to ensure regulatory compliance of pre-clinical and clinical research activities • Support regulatory affairs in their preparation, review and submission of necessary pre-clinical and clinical regulatory information to regulatory agencies worldwide • Contribute to defining of clear human POC study outcome criteria for decision-making on new product candidates • Contribute senior level expertise to alliance, business development, due diligence exercises with external entities and licensing meetings as well as other critical external interfaces such as public health regulatory bodies • 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

• Support study execution across start-up, conduct, and close-out phases • Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors • Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines • Support site initiation, ongoing site management, and site close-out activities • Assist with identification, documentation, tracking, and follow-up of site issues • Support oversight of CRO monitoring activities • Review monitoring visit reports and follow up on action items and unresolved findings • Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate • Support inspection readiness and audit activities • Maintain accurate tracking tools for assigned studies, including: • Site start up and activation status • Subject enrollment and visit status • Essential document collection and TMF status • Vendor reconciliation • Assist with preparation of study status reports and metrics • Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements • Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans • Perform TMF quality control activities and support TMF audits and study close out • Support organization and coordination of internal team meetings, investigator meetings, and other study related meetings • Prepare meeting materials, take meeting minutes, and maintain action item logs • Support communication of study updates to internal stakeholders

• Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities: • Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance. • Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events. • Ensure principles of Risk Management are applied to the Clinical Study per ICH E6. • Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency. • Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites. • Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs. • Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries.

• Manage full-cycle recruitment for assigned roles, including sourcing, screening, interviewing, and offer negotiation • Partner with hiring managers to understand hiring needs, define role requirements, and develop candidate profiles • Proactively source and engage candidates using a variety of channels, including LinkedIn Recruiter and networking • Draft and refine job descriptions in partnership with HR and Total Rewards, ensuring alignment with leveling and compensation frameworks • Coordinate and drive interview processes, including scheduling, debrief facilitation, and delivery of structured feedback • Support offer development and negotiation in alignment with company compensation philosophy • Partner with external search firms and staffing agencies as needed; help ensure quality and cost-effectiveness of vendor support • Track and maintain recruiting data, ensuring accuracy in systems such as Greenhouse and contributing to hiring metrics and reporting • Support execution of hiring plans in alignment with approved headcount and business priorities • Identify opportunities to improve recruiting processes, tools, and candidate experience • Stay informed on industry trends and talent market dynamics within biotech/pharma • Promote inclusive hiring practices and support efforts to mitigate bias in the recruiting process • Participate in special projects and broader Talent Acquisition or HR initiatives as needed

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial • Lead cross-functional study execution team in support of study deliverables • Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership • 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 such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files • Negotiate and finalize site contracts and budgets • Manage clinical trial budgets, providing ongoing financial reporting and projections • Perform and manage data review process on an ongoing basis • Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed • Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues.

• 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

• Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation. • Serve as medical monitor for clinical studies, ensuring patient safety and data integrity. • Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions. • Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success. • Engage with external experts, organize advisory boards, and contribute to scientific and medical communications. • Identify and mitigate clinical and programmatic risks. • Support portfolio development and evaluation of new clinical opportunities. • Represent the company in regulatory and scientific forums as needed.

• 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.

• 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