4D Molecular Therapeutics

Lead and optimize data solutions, oversee clinical programming and data analytics, and ensure compliance with regulations in a biotech/pharma setting. | Extensive experience in data management within biotech/pharma, leadership in clinical trials, knowledge of FDA/EMA regulations, and proficiency with data management systems. | Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: The Director, Data Solutions & Optimization leads the development and execution of data solutions initiatives, overseeing EDC solutions vendors, managing clinical and EDC programming, database management, and data analytics. This role will manage and optimize key processes within data management and lead technological strategies, collaborating with internal teams and external vendors to drive innovation and operational efficiency. This role will play a pivotal role in aligning technological advancements with business goals, ensuring high-quality, timely delivery of critical clinical trial data. Data management is one of the essential functions of the Clinical Development organization at 4DMT. Together with the other two functions within the Data Science group, Biostatistics, and Statistical Programming, we provide critical support for the company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas. MAJOR DUTIES & RESPONSIBILITIES: 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. Other duties assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time QUALIFICATIONS: Education: B.A./B.S. degree or higher (life-science-related fields preferred), or equivalent experience. Experience: 10+ years of progressive experience in data management within biotech/pharma, including at least 5 years in a leadership role. Proven history of leading Data Programming for global clinical trials across all phases. Direct operational experience as Data Programming Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc. Knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR. Experience in oversight of CRO programming resources and performance assessments (FSP oversight experience is a plus). Expertise in Data Governance Execution and Framework Extensive knowledge of CDISC standards, including CDASH and SDTM. Experience in retina diseases and/or gene therapies is a plus. Other Qualifications/Skills: Strong leadership and team-building skills with ability to influence across functions. Strategic thinker with operational excellence mindset Proficient in using data management systems (e.g., Medidata Rave, Veeva) and data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.) Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials Knowledge of ICH GCP and other applicable regulatory rules and guidelines. Understand drug development process and risk-based trail management concepts. Proficient with MS Office (Worl, Excel, PowerPoint, etc.) Exceptional communication and stakeholder management skills. Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace. Excellent organization and project/time management skills Ability to multitask in a high-volume environment with shifting priority and conflicting deadlines Proven conceptual, analytical, and strategic thinking Excellent attention to details Travel: 5% Physical Requirements and Working Conditions: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met. Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Base salary compensation range: $214,000 - 250,000 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Manage end-to-end data management activities for clinical studies, ensuring compliance, quality, and timely delivery. | Requires 7+ years in clinical data management, experience with Phase 1-3 trials, vendor oversight, and proficiency with clinical data systems and standards. | Job Description: • 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. Requirements: • B.A./B.S. degree or higher (life-science-related fields preferred) or equivalent experience. • 7+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers of which at least three (3+) years in a lead study data manager role. • Experience with Phase 1-3 clinical trials required: retina diseases and/or gene therapies experience a plus. • Demonstrated experience in vendor oversight and cross‑functional team leadership. • In-depth knowledge and experience with CDISC data standards and models. • Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.) • Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials. • Knowledge of ICH GCP and other applicable regulatory rules and guidelines. • Knowledge of the clinical development process. • Proficient with MS Office (Word, Excel, PowerPoint, etc.) • Strong communication and interpersonal skills (written and verbal). • High attention to detail with excellent organizational and time‑management capabilities. • Ability to manage multiple projects in a fast-paced environment. • Proven conceptual, analytical and strategic thinking. • Excellent attention to details. Benefits: • Health insurance • 401(k) matching • Flexible working hours • Paid time off • Professional development opportunities

Provide medical oversight and leadership for ophthalmology clinical trials, ensuring safety, data integrity, and regulatory compliance. | Must have an M.D., clinical training in Ophthalmology, 8+ years in biopharma drug development, and experience with regulatory submissions and retinal disease trials. | Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: Reporting to the Chief Medical Officer the VP Late Stage Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development. We seek an experienced physician to play a critical role at 4DMT as we spearhead the introduction of the first intravitreally delivered genetic medicines for the treatment of the most common causes of irreversible blindness. The VP, Late Stage Ophthalmology will be the primary point person for medical oversight of clinical studies with responsibilities to include medical monitoring, review and interpretation of clinical trial data, clinical trial design, protocol development, and drafting of key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners. RESPONSIBILITIES: • 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 • Travel Domestic and Internationally as required ~20% QUALIFICATIONS: Education: • M.D. Degree • Clinical training in Ophthalmology • Retina fellowship training a plus • Board Certification (or equivalent) Experience: • Minimum of 8 years of biopharma industry experience in drug development • Phase 3 experience in retinal disease (s), diabetic eye disease highly preferred • Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus. • Experience with gene therapy, other areas of Drug Development and commercialization is a plus Skills: • Strong interpersonal skills and high emotional coefficient • Highly effective written and verbal communication skills • Excellent analytical, problem-solving and strategic planning skills. • Up to date understanding of the ophthalmic competitive landscape with a focus on retina • Prior Clinical Trial experience in Retina, Diabetic Eye Disease • Experience in participating or leading global regulatory interactions • Ability to understand and translate complex data to key messages • Ability to thrive in a fast-paced environment. • Proven ability to prioritize effectively • Proven ability to plan and conduct clinical trials ensuring high-quality trial execution and results within established timelines; demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory. • Track record of thinking strategically and executing to strategy • Demonstrated success in influencing colleagues and senior leaders in various departments. • Experience building and leading teams and driving engagement in a matrixed environment. • Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals. • Able to ensure accountability • Able to manage conflict • Comfortable managing ambiguity • Strong clinical and scientific knowledge of ophthalmology (and retinal disease in particular) • Track record of developing talent • Record of cultivating and managing internal and external cross-functional collaborations. • Demonstrates high integrity. • Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC • Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable. Base salary compensation range: $350,000 - $440,000 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities