4D Molecular Therapeutics
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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.
9 Jobs
Clinical Research Associate
4D Molecular Therapeutics4DMT 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.
Role Description 4DMT seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support the Company’s clinical trial activities. This position reports to the Associate Director, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities. The IHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment. Qualifications - A. or B.S. degree required - Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment - Experience supporting Phase 3 clinical trials preferred - Ophthalmology preferred - Working knowledge of clinical trial operations and ICH GCP guidelines - Experience with TMF/eTMF systems (Veeva Vault preferred) - Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) - Strong organizational skills and attention to detail - Ability to manage multiple priorities and meet deadlines - Strong interpersonal skills and ability to collaborate effectively with cross-functional teams and external partners - Willingness to travel as business needs demand (<5% anticipated) Requirements - 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 - Support ad hoc Clinical Operations projects as assigned - Other duties as assigned Benefits - Compensation range: $38.00 TO 52.00 /HOURLY - Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. Company Description 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.
Associate Clinical Trial Manager (Temporary)
4D Molecular Therapeutics4DMT 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.
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: 4DMT seeks a motivated and experienced Associate Clinical Trial Manager to support the Company's clinical trial activities. This position will be responsible for supporting the day-to-day operations of one Phase 3 clinical trials including trial conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives. MAJOR DUTIES & RESPONSIBILITIES: - 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 QUALIFICATIONS: Education: - A./B.S. degree required Experience: - At least 5 years of work experience supporting clinical trials Other Qualifications/Skills: - Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements - Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook - Ability to prioritize and manage competing priorities - Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners Travel: 20% 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 to 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: $62.00-72.00 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
Senior Manager, Data Management
4D Molecular Therapeutics4DMT 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.
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 Senior Manager, Data Management leads execution of end‑to‑end clinical data management activities for assigned studies and provides operational oversight to internal staff and external vendors. This role serves as a key member of cross‑functional study teams, contributing to planning, execution, and delivery of high‑quality clinical trial data across all phases. The Senior Manager possesses robust working knowledge of clinical data management processes and independently executes most tasks while also providing guidance to other Data Managers and vendor partners. 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: - 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: 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: - 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. - Experience in vendor management and performance assessments - In-depth knowledge and experience with CDISC data standards and models. Other Qualifications/Skills: - 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 (Worl, Excel, PowerPoint, etc.) - Strong communication and interpersonal skills (written and verbal) - Collaborative mindset with ability to work effectively. - 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 Travel: 0-10%, based on study needs. 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 to 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: $178,000 - 205,000 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
TMF Quality Specialist
4D Molecular Therapeutics4DMT 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.
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 We are seeking a TMF Quality & Oversight Specialist, reporting to the Senior Manager, Clinical Records. This contractor will support the review, quality oversight, and maintenance of Trial Master File (TMF) documentation in accordance with GCP, ICH E6, regulatory requirements, and 4DMT SOPs. In addition to QC review, the role will help develop and execute Oversight Review processes in Veeva Vault eTMF and support system change requests by representing the Business Process Owner (BPO) perspective. This work is critical to strengthening TMF oversight and ensuring inspection readiness. MAJOR DUTIES & RESPONSIBILITIES: QC Review & Documentation Support - Perform detailed QC reviews of TMF documents to verify metadata accuracy, confirm proper filing, and ensure compliance with ICH GCP, regulatory standards, and internal SOPs. - Identify documentation gaps, inconsistencies, or quality issues and collaborate with TMF Operations team members to resolve them promptly. - Support ongoing TMF review activities throughout the study lifecycle to help ensure quality, timeliness, and completeness. - Assist with audit and inspection preparation by supporting the TMF team in documentation readiness activities. Oversight Review Process Development - Contribute to the continuous improvement of Oversight Review processes within Veeva Vault eTMF, including workflows, dashboards, and metrics. - Support the development of review standards, success metrics, and monitoring tools that provide visibility into TMF quality, completeness, and inspection readiness. - Support TMF Operations leadership in identifying process improvement opportunities and contributing to the development of new tools, workflows, and best practices. Business Process Owner (BPO) Support for System Enhancements - Assist in preparing business requirements, documenting user needs, and participating in validation testing and user acceptance activities from the BPO perspective. - Provide input into change control documentation and support cross-functional collaboration with IT, Quality, and Managed Services teams during configuration updates. - Help develop training materials, reference guides, and user communications to support adoption of new functionality or process changes. QUALIFICATIONS: REQUIRED EXPERIENCE: - Minimum 5 years of relevant experience in TMF Operations, including extensive hands-on work with Veeva Vault eTMF. - At least 2 years performing TMF QC review, applying knowledge of clinical documentation content and metadata standards. - Experience supporting TMF planning, implementation, and configuration activities, including review of TMF Plans and participation in system setup or enhancements. - Demonstrated understanding of the CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation Practice, and regulatory documentation requirements. PREFERRED EXPERIENCE: - Experience partnering with or overseeing CROs performing TMF activities. - Hands-on involvement in system reporting, dashboard development, or configuration testing within Veeva Vault. - Exposure to multiple phases of clinical trial conduct (startup through close-out and TMF archiving). - Familiarity with additional Veeva products such as CTMS or Vault RIM. REQUIRED SKILLS: - Proficiency in Microsoft Office Suite for collaboration with team members. - Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata. - Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment. - Strong attention to detail and organizational skills including the ability and drive to follow through on detailed tasks to closure. - Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Travel: 0% 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 to 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). Hourly Rate: $60.00 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
Clinical Records Associate
4D Molecular Therapeutics4DMT 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.
Role Description We are seeking a Clinical Records Associate for our TMF Operations Department Reporting to the Associate Director of TMF Operations. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT’s Standard Operating Procedures (SOPs) as appropriate. Qualifications - A./B.S. degree (preferably in a scientific or healthcare-related field) preferred - High school diploma required - A B.S. with 2+ years relevant experience including extensive experience with Veeva Vault TMF or a H.S. diploma with 6+ years relevant experience. - 2+ years of TMF QC Review and knowledge of clinical documentation content required. - Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness) Requirements - Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice). - Expert knowledge of cross-functional TMF content requirements throughout the trial. - Proficiency in Microsoft Office Suite for collaboration with team members. - Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata. - Excellent communication skills (written and verbal). - Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment. - Strong attention to detail and organizational skills. - Ability and drive to follow through on detailed tasks to closure. - Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. - Development and maintenance of TMF Plans. - Demonstrated understanding of the DIA Reference Model filing structure and contents. Benefits - Base salary compensation range: $92,000 - $116,000 - 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.
Director, Biostatistics
4D Molecular Therapeutics4DMT 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.
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 incumbent 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. MAJOR DUTIES & RESPONSIBILITIES: - 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 enables 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. - Leads and/or participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency. - Supports the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis. - Plays a critical role in shaping team development and contributing to departmental strategy. - Stays abreast of and contributes to scientific advances in the field. - 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 QUALIFICATIONS: Education: - M.S. required - PhD preferred Experience: - 8+ years of pharmaceutical industry experience with a PhD, or 10+ years with an MS. - Hands-on familiarity with common and advanced statistical methodology. - Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets. Other Qualifications/Skills: - Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery. - Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials 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 to 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: $276,000 - 319,000 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
Intern
4D Molecular Therapeutics4DMT 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.
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 Competitive Intelligence Intern will support cross-functional teams by providing research, analysis, and insights that help guide strategic decision-making across therapeutic areas. This role offers hands-on exposure to competitive intelligence methodologies, the pharmaceutical lifecycle, and the broader biotech landscape. The intern will synthesize scientific, clinical, and commercial information to help identify market trends, competitive threats, and emerging opportunities. This position is ideal for a graduate-level student with strong scientific training and an interest in strategy, market analysis, or the business of biotechnology. Note: the position is part‑time, structured as a 10‑hour‑per‑week internship for an individual in ET time zone, or an individual who can be available during the weekday hours of 8-10am ET. The internship is expected to last 4-8 months, with exact timing to be finalized with the selected candidate. MAJOR DUTIES & RESPONSIBILITIES: - Track developments within select therapeutic areas, including emerging technologies, and investigative treatment approaches - Conduct research on competitor pipelines, clinical trial activity, mechanisms of action for investigative products, regulatory updates, and market activities - Monitor scientific publications, conference abstracts, and industry news to identify emerging trends or competitive signals - Report key insights promptly through clear written summaries, presentations, or targeted updates Analyze scientific and clinical data to support development of disease landscape analyses Evaluate scientific literature, clinical trial data, data from Competitive Intelligence platforms, and product profiles to support competitive assessments Summarize complex scientific and clinical findings into clear, concise insights for internal stakeholders - Translate scientific and competitive findings into insights that help inform strategic questions, including market positioning, differentiation, and potential risks - Integrate market insights to shape opportunity assessments and product positioning - Analyze and synthesize market data to assess potential commercial uptake, competitive positioning, and key dynamics shaping the commercial landscape for emerging therapies - Identify commercial trends, demand signals, and adoption analogs to inform scenario planning, opportunity assessments, and competitive strategy recommendations Contribute to high-quality PowerPoint deliverables, reports, dashboards, and summaries for cross‑functional meetings related to business development initiatives - Ensure accuracy, clarity, and scientific rigor across all Competitive Intelligence outputs - Generate and maintain reoccurring and ad-hoc Competitive Intelligence reports QUALIFICATIONS: Education: - Currently enrolled in, or recently graduated (within six months) from an M.S. or Ph.D. program in a relevant life science discipline Experience: - Experience conducting literature reviews, analyzing scientific publications, and synthesizing scientific findings - Exposure to, or coursework, in drug development, biotechnology, or healthcare markets - High-level understanding of the pharmaceutical product lifecycle - Knowledge in gene therapy and/or ophthalmology is preferred, but not required Other Qualifications/Skills: - Demonstrated interest in competitive intelligence, commercial strategy, or healthcare consulting through coursework, organizational involvement, or related experience - Strong understanding of biological mechanisms underlying disease - Excellent communication skills, including scientific writing, analytical synthesis, and presentation development - Advanced proficiency in Microsoft Office, including Excel, PowerPoint, Word, and Outlook - Ability to conduct qualitative and quantitative research using relevant databases and analytical tools - Project-oriented mindset with the ability to take full ownership of assigned topics and deliverables - Strong analytical and problem-solving skills - Growth mindset with the flexibility to take on new assignments in a dynamic, fast-paced environment Travel: 0% (Full-Time Remote) 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 to 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). Hourly Rate: $25/hourly 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
Associate Director, Clinical Operations
4D Molecular Therapeutics4DMT 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.
Role Description The Associate Director, Clinical Operations will be responsible for implementation, execution and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations. Major Duties & Responsibilities - 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 and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans. - Provide guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing. - 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 (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees. - Ensure that each clinical trial is always inspection ready. - Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET). - May sit on product cross-functional core teams as Clinical Operations SME. - Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready. - Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (e.g., Clinicaltrials.gov). - Address escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans. - Coordinate the development and maintenance of clinical SOPs as pertains to the program and provide review/input into cross-functional SOPs and other documents. - Support development and review of protocols/amendments, study documents and plans, and operational execution. - Actively participate in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provide ongoing surveillance of progress and ensure that contingency plans are triggered as and where appropriate. - Contribute to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials. Qualifications - B.S./B.A. in Life Science or related discipline required. - Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred. - Clinical Research certification preferred, but not required. Requirements - B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience. - Require 1+ years ophthalmology trial experience as well as late phase trial experience. - Relevant experience in clinical trial execution across all phases. Other Qualifications/Skills - Proven ability to recruit, retain, organize, and motivate clinical operations personnel. - Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources. - Ability to manage and oversee programs that have corporate-wide impact. - Ability to develop and manage functional and clinical trial-specific budgets. - Must be self-motivating; prioritize and manage a large volume of work; show attention to detail. - Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance. - Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials. - Ability to be flexible and adaptable to changing business needs. - Excellent communication and interpersonal skills. - Must be able to write clearly and summarize information effectively. - Must be able to present complex information to various audiences. Travel Anticipate 20%, or as trial needs demand. 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 to 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). Compensation Base salary compensation range: $180,000 - 200,000. 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. Equal Employment Opportunity 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.
Clinical Trial Manager
4D Molecular Therapeutics4DMT 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.
Role Description The Clinical Trial Manager will support the Company's clinical trial activities. This position reports to the Director of Clinical Operations. This will be responsible for management of the day-to-day operations of one or more phase 1-3 clinical trials including trial start-up, conduct, and close-out activities. Qualifications - B.A./B.S. degree - 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management - Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management - Strong clinical study management skills - Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners - Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met - Excellent communication skills to effectively disseminate information to project team and outside parties - Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management - Clinical research knowledge and cross-functional understanding of clinical trial methodology - Excellent organizational, conflict resolution, prioritization, and negotiation skills - Proven ability in creative problem-solving and exercising sound judgment - Team-oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners - Ability to handle a high volume of highly complex tasks within a given timeline - Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance - Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook - Working knowledge of MS Project for development and update of clinical study timelines Requirements - Travel: 5% - Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. - Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Benefits - Base salary compensation range: $150,000 - 172,000 - 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. Company Description 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.