GENERAL SUMMARY: 

The Principal Medical Writer will support 4D‑150, a gene therapy in late-stage development for retinal vascular diseases, including nAMD and DME, and associated BLA‑enabling activities as well as clinical stage work within the lung program. This role is responsible for the planning, development, and delivery of high‑quality clinical and regulatory documents across late‑stage development, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, Quality, and external partners. This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical writing resources to ensure timely, high‑quality regulatory deliverables.

The ideal candidate brings strong late clinical‑stage medical writing experience, demonstrated ability to manage complex timelines, and a deep understanding of regulatory expectations for global Phase 3 programs and BLA readiness.

MAJOR DUTIES & RESPONSIBILITIES: 

• Provide oversight for the planning, development, and execution of BLA modules, working closely with Clinical Science, Regulatory Affairs, Data Science, and Quality to ensure alignment with submission strategy and timelines.
• Lead and coordinate external medical writers and vendors, including selection, scope definition, timeline management, content review, and quality oversight.
• Ensure consistency, scientific accuracy, and regulatory alignment across BLA components and supporting clinical documents.
• Serve as a key point of integration between internal subject matter experts and external writing resources to support efficient document development and review cycles.
• 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, including but not limited to protocols, protocol amendments, CSRs, IBs, DMC materials, briefing documents, and BLA‑enabling content.
• Lead document planning and timeline management in collaboration with cross‑functional teams to support aggressive development milestones.
• Ensure consistency, clarity, and scientific accuracy across clinical documents, aligning with regulatory standards and internal expectations for quality.
• Partner closely with Clinical Science, Biostatistics, and Clinical Operations to integrate data interpretations, safety narratives, and efficacy analyses.
• Manage document review cycles, address comments, and ensure timely resolution of feedback from internal stakeholders and external vendors.
• Maintain document version control and adherence to internal SOPs, templates, and quality standards.
• Contribute to continuous improvement of writing processes, tools, and templates to support scale‑up of late‑stage development activities.
• Other duties as assigned

QUALIFICATIONS: 

Education

• Advanced degree in life sciences (MS, PhD, PharmD, MD) preferred; Bachelor’s degree required.

Experience

• 5+ years of medical or clinical writing experience in biotech, pharmaceutical, or CRO settings.
• Direct experience supporting Phase 3 clinical trials required; direct experience supporting early clinical trials (Phase 1/2) preferred.
• Prior experience authoring or contributing to BLA‑enabling documents strongly preferred.

Other Qualifications / Skills

• Strong understanding of ICH guidelines, FDA regulatory expectations, and clinical development processes.
• Demonstrated ability to manage multiple complex deliverables under tight timelines.
• Excellent written communication skills with attention to scientific detail and clarity.
• Proven ability to work effectively in a fast‑paced, cross‑functional environment.
• Experience in gene therapy is a plus.
• Experience with leveraging AI-enabled tools to aid in document authoring is a plus.

Travel

• Minimal; occasional travel (<10%) as needed.

Physical Requirements and Working Conditions:

Sedentary work involving extended periods of sitting, typing, and screen use. Repetitive hand and finger movements required. Virtual meetings may occur across time zones.

Base salary compensation range: $180,000 - 202,000

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.

GENERAL SUMMARY

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.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• 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

 Monitoring Oversight

• 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

 Tracking & Study Oversight

• 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

 Regulatory Documentation & TMF Management

• 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

 Study Communications & Meetings

• 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

 Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<5% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• 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

Other Qualifications/Skills: 

• 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

Travel: Willingness to travel as business needs demand (<5% anticipated)

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 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. 

GENERAL SUMMARY

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.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• 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

 Monitoring Oversight

• 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

 Tracking & Study Oversight

• 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

 Regulatory Documentation & TMF Management

• 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

 Study Communications & Meetings

• 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

 Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<5% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• 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

Other Qualifications/Skills: 

• 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

Travel: Willingness to travel as business needs demand (<5% anticipated)

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 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. 

GENERAL SUMMARY

This Executive Director position will report to the Senior Vice President, Research & Early-Stage Product Development and lead a team of translational scientists and drug development experts tasked with bringing innovative gene therapies to patients.  The incumbent will have a high level of passion for 4DMT’s mission and the ability to operate as an effective strategic and tactical thinker. They will also be effective as a hands-on manager and supervisor of individual work. Candidates should have a PhD or MD/PhD degree (or equivalent) in Biological Sciences or a related discipline, with significant experience in pharmaceutical research and development.  They will lead a preclinical and translational group responsible for: (1) developing target-engagement biomarkers and clinical biomarkers with relevance to Proof of Concept (POC) gene therapy studies, (2) conducting laboratory and in silico analyses of biomarker readouts generated in the relevant Phase 1 and Phase 2 gene therapy studies, (3) performing immunological assays and analyses relevant to detecting host immune responses to 4DMT gene therapy vectors in the clinical trial setting, and (4) overseeing outsourced performance of preclinical pharmacology and toxicology studies of 4DMT gene therapy vectors, in partnership with external CROs. This role will interact and collaborate with multiple functions at 4DMT, including but not limited to Clinical Science and Operations, Regulatory Affairs, Discovery & Innovation, Commercial, and CMC.

MAJOR DUTIES & RESPONSIBILITIES:

• 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

QUALIFICATIONS: 

Education:

• PhD, MD/PhD, MD or equivalent

Experience:

• 12+ years of relevant preclinical and/or translational sciences experience within the Biotech or similar industry
• 4+ years of management experience or other specific work experience
• Experience with preclinical, translational, and clinical R&D
• Prior leadership position/s within the pharmaceutical/biotech industry or academic medical centers, with a significant history of research and translational experience
• Reputation for inspiring a culture of continuous improvement, innovation and quality, leading and mentoring at the highest level of achievement

Skills:

• Team leadership skills and experience in a matrixed organization
• Ability to support and impact experts, scientists and project deliverables across functions in research, development and beyond
• Strong communication skills both written and oral with demonstrated ability to present ideas, information, and data effectively via one-on-one discussions, team meetings, and presentations to executive leadership
• Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
• Self-starter who proactively establishes effective working relationships and builds partnerships with other disciplines
• Adaptability, flexibility, independence and resourcefulness; as an active participant in a vibrant small company culture, rolls up sleeves and manages multiple activities in parallel.
• Ability to proactively identify challenges; possesses strategic foresight and implements appropriate courses of action
• Excellent verbal and written communication skills

Travel: 5-10%

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: $270,000 - 342,000

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. 

GENERAL SUMMARY

4DMT seeks a motivated and detail-oriented In-House Unmasked Clinical Research Associate (uIHCRA) to support the Company’s clinical trial activities. This position reports to the Unmasked Clinical Trial Manager, 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.  Role requires extensive experience in unmasked clinical settings. 

The uIHCRA 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.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary unmasked sponsor point of contact for unmasked clinical site staff in collaboration with CRO field unmasked CRAs/monitors
• Communicate directly with unmasked site staff and unmasked 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

Monitoring Oversight

• Support oversight of unmasked CRO monitoring activities
• Review unmasked monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Unmasked Clinical Trial Manager, Clinical Operations as appropriate
• Support inspection readiness and audit activities

Tracking & Study Oversight

• Maintain accurate tracking tools for assigned studies, including:
  • Site start up and activation status
  • Initial IP supply and Ancillary supply
  • Site visit activities
  • IP Shipment status and delivery
  • Assist with preparation of study status reports and metrics

Regulatory Documentation & TMF Management

• Collect, review, and track site applicable SOPs
• Ensure timely filing of unmasked documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out
• Support the review of Quality Incidents and follow up activities

Study Communications & Meetings

• Support organization and coordination of internal team 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

Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<15% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment on the unmasked side
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred

Other Qualifications/Skills: 

• 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

Travel: Willingness to travel as business needs demand (<15% anticipated)

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 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. 

GENERAL SUMMARY:

The Senior Recruiter (ideally based in the Bay Area or San Diego) is responsible for driving full-cycle recruitment across 4DMT, partnering closely with hiring managers and Associate Director, Talent Acquisition to deliver high-quality talent aligned with the company’s growth objectives. This role supports execution of the Talent Acquisition strategy, manages external and ensures a consistent, efficient, and high-caliber hiring process. The Senior Recruiter will play a critical role in sourcing, engaging, and closing top talent in a competitive biotech market.

RESPONSIBILITIES:

• 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
• Other duties as assigned; this role offers opportunities to contribute to broader HR and organizational initiatives

QUALIFICATIONS:

Education:

• Bachelor’s degree or equivalent
• HR Certification is a plus

Experience:

• 8+ years of full-cycle recruiting experience in biotech or pharmaceutical industry, as part of the internal talent acquisition team
• Strong experience hiring of clinical roles; hiring of commercial roles is a plus
• Proven ability to manage multiple requisitions across technical and business functions
• Strong proficiency with recruiting systems and tools, including Greenhouse and LinkedIn Recruiter
• Experience partnering with external search firms and staffing agencies  

Skills:

• Strong execution focus with the ability to manage multiple priorities in a fast-paced environment
• Solid understanding of recruiting best practices and applicable employment laws
• Ability to build effective partnerships with hiring managers and cross-functional stakeholders
• Strong judgment and ability to handle confidential and sensitive information
• Excellent communication, organization, and follow-through
• Strong interpersonal skills and ability to influence without authority

Hourly compensation range: $69.00 - $95.00

Please note, the hourly compensation range offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY

The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple, global, 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP). This position reports to the Senior Director, GCP Compliance and Quality Systems and contributes to the development, implementation, and successful execution of the CQA mission, objectives, and strategic plan.

MAJOR DUTIES & RESPONSIBILITIES:

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

Support investigation and management of specific Clinical Study Quality Events as assigned:

• Monitor, track, and facilitate the completion of formal corrective and preventive actions (CAPAs) to address identified Clinical Study Quality Events, including potential serious breaches of GCP.

Support a quality-focused work environment in Clinical that fosters learning, respect, open communication, collaboration, integration, and teamwork:

• Work with Clinical stakeholders to develop GCP compliance training materials and conduct training
• Partner with Clinical team to review, update and maintain related SOPs, identify the need for new SOPs, and support the review of new SOPs as needed
• Work with Clinical stakeholders to support Training, Development, and Implementation of 4DMT Clinical Study Risk Management Process/Tools to ensure principles of Risk Management are applied to 4DMT Clinical Studies per ICH E6
• Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes

Support preparedness / readiness / management of BIMO inspections:

• Develop/support GCP inspectional readiness plans and lead inspectional readiness activities
• Host and/or assist with management of GCP-related inspections
• Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.

QUALIFICATIONS: 

Education:

• S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred.

Experience:

• 10+ years of experience or advanced degree with 7+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
• Proven experience with GCP Quality Management Systems, quality support, and quality oversight of global clinical trials
• Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits and overseeing global clinical trials, including in APAC.
• Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
• (Optional) 5+ years of management experience or other specific work experience

Other Qualifications/Skills:

• In-depth understanding of GCP requirements for investigational products
• Excellent communication skills, both oral and written
• Excellent interpersonal skills, collaborative approach essential
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust to workload based upon changing priorities

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: $205,000 - $235,000

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.

GENERAL SUMMARY: 
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.  This is a 6 month contract remote opportunity.    
 
MAJOR DUTIES & RESPONSIBILITIES: 

Trial Management:  

• 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 

• Participates in service provider selection process as a part of outsourcing activities 

• Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required 

• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations 

• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers 

• In conjunction with legal  group,  facilitate  the  development  of  clinical  trial agreements and other relevant documents 

• Manage clinical trial budgets, providing ongoing financial reporting and projections 

• Negotiate and finalize site contracts and budgets 

• 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 

• Ensures tracking and review of protocol deviations and assesses impact on study data 

• Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget 

• Provides oversight for forecasting of clinical supplies, including study drug and supplies 

 Department Management:  

• May manage and/or oversee work of junior Clinical Operations staff 

• May support development and review of Clinical SOPs and other department initiatives 

• Travel as needed to sites, conferences, industry meetings 

• Other duties as may be assigned 

 
QUALIFICATIONS: 

Education: 

• B.A./B.S. degree 

 Experience: 

• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management 

 Other Qualifications/Skills: 

(non-technical and technical skills) 

• 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 include Word, Excel, PowerPoint, and Outlook 

• Working knowledge of MS Project for development and update of clinical study timelines 

 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). 

HR ONLY: Hourly Compensation Range: $84.00 - 94.00

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.  

GENERAL SUMMARY: 

The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus on retina programs. This role provides strategic and operational clinical leadership across cross-functional study teams and serves as a key medical expert internally and externally.

MAJOR DUTIES & RESPONSIBILITIES: 

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.

QUALIFICATIONS: 

Education: 

• Medical Degree (M.D.), OD, PhD, PharmD or equivalent
• Residency training in Ophthalmology with a preference for subspecialty training in retina
• Board certification a plus
• Retina fellowship training a plus

Experience: 

• 5+ years of clinical ophthalmology research in the biopharmaceutical industry
• Experience with Phase 3 retina clinical trials
• Experience with gene therapy a plus.
  • Experience in other phases (Phase 1, 2, 4) of clinical research a plus.
  • Experience with NDA/BLA/MAA submission a plus.
  • Experience writing clinical research protocols and acting as a medical monitor 
  • Experience in data analysis, data interpretation, and medical writing

Other Qualifications/Skills: 

• Knowledge of ICH-GCP and FDA regulatory guidelines.
• Knowledge of international regulatory guidelines a plus.
• Effective written and verbal communication skills, including public speaking

Travel: 15%

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: $275,000 - 325,000

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.

GENERAL SUMMARY:   

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   

• Provides 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., Clincialtrials.gov)  

• Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans  

• Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents  

• Supports development and review of protocols/ amendments, study documents and plans, and operational execution  

• Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate  

• Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.  

  QUALIFICATIONS:   

 Education:  

• 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 

 Experience:   

• 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 

• Requires 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).

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.  

GENERAL SUMMARY:
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.  

MAJOR DUTIES & RESPONSIBILITIES:

Trial Management:

• 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
• Participates in service provider selection process as a part of outsourcing activities
• Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required
• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
• In conjunction with legal  group,  facilitate  the  development  of  clinical  trial agreements and other relevant documents
• Manage clinical trial budgets, providing ongoing financial reporting and projections
• Negotiate and finalize site contracts and budgets
• 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
• Ensures tracking and review of protocol deviations and assesses impact on study data
• Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget
• Provides oversight for forecasting of clinical supplies, including study drug and supplies

 Department Management:

• May manage and/or oversee work of junior Clinical Operations staff
• May support development and review of Clinical SOPs and other department initiatives
• Travel as needed to sites, conferences, industry meetings
• Other duties as may be assigned

QUALIFICATIONS:

Education:

• B.A./B.S. degree

Experience:

• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management

Other Qualifications/Skills:

(non-technical and technical skills)

• 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 include Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for development and update of clinical study timelines

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: $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.

GENERAL SUMMARY:

The Clinical Technology, IT professional is the accountable owner for the strategy, delivery, and operational integrity of information systems supporting 4DMT’s Clinical Research and Development organization. This role ensures clinical systems are fit for purpose, inspection-ready, and maintained in a validated state, while advancing technology solutions that enable efficient, compliant clinical execution.

The position serves as the primary liaison between Clinical R&D, Data Management, IT, and external vendors, driving alignment, governance, and disciplined system ownership across the full lifecycle—from design and implementation through operation and retirement.

MAJOR DUTIES & RESPONSIBILITIES:

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

QUALIFICATIONS:

• 8–12+ years of experience implementing and operating technology solutions supporting clinical research and development.
• Proven experience across the CSV lifecycle, including validation, production deployment, support, and decommissioning.
• Strong working knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR.
• Broad technical fluency across applications, infrastructure, cloud platforms, integrations, and operations.
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related discipline (or equivalent experience).

Preferred Experience:

• Collaboration with Clinical Data Management and Biometrics teams.
• Experience with Medidata Rave, SAS (Grid, Viya, 9.4), Spotfire, and Veeva TMF and RIM.
• Experience operating systems in Google Cloud environments.
• Strong vendor management and service governance experience.
• Experience with product road mapping, KPIs, and SLAs aligned to clinical priorities.
• Exposure to low-code platforms and applied AI in clinical research.

Base salary compensation range: $110,000 - $150,000