4D Molecular Therapeutics · 2 months ago
Senior Director, Clinical Science
United States
Full-time
Remote
Director/Executive
$268K/yr - $341K/yr
8+ years exp4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Senior Director, Clinical Science will facilitate the advancement of ophthalmology gene therapy programs and support clinical and scientific aspects of assigned clinical programs.
BiotechnologyGenetics
Responsibilities
Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials
Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates
Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct
Prepare and communicate clear overviews of trial results
Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution
Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives
Act as recognized clinical expert for assigned programs
Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for Executive Team, Board of Directors, Advisory Boards and Data and Safety Monitoring Committees [DSMC])
Together with Medical Director of Ophthalmology, serve as a point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions
Maintains knowledge of ICH-GCP and FDA IND, and external regulations and procedures
Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and other clinical documents
Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions
Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
Qualification
Required
A./M.S. in a biological/health science field is required
A./M.S. with 12+ years Clinical science experience, or OD, PhD or PharmD with 8+ years of experience with 5+ years of drug development with experience in ophthalmology drug development, preferably in retinal disease
Advanced experience in clinical trial design, implementation, regulatory document preparation and statistics
Phase 3 experience, retinal gene therapy experience, NDA/BLA/MAA submission experience
Ability to interpret, analyze, and present clinical data
Thorough understanding of the drug development process
Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
Demonstrated ability to communicate and write clearly, concisely, and effectively
Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy
Understanding of trial design and statistics
Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment
Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams
Preferred
OD, PhD, or PharmD preferred
Company
4D Molecular Therapeutics
4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.
51-200 employees
H1B Sponsorship
4D Molecular Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$702.5MKey Investors
Cystic Fibrosis FoundationViking Global Investors
2025-11-06Post Ipo Equity· $100M
2025-10-13Post Ipo Equity· $7.5M
2024-02-06Post Ipo Equity· $300M
Leadership Team
David Kirn
Co-Founder & CEO
L
Liansheng Zhu
Sr VP Biometrics and Data Quality
Recent News
2026-01-07
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-19
Benzinga.com
2025-12-19
Company data provided by crunchbase