4D Molecular Therapeutics · 3 months ago
Vice President, Clinical Development, Ophthalmology
United States
Full-time
Remote
Director/Executive
$380K/yr - $433K/yr
10+ years exp4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development.
BiotechnologyGenetics
Responsibilities
Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence throughout study execution
Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review, while maintaining personal accountability for real-time monitoring activities and timely delivery of critical clinical trial outputs
Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc
Provide oversight and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents and other regulatory submissions or documents as appropriate
Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables
Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines
Provide medical leadership for internal audits and regulatory inspections
Assist in preparation of materials for Advisory Board meetings, BOD meetings, etc
Represent 4DMT and Lead interactions and collaborations with potential partners
Represent the Ophthalmology Therapeutic Area with key external stakeholders, including patients and patient advocacy groups, external experts, investors, and the ophthalmic and biotech business communities
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
M.D. Degree
Clinical training in Ophthalmology
Retina fellowship training a plus
Board Certification (or equivalent)
Minimum of 10 years of biopharma industry experience in drug development
Phase 3 experience in retinal disease(s)
Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus
Experience with gene therapy, other areas of Drug Development and commercialization is a plus
Strong interpersonal skills and high emotional coefficient
Highly effective written and verbal communication skills
Excellent analytical, problem-solving and strategic planning skills
Up to date understanding of the ophthalmic competitive landscape with a focus on retina
Prior Clinical Trial experience in Retina
Experience in participating or leading global regulatory interactions
Ability to understand and translate complex data to key messages
Ability to thrive in a fast-paced environment
Proven ability to prioritize effectively
Proven ability to plan and conduct clinical trials ensuring high-quality trial execution and results within established timelines; demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory
Track record of thinking strategically and executing to strategy
Demonstrated success in influencing colleagues and senior leaders in various departments
Experience building and leading teams and driving engagement in a matrixed environment
Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
Able to ensure accountability
Able to manage conflict
Comfortable managing ambiguity
Strong clinical and scientific knowledge of ophthalmology (and retinal disease in particular)
Track record of developing talent
Record of cultivating and managing internal and external cross-functional collaborations
Demonstrates high integrity
Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC
Integrated understanding of FDA, EMA, ICH, and GCP guidelines
Prior interactions with FDA and EMA regulatory agencies is desirable
Company
4D Molecular Therapeutics
4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.
51-200 employees
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
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2025-12-19
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