Vice President, Clinical Development, Ophthalmology

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October 13

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4D Molecular Therapeutics

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4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

51 - 200 employees

📋 Description

• Reporting to the Chief Medical Officer the VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants for employment