Vice President, Clinical Development

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 for blinding retinal vascular diseases, offering multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection. The Company’s lead indication for 4D-150 is wet age-related macular degeneration (Phase 3 development) and diabetic macular edema. The second product candidate, 4D-710, 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.

About the role

Reporting to the Chief Medical Officer, the VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines. This role involves spearheading the introduction of intravitreally delivered genetic medicines for the treatment of common causes of irreversible blindness. The VP will serve as the primary point person for medical oversight of clinical studies, including medical monitoring, data review, clinical trial design, protocol development, and drafting key clinical documents such as protocols, CSRs, briefing packages, INDs, NDAs, BLAs, and MAAs.

Responsibilities

• Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence.
• Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review while maintaining accountability for real-time monitoring activities.
• Provide medical leadership for cross-functional internal workstreams, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
• Oversee and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents, and other submissions.
• Collaborate closely with Clinical Operations to ensure clinical trial conduct and adherence to timelines for key deliverables.
• Maintain up-to-date knowledge of compliance, SOPs, ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparing materials for Advisory Board meetings, Board of Directors meetings, and other key presentations.
• Represent 4DMT and lead interactions with potential partners, external experts, investors, and the ophthalmic and biotech communities.
• Engage with key external stakeholders, including patients, patient advocacy groups, and the broader ophthalmology community.
• Travel domestically and internationally as required, approximately 20%.

Qualifications

• MD degree.
• Clinical training in Ophthalmology preferred; Retina fellowship training a plus.
• Board Certification (or equivalent) preferred.
• Minimum of 8 years of biopharma industry experience in drug development.
• Phase 3 ophthalmology experience; retinal disease highly preferred.
• Experience with NDA, BLA, or MAA submissions; drug approval(s) a plus.
• Experience with gene therapy, other areas of drug development, and commercialization is a plus.

Skills

• Strong interpersonal skills and high emotional intelligence.
• 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 highly preferred.
• Ability to translate complex data into key messages.
• Proven ability to thrive in a fast-paced environment and prioritize effectively.
• Demonstrated track record of planning and conducting high-quality clinical trials within established timelines.
• Experience working effectively in cross-functional teams, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
• Experience presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in the US, EU, and APAC.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines; prior interactions with FDA and EMA desirable.
• Track record of strategic thinking and execution.
• Demonstrated success in influencing colleagues and senior leaders across departments.
• Experience building and leading teams in a matrixed environment.
• Attention to detail, internal drive for high-quality work, and passion for achieving team and program goals.
• Proven ability to develop talent.
• High integrity.

Physical Requirements and Working Conditions

• Physical Activity: Repetitive motions of the wrists, hands, and/or fingers (e.g., typing).
• Fingering: Working primarily with fingers (e.g., picking, pinching, typing).
• Talking: Expressing or exchanging ideas by spoken word.
• Physical Requirements: Sedentary work involving exerting up to 10 pounds of force occasionally (e.g., sitting most of the time with occasional walking or standing).
• Working Conditions: Typical office or administrative environment with no substantial exposure to adverse conditions.

Pay

Base salary compensation range: $350,000 – $430,000. The actual salary offered depends on factors such as geographical location, relevant work experience, skills, and years of experience.