Vice President, Clinical Development

4DMT is a late-stage biotechnology company advancing durable and disease-targeted therapeutics. Its lead product candidate, 4D-150, is designed for sustained delivery of anti-VEGF therapies for retinal vascular diseases, including wet age-related macular degeneration and diabetic macular edema. Its second product candidate, 4D-710, is a genetic medicine for cystic fibrosis.

General Summary:

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.

The VP, Clinical Development will provide medical oversight of clinical studies, review and interpret clinical trial data, design clinical trials, develop protocols, and draft key clinical and regulatory documents. This role is responsible for timely execution of deliverables in collaboration with internal and external partners.

Responsibilities:

• Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing oversight of patient safety, data integrity, and protocol adherence.
• Direct and mentor a team of medical monitors.
• Provide medical leadership for cross-functional workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
• Oversee development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents, and other submissions.
• Collaborate with Clinical Operations and oversee clinical trial conduct and timelines.
• Maintain compliance with SOPs, ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparing materials for Advisory Board and Board of Directors meetings.
• Represent 4DMT in interactions with potential partners.
• Represent the Ophthalmology Therapeutic Area with external stakeholders, including patients, advocacy groups, experts, investors, and industry communities.
• Travel domestically and internationally as required, approximately 20%.

Qualifications:

Education:

• MD Degree
• Clinical training in Ophthalmology preferred
• Retina fellowship training a plus
• Board Certification or equivalent preferred

Experience:

• 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.
• Experience with gene therapy, drug development, and commercialization is a plus.

Skills:

• Strong interpersonal, written, verbal communication, analytical, problem-solving, and strategic planning skills.
• Understanding of the ophthalmic competitive landscape, particularly retina.
• Clinical trial experience in retina.
• Ability to understand and translate complex data into key messages.
• Ability to prioritize, plan, and conduct high-quality clinical trials within established timelines.
• Experience working in cross-functional teams and presenting to ophthalmic communities and regulatory authorities in the US, EU, and APAC.
• Understanding of FDA, EMA, ICH, and GCP guidelines.
• Strategic thinking and execution.
• Ability to influence colleagues and senior leaders.
• Experience building and leading teams in a matrixed environment.
• Attention to detail, integrity, and ability to develop talent.

Physical Requirements and Working Conditions:

• Sedentary work involving sitting most of the time and occasional lifting, carrying, pushing, or pulling of up to 10 pounds.
• Repetitive wrist, hand, and finger movements, including typing.
• Talking and exchanging ideas by spoken word.
• Work is generally performed in typical office or administrative conditions.

4DMT provides equal employment opportunities to all employees and applicants without regard to protected characteristics.