Vice President, Late Stage Ophthalmology - DME

Overview

Attention recruitment agencies: All agency inquiries are vetted through 4

DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4

DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4

DMT in the future.

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DMT 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 forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections.

The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which 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.

Reporting to the Chief Medical Officer the VP Late Stage Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development. We seek an experienced physician to play a critical role at 4

DMT as we spearhead the introduction of the first intravitreally delivered genetic medicines for the treatment of the most common causes of irreversible blindness. The VP, Late Stage Ophthalmology will be the primary point person for medical oversight of clinical studies with responsibilities to include medical monitoring, review and interpretation of clinical trial data, clinical trial design, protocol development, and drafting of key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc.

This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.

• 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 work streams 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 4
  
  DMT 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.
• Travel domestically and internationally as required ~20%.

Education:

• M.D. Degree
• Clinical training in Ophthalmology
• Retina fellowship training a plus
• Board Certification (or equivalent)

Experience:

• Minimum of 8 years of biopharma industry experience in drug development
• Phase 3 experience in retinal disease(s); diabetic eye disease highly preferred
• Experien…