Vice President, Clinical Development

The role

The VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines. This person will serve as the primary medical monitor for multiple ophthalmology clinical trials and lead cross-functional internal workstreams.

What you will do

• Serve as the primary medical monitor for multiple ophthalmology clinical trials.
• Direct and mentor a team of medical monitors.
• Provide medical leadership for cross-functional internal workstreams.
• Provide oversight for development plans, study protocols, and regulatory submissions.
• Collaborate with Clinical Operations regarding trial conduct and timelines.
• Adhere to compliance, SOPs, ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board and BOD meetings.
• Represent 4DMT and lead interactions with potential partners.
• Represent the Ophthalmology Therapeutic Area with external stakeholders.

Required qualifications

• MD Degree
• Minimum of 8 years of biopharma industry experience in drug development.
• Experience with NDA, BLA or MAA submission(s).
• 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.
• 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.
• Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC.

Nice to have

• Clinical training in Ophthalmology
• Retina fellowship training
• Board Certification (or equivalent)
• Phase 3 ophthalmology experience; retinal disease highly preferred.
• Drug approval(s) a plus.
• Experience with gene therapy, other areas of Drug Development and commercialization is a plus.
• Prior clinical trial experience in retina highly preferred.
• Prior interactions with FDA and EMA regulatory agencies is desirable.

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed for the treatment of blinding retinal vascular diseases.