Medical Director

🔥 52 minutes ago

🇺🇸 United States – Remote

💵 $278k - $310k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

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.

📋 Description

• Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation. • Serve as medical monitor for clinical studies, ensuring patient safety and data integrity. • Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions. • Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success. • Engage with external experts, organize advisory boards, and contribute to scientific and medical communications. • Identify and mitigate clinical and programmatic risks. • Support portfolio development and evaluation of new clinical opportunities. • Represent the company in regulatory and scientific forums as needed.

🎯 Requirements

• Medical Degree (M.D.), OD, PhD, PharmD or equivalent • Residency training in Ophthalmology with a preference for subspecialty training in retina • Board certification a plus • Retina fellowship training a plus • 5+ years of clinical ophthalmology research in the biopharmaceutical industry • Experience with Phase 3 retina clinical trials • Experience with gene therapy a plus • Experience in other phases (Phase 1, 2, 4) of clinical research a plus. • Experience with NDA/BLA/MAA submission a plus. • Experience writing clinical research protocols and acting as a medical monitor • Experience in data analysis, data interpretation, and medical writing • Knowledge of ICH-GCP and FDA regulatory guidelines. • Knowledge of international regulatory guidelines a plus. • Effective written and verbal communication skills, including public speaking.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities