Senior Medical Director

Summary

Join 4DMT, a clinical-stage biotherapeutics company, as a Senior Medical Director to lead the design, execution, and analysis of clinical trials in Ophthalmology. You will provide clinical leadership to multidisciplinary study teams, lead scientific advisory board meetings, and serve as a medical monitor on clinical studies. This role requires expertise in clinical ophthalmology research, specifically in retina, and experience with Phase 3 clinical trials. The successful candidate will have a Medical Degree (M.D.), residency training in Ophthalmology, and 8+ years of relevant experience. The position offers a competitive salary and the opportunity to contribute to the development of innovative genetic medicines.

Requirements

• Medical Degree (M.D.)
• Residency training in Ophthalmology with a preference for subspecialty training in retina
• 8+ years of clinical ophthalmology research in the biopharmaceutical industry
• Experience with Phase 3 retina clinical trials
• 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
• Effective written and verbal communication skills, including public speaking

Responsibilities

• Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners
• Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts
• Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input
• Serves as medical monitor on clinical studies
• Serves as the primary clinical author of development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory submissions / correspondence, and project-related documents. Accountable for the accuracy of all medical content of such documents
• Works with the research organization and the portfolio management team to identify and support new project opportunities
• Collaborates to identify program risks, and to create and implement mitigation strategies
• Other duties as assigned

Preferred Qualifications

• Board certification
• Retina fellowship training
• Experience with gene therapy
• Experience in other phases (Phase 1, 2, 4) of clinical research
• Experience with NDA/BLA/MAA submission
• Knowledge of international regulatory guidelines

Benefits

Base salary compensation range: $315,000/yr - $390,000/yr