Sr. Medical Director

Role Summary

The Senior Medical Director is accountable for the design, execution, and analysis of clinical trials in the Ophthalmology Therapeutic Area.

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

Qualifications

• Medical Degree (M.D.)
• Residency training in Ophthalmology with a preference for subspecialty training in retina
• Board certification a plus
• Retina fellowship training a plus
• 8+ 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

Skills

• Knowledge of ICH-GCP and FDA regulatory guidelines
• Knowledge of international regulatory guidelines a plus
• Effective written and verbal communication skills, including public speaking

Education

• Medical Degree (M.D.)
• Residency training in Ophthalmology with a preference for subspecialty training in retina
• Board certification a plus
• Retina fellowship training a plus

Additional Requirements

• Travel: 15% (3 days/month)
• Physical Requirements and Working Conditions:
  • Physical Activity - Repetitive motions: Making substantial movements of the wrists, hands, and/or fingers; Fingering; Talking
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally; mostly sedentary
  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions