Executive Medical Director

Role Summary

Executive Medical Director responsible 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

• Education:
  • Medical Degree (M.D.)
  • Residency training in Ophthalmology with a preference for subspecialty training in retina
  • Board certification/retina fellowship training are a plus
• Experience:
  • 9+ years of clinical ophthalmology research in the biopharmaceutical industry
  • Experience with medical monitoring and oversight of Phase 3 retina clinical trials
  • Experience with gene therapy clinical studies
  • Experience in other phases (Phase 1, 2, 4) of clinical research
  • Experience with NDA/BLA/MAA submission planning and execution
  • Experience in data analysis, data interpretation, and medical writing
• Other Qualifications/Skills:
  • Knowledge of ICH-GCP and FDA regulatory guidelines
  • Knowledge of international regulatory guidelines
  • Effective written and verbal communication skills, including public speaking

Skills

• Clinical leadership
• Medical monitoring
• Regulatory writing and submissions
• Collaboration with cross-functional teams
• Risk identification and mitigation

Education

• Medical Degree (M.D.)

Additional Requirements

• Travel: up to 20%
• Physical Requirements and Working Conditions: See description notes on activity and sedentary work