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

• 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
• Experience:
• 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: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).