Medical Director

Role Summary

The Medical Director, Ophthalmology will contribute to the design, start-up, execution, analysis, and communication of the clinical studies in Ophthalmology. This highly visible role will collaborate with clinical operations, biometrics, data management, regulatory affairs, CMC, pharmtox, drug safety, key sites/PI communications, commercial, and alliance partners (CRO/CRC and other vendors).

Responsibilities

• Specialization is retinal disease/imaging/gene therapy is required as well as strong Phase III clinical research experience.
• Act as medical monitor in clinical ophthalmology studies with a focus on safety, data review and analysis of emerging data
• Contribute to study related documents including but not limited to study synopsis, protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, and other regulatory submissions and project-related documents. Accountable for the medical content of documents.
• Analyze, interpret, and organize data for presentations and publications
• Interact with external experts to gather input. Organize scientific advisory board meetings and data safety monitoring committee meetings
• Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings
• Ability to communicate with Investigators and research site staff to ensure rigorous and compliant study conduct
• Able and willing to travel
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Qualifications

• Medical Degree (M.D.) with clinical experience
• Clinical residency training in ophthalmology required.
• Experience with retinal disease, retinal imaging, or gene therapy
• 5+ years of experience in clinical research in the pharmaceutical/biotech industry.
• Experience writing clinical research protocols and acting as a medical monitor preferred.
• Experience in multiple phases of clinical research (Phase 1-3) required
• 4 yrs Phase III clinical research experience required
• Effective written and verbal communication skills
• Knowledge of ICH-GCP and FDA regulatory guidelines. Knowledge of international regulatory requirements a plus
• Able to work in a fast-paced, team-based environment; able to multitask and be a self-starter

Additional Requirements

• Travel: 10%
• Physical Activity - Repetitive motions: Making substantial movements (motions) 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).