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).

• Specialization is retinal disease/imaging/gene therapy is required as well as strong Phase III clinical research experience.

Responsibilities

• 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‚Äôs right to assign or reassign duties and responsibilities to this job at any time

Qualifications

• Education:
  • Medical Degree (M.D.) with clinical experience
  • Clinical residency training in ophthalmology required.
• Experience:
  • 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
• Other Qualifications/Skills:
  • 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

Skills

• Strong analytical and data interpretation abilities
• Excellent scientific communication and collaboration

Education

• Medical Degree (M.D.) with clinical experience
• Clinical residency training in ophthalmology

Additional Requirements

• Travel: 10%
• Physical Requirements and Working Conditions:
  • Repetitive motions of wrists/hands/fingers; typing
  • Sedentary work with occasional lifting up to light weights
  • Not substantially exposed to adverse environmental conditions