Medical Director (Remote)

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GENERAL SUMMARY:

Reporting to the Therapeutic Area Head-Ophthalmology, the 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
• Serves as medical monitor on clinical studies.
• Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input.
• 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
• Board certification a plus

Experience:

• 3+ years of clinical ophthalmology research in the biopharmaceutical industry
• Experience with retina clinical trials
• Experience with gene therapy a plus
• Experience in other phases (Phase 1, 2, 4) of clinical research a plus.

Skills:

• Experience writing clinical research protocols and acting as a medical monitor
• Experience in data analysis, data interpretation, and medical writing
• Effective written and verbal communication skills, including public speaking
• Knowledge of ICH-GCP and FDA regulatory guidelines.
• Knowledge of international regulatory guidelines a plus.

Other:

• Ability to travel 15% (3 days/month)
• Remote/hybrid acceptable but Local/Hybrid preferred

Compensation range: $268,000k/yr - $345,000k/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities