Senior Medical Director - Ophthalmology (Retina)

GENERAL SUMMARY:

Reporting to the SVP Therapeutic Area Head-Ophthalmology, 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:

• 5+ 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.

Skills:

• Knowledge of ICH-GCP and FDA regulatory guidelines.

• Knowledge of international regulatory guidelines a plus.

• 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

• Ability to travel 15% (3 days/month)

• Remote/hybrid acceptable but Local/Hybrid preferred

Compensation range:

Outside of Bay Area: $301k/yr - $365k/yr

Bay Area range: $347k/yr - $370k/yr

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