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GENERAL SUMMARY:The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus on retina programs. This role provides strategic and operational clinical leadership across cross-functional study teams and serves as a key medical expert internally and externally.
MAJOR DUTIES & RESPONSIBILITIES:Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation.
Serve as medical monitor for clinical studies, ensuring patient safety and data integrity.
Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions.
Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success.
Engage with external experts, organize advisory boards, and contribute to scientific and medical communications.
Identify and mitigate clinical and programmatic risks.
Support portfolio development and evaluation of new clinical opportunities.
Represent the company in regulatory and scientific forums as needed.
QUALIFICATIONS:Education:
- Medical Degree (M.D.), OD, PhD, PharmD or equivalent
- 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.
- Experience writing clinical research protocols and acting as a medical monitor
- Experience in data analysis, data interpretation, and medical writing
Other Qualifications/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
Travel: 15%
Physical Requirements and Working Conditions:
- 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).
Base salary compensation range: $278,000 - 310,000
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.
