2 дня назад
Executive Medical Director (Retina Program)
350 000 - 398 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Medical Director (Retina Program) (Ophthalmology/Gene Therapy): Leading the design, execution, and analysis of Phase 1 retina clinical trials and biomarker strategies with an accent on clinical development, medical monitoring, and regulatory documentation. Focus on interpreting clinical data, guiding go/no-go decisions, developing imaging and molecular biomarkers, and supporting IND submissions and early regulatory interactions.
Location: Remote, United States; travel up to 20%
Base salary: $350,000–$398,000 per year
Company
is a late-stage biotechnology company developing disease-targeted genetic medicines, including retinal and pulmonary therapies.
What you will do
- Lead Phase 1 retina clinical trials, including study design, protocol development, dose escalation, safety oversight, execution, and clinical readouts.
- Serve as medical monitor and ensure subject safety, data integrity, and timely trial delivery.
- Lead cross-functional study teams across clinical operations, biometrics, regulatory, safety, CMC, pharmacology, toxicology, and commercial functions.
- Develop and implement biomarker strategies for geographic atrophy and broader retina programs, integrating imaging, molecular, and functional biomarkers.
- Author clinical development plans, protocols, investigator brochures, INDs, clinical study reports, and regulatory responses.
- Lead scientific advisory board meetings and collaborate on program opportunities, risks, and mitigation strategies.
Requirements
- Medical degree; other degrees may be considered with relevant experience.
- Ophthalmology residency training, preferably with retina subspecialty training.
- 10+ years of clinical ophthalmology research experience in the biopharmaceutical industry.
- Experience with medical monitoring and oversight of Phase 1 retina clinical trials and gene therapy clinical studies.
- Experience with Phase 2 and Phase 3 research, NDA/BLA/MAA submission planning, data analysis, interpretation, and medical writing.
- Knowledge of ICH-GCP, FDA, and international regulatory guidelines, with strong written, verbal, and public-speaking skills.
Nice to have
- Board certification or retina fellowship training.
Culture & Benefits
- Remote work arrangement in the United States.
- Sedentary office-based working conditions with occasional travel.
- Equal employment opportunity workplace.
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