Executive Medical Director, (Retina Program)
Jobgether · United States · 1 wk ago
RemoteRemoteHealthcare$350k–$398k/yrFull-time
Accountabilities
- Serve as the clinical and scientific leader for retinal disease development programs, overseeing clinical strategy, trial execution, and medical decision-making.
- Work closely with multidisciplinary teams and external experts to ensure programs are scientifically rigorous, operationally successful, and aligned with regulatory expectations.
- Lead Phase 1 retina clinical development programs, including trial design, protocol development, dose escalation strategies, safety oversight, and clinical execution.
- Provide medical monitoring and oversight to ensure patient safety, data integrity, and high-quality clinical outcomes.
- Lead cross-functional clinical study teams across clinical operations, biometrics, regulatory affairs, CMC, pharmacology, toxicology, safety, and commercial functions.
- Drive interpretation of clinical data, identify early signals, and provide recommendations regarding program advancement and strategic decisions.
- Develop and implement biomarker strategies for retinal disease programs, including imaging, molecular, and functional biomarker approaches.
- Partner with research and translational teams to align biomarkers with mechanisms of action, dose selection, endpoints, and regulatory strategies.
- Author and oversee key clinical and regulatory documents, including development plans, protocols, investigator brochures, IND materials, clinical study reports, and regulatory responses.
- Support regulatory interactions, including preparation for health authority meetings and submissions.
- Organize scientific advisory boards and engage with external experts to gather insights and strengthen development strategies.
- Collaborate with leadership teams to identify opportunities, assess program risks, and develop mitigation strategies.
- Mentor and provide scientific leadership to internal teams while fostering collaboration across functions.
Requirements
- An experienced ophthalmology and clinical development leader with deep expertise in retinal diseases, biopharmaceutical research, and early-stage clinical trials.
- Strong scientific judgment, regulatory knowledge, and the ability to influence cross-functional teams in a complex, innovative environment.
- A medical degree (M.D.) or equivalent advanced medical qualification with relevant experience.
- Residency training in Ophthalmology, with retina subspecialty training strongly preferred.
- Board certification and/or retina fellowship training considered a plus.
- 10+ years of clinical ophthalmology research experience within the biopharmaceutical industry.
- Proven experience leading medical monitoring and oversight for Phase 1 retina clinical trials.
- Experience supporting or leading gene therapy clinical studies preferred.
- Additional experience across Phase 2 and Phase 3 clinical development programs is a plus.
- Experience with NDA, BLA, or MAA submission planning and execution.
- Strong background in clinical data analysis, interpretation, and medical writing.
- Knowledge of ICH-GCP standards, FDA regulations, and international regulatory guidelines.
- Demonstrated ability to lead multidisciplinary teams and influence internal and external stakeholders.
- Excellent written, verbal, and presentation skills, including the ability to communicate complex scientific concepts clearly.
- Ability to travel up to 20%.
Benefits
- Competitive base salary range of $350,000 - $398,000 USD, depending on experience, skills, location, and qualifications.
- Opportunity to contribute to the development of innovative therapies addressing serious retinal diseases.
- Remote work flexibility within the United States.
- Leadership role within a growing biotechnology organization focused on advancing breakthrough science.
- Collaboration with multidisciplinary experts across research, clinical development, regulatory, and commercial teams.
- Comprehensive benefits package, including health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off.
- Opportunity to participate in a mission-driven environment focused on improving patient outcomes.