Medical Director, Retina Gene Therapy (Hybrid/Remote)

Opus Genetics; Durham (NC); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

Opus Genetics seeks a Medical Director to provide senior medical and scientific leadership across inherited retinal disease clinical programs in a Durham, NC hybrid setting with remote consideration for East Coast candidates.

You will oversee clinical development plans, endpoint strategies, and regulatory submissions, coordinating with Biometrics, Regulatory, and Translational Medicine teams to drive safe, effective therapies.

Qualifications

• MD required for leadership in clinical development.
• Experience in biotechnology or pharmaceutical clinical development.
• Expertise with OCT and microperimetry analysis.
• Strong interpretation of complex clinical data and risk assessment.
• Excellent medical writing, presentation, and communication skills.
• Board eligibility or certification in ophthalmology preferred.

Responsabilités

• Provide medical oversight across clinical studies, including adverse event review, protocol deviations, eligibility questions, safety surveillance, and benefit-risk evaluation.
• Lead clinical development plans, target product profiles, protocol concepts, study design, eligibility criteria, assessment schedules, statistical analysis considerations, and endpoint strategy.
• Lead endpoint development, including selection, clinical rationale, definition, timing, and alignment with program and regulatory strategy.
• Oversee clinical data analysis in partnership with Biometrics and Clinical Operations, including review plans, interim analyses, data-cleaning priorities, interpretation, and communication of results.
• Provide medical input on reading-center selection and oversight, imaging charters, acquisition standards, and adjudication approaches.
• Draft and review clinical and medical documents: protocols, investigator brochures, informed consent materials, clinical study reports, regulatory briefing materials, and scientific presentations.
• Collaborate with Regulatory Affairs on health-authority submissions, meeting preparation, and clinical rationale for development and registration strategies.
• Support investigator selection, site engagement, investigator meetings, and enrollment strategy.
• Coordinate with independent data monitoring committees to support timely data review.
• Work with Translational Medicine and nonclinical colleagues to integrate natural history, biomarker, imaging, and preclinical evidence into clinical strategy.

Connaissances

Clinical development

OCT and microperimetry

Data interpretation

Medical writing

Cross-functional collaboration

GCP knowledge

Formation

MD

Description du poste

Opus Genetics seeks a Medical Director to provide senior medical and scientific leadership across inherited retinal disease clinical programs in a Durham, NC hybrid setting with remote consideration for East Coast candidates.

You will oversee clinical development plans, endpoint strategies, and regulatory submissions, coordinating with Biometrics, Regulatory, and Translational Medicine teams to drive safe, effective therapies.