AD, Clinical Operations (Contract)
Core
Associate Director leading implementation, execution, and oversight of clinical trials for late-stage ophthalmology and genetic medicine programs.
Role type
Senior IC Clinical Operations Director (Contract)
Builds
Clinical trial programs for 4D-150 (wet AMD, diabetic macular edema) and 4D-710 (cystic fibrosis)
Domain
Biotechnology / Clinical Development / Ophthalmology / Genetics
Required skills
Clinical trial execution, budget management, vendor governance, cross-functional leadership, GCP/ICH compliance, risk mitigation, protocol development, team mentoring
Preferred skills
Advanced degree (M.S./M.A., MPH, MBA), Clinical Research certification, ophthalmology trial experience, late-phase trial experience
Technologies
Clinicaltrials.gov, GCP, ICH Guidelines, FDA regulations
Responsibilities
Develop and manage clinical programs in coordination with cross-functional teams; oversee day-to-day activities of Clinical Trial Operations and Data Management groups; manage clinical vendor outsourcing strategy and governance; ensure trials are inspection-ready; collaborate on regulatory submissions; develop and maintain clinical SOPs; address escalated study issues and risk mitigation plans.
Seniority
Senior, hands-on IC with managerial oversight