Description

You will partner with cross-functional teams to develop innovative study designs and clinical trial protocols for ophthalmology gene therapy programs, provide clinical support for study conduct, and contribute to the preparation of regulatory filings and scientific publications. Your work will help advance novel treatments for blinding retinal diseases.

Requirements

• MS in biological/health science required; OD, PhD, or PharmD preferred
• MS with 12+ years Clinical science experience, or OD/PhD/PharmD with 8+ years experience including 5+ years drug development with ophthalmology experience, preferably in retinal disease
• Advanced experience in clinical trial design, implementation, regulatory document preparation and statistics
• Phase 3 experience, retinal gene therapy experience, NDA/BLA/MAA submission experience
• Ability to interpret, analyze, and present clinical data
• Thorough understanding of drug development process
• Broad understanding of functional areas including preclinical, regulatory, pharmacovigilance, data sciences, and clinical operations
• Excellent communication and writing skills
• Well-organized with ability to manage multiple projects in a fast-paced environment
• Good leadership and management skills

Responsibilities

• Partner with cross-functional program team members to support development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials
• Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates
• Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials
• Prepare and communicate clear overviews of trial results; identify issues related to study conduct and/or subject safety and collaborate to develop solutions
• Interact with internal and external stakeholders in support of program-level strategy and clinical trial objectives
• Act as recognized clinical expert for assigned programs; contribute to preparation of medical and scientific data for publications, presentations, and study milestones
• Serve as a point of contact for clinical operations personnel, clinical trial sites and CROs for clinical science questions
• Maintain knowledge of ICH-GCP and FDA IND regulations and procedures; contribute to authoring clinical documents and regulatory filings