Clinical Scientist, Ophthalmology

Main Responsibilities
Clinical Study Support:
- Provide scientific support for ophthalmology study(ies) by operationalizing the medical validation/review plan (reports and trackers)
- Support design and execution of multiple ophthalmology clinical studies
- Perform clinical review and analysis of data listings, patient profiles, and essential study data; partner with Data Management on queries
- Participate in CRF design, review CRF design and completion instructions
- Support CRD and Study Team with study start-up, site opening, enrollment monitoring, and support
Documentation & Regulatory:
- Prepare/review submission and study documents (e.g., protocols, informed consent, benefit-risk assessments, study plans/reports, trial disclosure)
- Support key clinical document preparation for clinical trials
- Support CRD with medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
- Support regulatory document filing and archiving
Data Management & Quality:
- Contribute to centralized monitoring strategy consistent with planned statistical analysis
- Support study data validation and clinical case review (including safety events)
- Ensure quality and updates of study documents and CRF adequacy with protocols/amendments
- Document data collection needs quantitatively/qualitatively
Committee & Stakeholder Management:
- Support preparation and conduct of Study Committees (e.g., IDMC); support Steering/Data Monitoring/Adjudication committees
- Participate in medical information training with Study Team/monitoring team
Strategic & Scientific Contribution:
- Maintain ophthalmology scientific/technical expertise; evaluate literature and provide clinical landscape/benchmarks; build collaborations
- Endorse CRD decisions independently
Project Management:
- Assess/provide study support cost elements; plan and manage timelines
Qualifications
- Master’s required (Biomedical/Life/Pharma Sciences or related); PhD/PharmD/MD preferred
- 3+ years industry experience in clinical research and/or drug development
- Required: ophthalmology clinical trial experience
Required Skills
- Knowledge of data collection/flow/validation through analysis; data-driven, risk-managed medical review practices
- Digital/data-oriented mindset; proficient clinical literature interpretation
- Experience supporting clinical trial preparation/execution
- Basic statistical principles for analysis/interpretation/clinical relevance; translational medicine and biomarkers
- Ability to collaborate globally, communicate clearly; leadership/presentation skills; quality-focused, autonomous, proactive issue management
Preferred Qualifications
- Gene therapy/novel ophthalmology modalities; familiarity with retinal diseases (e.g., AMD, geographic atrophy)
- Experience with audit responses and regulatory inspections