Responsibilities:

• Provide scientific and medical contribution to the design and execution of clinical trials
• Collaborate on, or lead where appropriate, the preparation of clinical study related documents including protocols, clinical study manuals, ICFs, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
• Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies
• Provide support for the medical monitoring and safety oversight of clinical trials in collaboration with the team's medical representatives
• Perform clinical review of data listings and essential study data within generated statistical reports and other data surveillance tools, and partner with Data Management in generating relevant queries
• Contribute to the analysis, interpretation and reporting of clinical studies
• Provide clinical and scientific content and contribute to the overall strategy in regulatory submissions and interactions
• Liaise with clinical operations for study execution related activities, including site selection, site start-up activities, investigator meetings, screening and enrollment planning, protocol amendments, etc
• Support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures
• Support the preparation of internal and external scientific and clinical study related documents, and effectively communicate scientific and medical data results/information
• Contribute to (or lead) targeted research and literature reviews with good judgement on the weight of evidence to support the clinical development strategy
• Contribute to (or lead) specific research efforts to support ongoing clinical programs
• Contribute to the assessments of potential new products or programs

Minimum Requirements:

• A doctoral degree (OD, MD, PharmD, or PhD in life science) required
• A minimum of 5 years of Pharmaceutical/Biotechnology experience
• Experience in cell or gene therapy and ophthalmology is preferred
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Able to work independently
• Strong judgement and decision-making skills
• Intellectual curiosity, flexibility and persistence
• Ability to collaborate cross-functionally and with external stakeholders

Working Environment:

• Full time
• Remote or hybrid can be arranged