Aurion Biotech

Clinical Research

• Serve as scientific lead for one or more ophthalmology clinical programs
• Contribute to clinical strategy and clinical development plans
• Translate scientific and medical objectives into operationally feasible clinical trial designs
• Identify clinical risks and develop mitigation strategies
• Lead or support development of study protocols, amendments, informed consent documents, case report forms, and other study documents
• Support site feasibility and investigator selection
• Provide scientific oversight throughout study startup, enrollment, conduct, database lock, and closeout
• Address protocol questions, eligibility determinations, deviations, and study conduct challenges with Clinical Operations
• Support Medical Monitoring and patient cleaning activities
• Participate in investigator, study team, safety/data review, vendor, and scientific advisory board meetings
• Ensure studies comply with protocols, ICH-GCP, regulations, and Aurion SOPs
• Partner with Biometrics and Data Management on data review plans and data quality
• Review clinical, efficacy, safety, imaging, biomarker, and pharmacokinetic data
• Interpret emerging study results and provide clinical insights
• Contribute to regulatory meeting preparation and interactions with global health authorities
• Support briefing documents, agency responses, and submission documents
• Contribute scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
• Lead or support clinical study reports, abstracts, posters, manuscripts, and scientific presentations
• Support publication strategy and dissemination of clinical data
• Present study findings to senior leadership, investigators, advisory boards, and scientific audiences
• Partner with internal functions and external CRO, vendor, and imaging-center partners
• Develop relationships with investigators, key opinion leaders, and scientific advisors
• Support inspection readiness and participate in audits and regulatory inspections
• Contribute to process improvement, Clinical Science processes, standards, and best practices
• Provide scientific mentorship to Clinical Scientists and cross-functional team members
• Support a collaborative, high-performance culture aligned with Aurion’s mission and values

Senior Clinical Scientist

Business Operations

• Provide strategic, technical, operational, and business leadership across the Manufacturing organization
• Serve as the strategic and operational integrator for Manufacturing
• Partner across External Manufacturing, MSAT, Supply Chain, Quality, Regulatory, Finance, Legal, and external manufacturing partners
• Develop manufacturing strategies and scenarios for how, where, when, and with what resources manufacturing activities are executed
• Own the Manufacturing team book of work, detailed timelines/smartsheets, integrating technical milestones, dependencies, budgets, and external commitments
• Drive portfolio prioritization and execution
• Lead Manufacturing SOW, contract, budget, PO, and invoice management
• Translate technical strategies into clear scopes, deliverables, schedules, financial commitments, and business arrangements
• Support Manufacturing leadership and technical leads to develop integrated late-stage, commercialization, commercial manufacturing, and operational project timelines and dependencies at site
• Develop risk-based manufacturing scenarios and contingency plans
• Lead commercialization and manufacturing network planning across sites, including capacity, sourcing, redundancy, business continuity, cross-site integration, CDMO strategy, and major lifecycle transitions
• Support the company as it advances through late-stage development, BLA submission, commercialization, commercial launch, and lifecycle management

Senior Clinical Scientist

Associate Director, Manufacturing Business Operations – Strategy