Note: The job is a remote job and is open to candidates in USA. Aurion Biotech is a clinical-stage biotechnology company developing innovative regenerative therapies to restore vision, including an allogeneic cell therapy for corneal edema. The Senior Clinical Operations Scientist serves as a scientific expert and bridge to clinical development for ophthalmology programs, supporting protocol development, study execution, data interpretation, regulatory interactions, and dissemination of scientific findings.
Responsibilities
- Reports to Clinical Operations to serve as a clinical scientist who is a bridging partner to clinical development for one or more ophthalmology clinical programs
- Support study startup, conduct, monitoring, closeout, and inspection readiness activities
- Participate in investigator meetings, data review meetings, and cross-functional clinical trial team meetings
- Supports site feasibility assessments and provide scientific guidance to investigators and study sites
- Identifies and mitigate scientific and clinical risks associated with study execution
- Contributes to the development of Clinical Development Plans, Target Product Profiles, and overall development strategies
- Translate development objectives into clinical study designs and operationally feasible protocols
- Author and review study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical study documents
- Provides scientific expertise supporting ophthalmic assessments, endpoint selection, imaging strategies, and study conduct
- Supports ongoing medical and scientific review of clinical trial data as assigned
- Collaborates with Biostatistics and Data Management to ensure data quality and integrity
- Supports analysis of emerging safety and efficacy data with guidance from the clinical development team to support program decision-making
- Interpret clinical study results and prepare scientific summaries and presentations for internal governance committees
- Contribute to regulatory submissions including INDs, CTAs, briefing packages, annual reports, and responses to regulatory authority questions
- Ensure studies are conducted in compliance with ICH-GCP, applicable regulations, internal SOPs, and ethical standards
- Contribute to abstracts, manuscripts, posters, and presentations for scientific congresses and peer-reviewed journals
- Develop and maintain relationships with key opinion leaders, investigators, and scientific advisors
- Supports and participates in scientific advisory boards and investigator meetings as needed
- Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality Assurance, and external vendors
- Support preparation for regulatory inspections and audits
- Provide scientific mentorship and guidance to junior clinical scientists and study team members
- Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs
- Performs other duties as assigned by clinical scientific operations to support clinical trials
Skills
- Candidates with a Bachelor's degree and 10+ years of clinical research or clinical development experience will also be considered
- Prior experience supporting late-stage (Phase 2/3) clinical programs and leading scientific aspects of clinical studies is required, experience in ophthalmology preferred
- Familiarity with study start-up, data cleaning, closeout, and inspection readiness processes
- Working knowledge of ICH/GCP guidelines and clinical trial processes
- Strong organizational and time management skills; detail-oriented and able to manage multiple tasks
- Proficient in Microsoft Office (Word, Excel, PowerPoint); experience with data visualization tools, TMF, EDC, and other clinical trial systems
- Strong interpersonal and communication skills, both written and verbal
- Ability to work effectively in a team environment and across global teams and vendors
- Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders
- Demonstrated cultural agility, integrity, and a passion for advancing transformative science
- Ability to travel up to 15%, candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support
- A strong alignment with, and commitment to, Aurion Biotech's mission, vision, and core values
- Advanced degree (PharmD, PhD, OD, MS, MPH, or related scientific discipline) in life sciences, nursing, or related field with 7+ years of clinical research or clinical development experience (preferred)
- Prior experience supporting late-stage (Phase 2/3) clinical programs and leading scientific aspects of clinical studies is required, experience in ophthalmology preferred
Benefits
- Remote (WA or MA preferred)
- Full health insurance for employees and their families
- 401(k) matching
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid parking
- Subsidized commuter passes
- In-office catered lunches
- Team events
- Community projects
Company Overview
Company H1B Sponsorship