JOB TITLE: Senior Clinical Operations ScientistLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA.
REPORTS TO: Director, Scientific Operations
SALARY RANGE:$158,000 to $188,000Aurion Biotech is seeking a Senior Clinical Operations Scientist. The Sr. Clinical Operations Scientist serves as a scientific expert for assigned studies and programs, contributing to protocol development, data review, interpretation of clinical outcomes, regulatory interactions, and dissemination of scientific findings. In addition, the Sr. Clinical Operations Scientist supports the execution of Aurion clinical trials.
KEY 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
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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)
- 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.
REQUIRED SKILLS AND ABILITIES- 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.
Salary Description
$158,000 to $188,000
