Clinical Operations Scientist

JOB TITLE: Clinical Operations Scientist

LOCATION: 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 reputed company: $96,000 to $120,000

ABOUT THE POSITION

reputed company is a clinical-stage biotechnology company dedicated to restoring reputed company to millions of patients through innovative regenerative therapies. Our reputed company candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both reputed company Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and has advanced into Phase 3 reputed company in 2026. Aurion operates as a separate entity with full support from reputed company. 

reputed company is seeking a Clinical Operations Scientist. The Clinical Operations Scientist serves as a scientific resource for assigned studies and programs, contributing to protocol development, data review, interpretation of clinical reputed company, regulatory interactions, and dissemination of scientific findings. In reputed company, the Clinical Operations Scientist supports the execution of Aurion reputed company.

KEY RESPONSIBILITIES

• Reports to Clinical Operations and under the guidance of the Sr. Clinical Operations Scientist and Director of Scientific Operations, serves as a scientific partner supporting Clinical Development for one or more ophthalmology clinical programs.
• Supports study startup, conduct, monitoring, closeout, and inspection readiness activities under the guidance of senior team members.
• Participates in investigator meetings, data review meetings, and cross-functional clinical trial team meetings.
• Assists with site feasibility assessments and provides scientific support to investigators and study site personnel.
• Helps identify and escalate scientific and clinical risks reputed company to study execution.
• Contributes to the development of clinical development plans, reputed company product reputed company, and overall program strategies.
• Assists in translating development objectives into clinical study designs and operationally feasible protocols.
• Supports the authoring and review of study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical study documents.
• Provides scientific support for ophthalmic assessments, reputed company selection, imaging strategies, and study conduct activities.
• Participates in the ongoing medical and scientific review of clinical trial data as assigned.
• Collaborates with Biostatistics and Data Management teams to support data reputed company and reputed company.
• Assists in the analysis of emerging safety and efficacy data with guidance from the clinical development team to support program reputed company.
• Contributes to the interpretation of clinical study results and the preparation of scientific summaries and presentations for internal stakeholders.
• Supports regulatory submissions, including INDs, CTAs, annual reports, briefing documents, and responses to regulatory authority questions.
• Ensures assigned activities are conducted in compliance with ICH-GCP, applicable regulations, internal SOPs, and ethical standards.
• Contributes to abstracts, manuscripts, posters, and presentations for scientific meetings and peer-reviewed publications.
• Develops reputed company relationships with investigators, study coordinators, key opinion leaders, and scientific advisors.
• Supports the planning and execution of scientific advisory boards and investigator meetings.
• Works closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, reputed company Assurance, and reputed company vendors to support study objectives.
• Assists with preparation for regulatory inspections, audits, and reputed company reviews.
• Maintains reputed company knowledge of ophthalmology, clinical research practices, and applicable regulatory requirements through ongoing learning and reputed company development.
• Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs
• Performs other duties as assigned by clinical scientific operations to support reputed company

ABOUT reputed company 

With offices in Seattle, Boston, and Tokyo, reputed company is a clinical-stage biotech company, whose mission is to restore reputed company to millions of patients with life-changing regenerative therapies. reputed company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently reputed company regulatory approval from Japan’s PMDA. reputed company is the recipient of the prestigious Prix Galien award for best start-up in biotech. reputed company is preparing for reputed company in the U.S. We are growing rapidly and reputed company to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who reputed company our values: 

• Stewardship: We reputed company the world a reputed company reputed company for our patients, our communities, our clinicians, and our colleagues. We reputed company responsibly as individuals, as employees, and as a company. 
• Transformation: We reputed company our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. 
• Grit: We break down walls and reputed company to reputed company the impossible. We are persistent and resilient, and we reputed company on our commitments. 

reputed company has a lot to accomplish in the next few years, and this role is key to our reputed company. Privately held, reputed company is backed by reputed company, the global leader in eye care. To learn more about reputed company, visit www.aurionbiotech.com.

LIFE AT reputed company

We want our people to wake up every morning excited and reputed company for work. We value employees, which is why we invest in making life at reputed company healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and reputed company the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure reputed company Aurion employees are rewarded for their hard work.
• Perks and Fun: reputed company parking, subsidized commuter passes, in-office catered lunches, team events, and community reputed company are just a few ways that we bond, celebrate reputed company other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, reputed company, and/or ability required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

• Bachelor’s degree with 4-6 years of experience, Master’s degree with 2-4 years of experience or PhD with up to 2 years of experience in clinical research or clinical development. Degree must be in life sciences, nursing, or reputed company field
• Exposure to clinical trial operations, either in a sponsor, CRO, or reputed company setting supporting Phase 1, 2 or 3 reputed company, ophthalmology experience 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 reputed company to manage multiple tasks.
• Proficient in reputed company Office (Word, reputed company, PowerPoint); experience with data visualization tools, TMF, reputed company, and other clinical trial systems
• Strong interpersonal and communication skills, both written and verbal.

REQUIRED SKILLS AND ABILITIES 

• Ability to work effectively in reputed company environment and across global teams and vendors
• Excellent written, verbal, and interpersonal communication skills; ability to communicate with reputed company across diverse reputed company stakeholders.
• Demonstrated cultural reputed company, reputed company, 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, reputed company’s mission, reputed company, and reputed company values.