Clinical Development Associate

Aurion Biotech; Washington; À distance; USD 92 000 - 120 000; Plein temps

Résumé du poste

Aurion Biotech is hiring a Clinical Development Associate for a fully remote US role, with WA or MA preferred. The position supports day-to-day clinical trial execution, safety reviews, data tracking, and cross-functional collaboration to advance clinical programs.

The ideal candidate has 1–3 years in clinical research, a strong ophthalmology trial background, and familiarity with ICH-GCP. Expect collaboration across Regulatory, Biometrics, and Clinical Operations to drive study success.

Qualifications

• Strong background in ophthalmology and trial data interpretation.
• 1–3 years in clinical research across sponsor/CRO/academic.
• Familiarity with study start-up, site maintenance, closeout, and inspections.
• Knowledge of ICH/GCP guidelines and trial processes.
• Excellent organizational and communication skills.

Responsabilités

• Support the clinical development team with ongoing scientific and medical oversight and support throughout study startup, enrollment, conduct, database lock, and study closeout.
• Support Medical Monitoring activities and contribute to patient cleaning activities, including assisting with medical monitor query management.
• Identify clinical risks and proactively help develop mitigation strategies.
• Support the clinical scientist with development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents.
• Collaborate with the clinical scientist to help address protocol questions, eligibility determinations, deviations, and study conduct challenges.
• Ensure clinical studies are conducted in accordance with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs.
• Partner with Biometrics and/or Data Management to help develop data review plans and ensure data quality.
• Support ongoing review of clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data.
• Assist members of clinical development with contribution to regulatory meeting preparation and interactions with global health authorities, as assigned.
• Support preparation of briefing documents, responses to agency questions, and submission documents, as assigned.
• Assist with the contribution of scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications.
• Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, and external 3rd party vendors including CRO partners and imaging centers.
• Support inspection readiness activities and participate in audits and regulatory inspections.
• Contribute to continuous process improvement initiatives within Clinical Development.
• Support a collaborative, high-performance culture aligned with Aurion's mission and values.

Connaissances

Ophthalmology trials

Clinical research

Regulatory knowledge

Team collaboration

MS Office

Formation

BSc in life sciences

Outils

TMF

EDC systems

Microsoft Office

Description du poste

All Jobs > Clinical Development Associate

Fully Remote US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, WI, IN applicants only

Description

JOB TITLE: Clinical Development Associate

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, WI, MS or WA.

REPORTS TO: Director, Clinical Science

SALARY RANGE: $92,000 to $120,000

ABOUT THE POSITION

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead 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 Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and has advanced into Phase 3 clinical trials in 2026. Aurion operates as a separate entity with full support from Alcon.

The Clinical Development Associate will support the clinical development team with day-to-day clinical trial execution, including data and safety review, safety and efficacy metric tracking, and internal and external cross-functional collaboration to help advance Aurion Biotech's clinical programs.

KEY RESPONSIBILITIES

• Support the clinical development team with ongoing scientific and medical oversight and support throughout study startup, enrollment, conduct, database lock, and study closeout
• Support Medical Monitoring activities and contribute to patient cleaning activities, including assisting with medical monitor query management
• Identify clinical risks and proactively help develop mitigation strategies
• Support the clinical scientist with development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents
• Collaborate with the clinical scientist to help address protocol questions, eligibility determinations, deviations, and study conduct challenges
• Ensure clinical studies are conducted in accordance with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs
• Partner with Biometrics and/or Data Management to help develop data review plans and ensure data quality
• Support ongoing review of clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data
• Assist members of clinical development with contribution to regulatory meeting preparation and interactions with global health authorities, as assigned
• Support preparation of briefing documents, responses to agency questions, and submission documents, as assigned
• Assist with the contribution of scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
• Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, and external 3rd party vendors including CRO partners and imaging centers
• Support inspection readiness activities and participate in audits and regulatory inspections
• Contribute to continuous process improvement initiatives within Clinical Development
• Support a collaborative, high-performance culture aligned with Aurion's mission and values

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The 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 granted regulatory approval from Japan's PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

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

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

LIFE AT AURION BIOTECH

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

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

Requirements

QUALIFICATIONS AND EDUCATION

To 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.

• A strong background in ophthalmology, ophthalmology clinical trials, and interpretation of ophthalmology data including visual acuity procedures and image collection
• Bachelor's degree in life sciences, nursing, or related field preferred
• 1-3 years of experience in clinical research, including exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 2 or 3 clinical trials.
• Familiarity with study start-up, site maintenance, 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 TMF, EDC, and other clinical trial systems a plus.
• 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.