Clinical Development Associate
Washington, USA
Listed on 2026-10-27
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Healthcare
Clinical Research, Medical Science
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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
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…
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