Associate Director, Clinical Operations

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $179k - $210k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Character Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

🔥 Funding within the last year

💰 $17M Series B - Character Biosciences on 2025-09

Healthcare • Consulting • Biotechnology

Character Biosciences is a precision medicine biotechnology company focused on understanding and treating progressive polygenic eye diseases, with an initial emphasis on age-related macular degeneration (AMD) and primary open-angle glaucoma (POAG). The company integrates large human genomic datasets with longitudinal clinical data, retinal imaging, and AI-enabled biomarker quantification to identify genetic drivers of disease progression and to guide targeted drug discovery and development. Character Biosciences partners with healthcare providers, patients, and industry collaborators to translate genomic and machine-learning insights into more effective, subtype-targeted ophthalmology therapies.

📋 Description

• Own operational delivery of one or more Dry AMD clinical trials from startup through close-out • Drive study timelines, quality, and issue resolution • Oversee study-level operational plans and risk mitigation strategies • Provide input and support for NDAs, MAAs, inspection readiness activities, and regulatory inspections • Serve as a subject matter expert during regulatory inspections • Identify and select vendors, critically review contracts and work orders, and manage vendor performance and relationships • Oversee CRO monitoring activities to ensure site performance, enrollment, and data quality meet study goals • Support development and tracking of study and program budgets • Flag budget variances and ensure fiscal discipline • Build and refine SOPs, systems, and workflows for scalable clinical operations • Ensure trials comply with GCP and applicable regulatory standards • Maintain inspection-ready trial master files and clinical systems • Partner with internal cross-functional teams to align operational plans with program strategy • Provide timely updates on study status, risks, and timelines to program and senior leadership • Help shape Development Operations processes and structure • Build and lead a team as the function grows

🎯 Requirements

• Bachelor’s degree required; Master’s degree preferred • 5–7+ years of Clinical Operations experience across multiple trial phases • 2+ years of ophthalmology experience; retina experience a plus • Extensive experience managing CROs, vendors, and sites • Strong understanding of GCP, ICH guidelines, and clinical trial regulations • Proven ability to shape operational strategy and drive execution across more than one study or program at a time • Strong budget and vendor management skills • Experience tracking spend and flagging variances • Excellent cross-functional collaboration skills • Ability to partner effectively with internal and external stakeholders • Comfortable operating independently in a lean, fast-moving biotech environment • High integrity and strong judgment • Track record of delivering complex clinical trials on time and within budget • Applicants must be authorized to work in the United States

🏖️ Benefits

• Equity • Medical insurance • Dental insurance • Vision insurance • 401(k) • Accrued paid time off policy • Competitive salary • Strong equity incentives • Diversity, equity, and inclusion commitment