Associate Director, Development Operations
New
C
Character BiosciencesBiotechnology
United StatesFull-TimeManager
Salary$179,000-$210,000 / year + equity + benefits
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Job Details
- Experience
- 5–7+ years of Clinical Operations experience across multiple trial phases, including 2+ years of ophthalmology experience
- Required Skills
- GCPBudget management
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 and ICH guidelines.
- Demonstrated knowledge of clinical trial regulations.
- Proven ability to shape operational strategy and drive execution for multiple studies.
- Strong budget and vendor management skills with variance tracking experience.
- Excellent cross-functional collaboration skills.
- Ability to work independently in a fast-moving biotech environment.
Responsibilities
- Own operational delivery of one or more Dry AMD clinical trials, driving timelines, quality, and issue resolution.
- Oversee development of study-level operational plans and risk mitigation strategies.
- Provide input for regulatory activities including NDAs and inspection readiness.
- Manage vendor/CRO identification, selection, and performance monitoring.
- Ensure site performance, enrollment, and data quality meet study goals.
- Support development and tracking of study budgets and ensure fiscal discipline.
- Build and refine SOPs and systems for scalable clinical operations.
- Maintain inspection-ready trial master files and clinical systems.
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