Note: The job is a remote job and is open to candidates in USA. Character Biosciences is a precision medicine company pioneering targeted therapies for ophthalmology. The Associate Director, Development Operations will lead the operational delivery of clinical trials for the company’s Age-related Macular Degeneration pipeline, overseeing study execution, vendors, sites, budgets, compliance, and cross-functional coordination. The role will also help build scalable Development Operations processes and potentially lead a team as the function grows.
Responsibilities
- Own operational delivery of one or more Dry AMD clinical trials, driving timelines, quality, and issue resolution from startup through close-out
- Oversee development of study-level operational plans and risk mitigation strategies in partnership with relevant functions
- Provides input and support for regulatory activities including NDAs, MAAs, inspection readiness activities and serves as a subject matter expert during regulatory inspections
- Oversees and responsible for vendor identification and selection including critical review of contracts, and/or work orders and management of ongoing performance as well as vendor 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, flagging variances and ensuring fiscal discipline
- Build and refine SOPs, systems, and workflows that make clinical operations scalable as Character’s pipeline grows
- Ensure trials are conducted to GCP and applicable regulatory standards; maintain inspection-ready trial master files and clinical systems
- Partner closely with the internal cross-functional team to keep operational plans aligned with program strategy
- Provide clear, timely updates on study status, risks, and timelines to program and senior leadership
- Help shape Development Operations processes and structure at Character, with the opportunity to build and lead a team as the function grows
Skills
- * Bachelor's degree required
- 5–7+ years of Clinical Operations experience across multiple trial phases, including 2+ years of ophthalmology experience (retina experience a plus)
- * Extensive experience managing CROs, vendors, and sites, with a 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, with experience tracking spend and flagging variances
- * Excellent cross-functional collaboration skills; able to partner effectively with internal and external stakeholders
- * Comfortable operating with a high degree of independence in a lean, fast-moving biotech environment
- * High integrity, strong judgment, and a track record of delivering complex clinical trials on time and within budget
- Applicants must be authorized to work in the United States
- Master's degree preferred
Benefits
- Equity
- Strong equity incentives
- Medical
- Dental
- Vision
- 401(k)
- An accrued paid time off policy
Company Overview