About Character Biosciences Character Biosciences is a precision medicine company pioneering targeted therapies for ophthalmology. Backed by Innovation Endeavors.
About the role
We’re looking for an experienced, execution-focused Associate Director, Clinical Operations to lead the operational backbone of Character’s clinical programs as we advance our Age-related Macular Degeneration (AMD) pipeline through the clinic. You’ll take ownership of a portfolio of studies — driving day-to-day execution, vendor and site performance, and cross-functional coordination with Medical, Data, and Regulatory to keep our trials on time, on budget, and in compliance with GCP.
What they're looking for
- Study Execution: Own operational delivery of one or more Dry AMD clinical trials, driving timelines, quality, and issue resolution from startup through close-out
- Operational Strategy: Oversee development of study-level operational plans and risk mitigation strategies in partnership with relevant functions
- Regulatory Activities: Provides input and support for regulatory activities including NDAs, MAAs, inspection readiness activities and serves as a subject matter expert during regulatory inspections
- Vendor & CRO Management: 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
- Monitoring/Site Oversight: Oversee CRO monitoring activities to ensure site performance, enrollment, and data quality meet study goals
- Budget Oversight: Support development and tracking of study and program budgets, flagging variances and ensuring fiscal discipline
More about this role
Role : Associate Director, Clinical Operations
Team: Clinical Operations
Level: 8
The Opportunity
We’re looking for an experienced, execution-focused Associate Director, Clinical Operations to lead the operational backbone of Character’s clinical programs as we advance our Age-related Macular Degeneration (AMD) pipeline through the clinic. You’ll take ownership of a portfolio of studies — driving day-to-day execution, vendor and site performance, and cross-functional coordination with Medical, Data, and Regulatory to keep our trials on time, on budget, and in compliance with GCP. This role sits at the center of Character’s mission: the operational rigor you bring directly determines how quickly we can generate the clinical evidence needed to bring novel therapies to patients with retinal disease.
You’ll shape how we run trials as much as you’ll run them, refining processes and systems so they scale cleanly as our pipeline and team grow, while staying close enough to the work to solve problems in real time. As Character’s clinical portfolio and Development Operations function scale, there is real opportunity to build and lead a team over time.
This is an in-office or remote role...
Browse similar: Startup jobs · Remote jobs