Associate Director, Clinical Operations

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 reporting to Aggie Malloy.

Clinical Trial Operations & Delivery

• →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

Process, Compliance & Cross-Functional Leadership

• →Operational Excellence: Build and refine SOPs, systems, and workflows that make clinical operations scalable as Character’s pipeline grows
• →GCP Compliance: Ensure trials are conducted to GCP and applicable regulatory standards; maintain inspection-ready trial master files and clinical systems
• →Cross-Functional Partnership: Partner closely with the internal cross-functional team to keep operational plans aligned with program strategy
• →Executive Reporting: Provide clear, timely updates on study status, risks, and timelines to program and senior leadership
• →Team Building: Help shape Development Operations processes and structure at Character, with the opportunity to build and lead a team as the function grows

You bring deep, hands-on clinical operations experience and are energized by the chance to help build the operational foundation for a growing ophthalmology-focused biotech. You move fluidly between the details of day-to-day trial execution and the bigger picture of how our operational processes need to evolve as Character’s pipeline advances. You’re comfortable owning a portfolio of studies independently, anticipating risks before they become issues, and driving vendors and cross-functional partners toward shared timelines.

You are collaborative, detail-oriented, and thrive in a fast-moving, resource-lean environment where processes are still being built. You bring credibility and sound judgment to partner effectively with cross functional colleagues. Like us, you value integrity, individual accountability, team camaraderie, open communication, and a commitment to continuous learning and operational excellence.

• Bachelor’s degree required; Master’s degree preferred
• 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

Character Biosciences is an equal opportunity employer and is committed to building a diverse and inclusive workforce. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.

Applicants must be authorized to work in the United States.