Associate Director, Clinical Operations

Job description

Role : Associate Director, Clinical Operations Reports to: Aggie Malloy Department: Clinical Research Team: Clinical Operations Level: 8 Location : Remote 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 reporting to Aggie Malloy. Responsibilities 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 About You 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 Compensation & Benefits The annual pay range for this full-time position is $179,000-$210,000 + equity + benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skill set, years and depth of experience, certifications and work location. Benefits include a competitive salary, strong equity incentives, medical, dental, vision, 401(k), and an accrued paid time off policy. Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture. EEO Statement 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. Work Authorization Applicants must be authorized to work in the United States. About Character Biosciences Character Biosciences is a precision medicine company pioneering targeted therapies for ophthalmology. Our patient data platform integrates genomics with deep, longitudinal clinical and imaging data, enabling us to uncover genetic drivers of disease progression, advance novel therapeutics, and define patient stratification strategies that improve clinical success. Our interdisciplinary team spans human genetics, clinical science, data science and engineering, and drug discovery and development. We are advancing two programs for Dry Age-related Macular Degeneration (AMD) into the clinic, with additional discovery-stage programs underway. Founded in 2018, Character has raised capital from leading investors at the intersection of healthcare and technology, including an oversubscribed $110+ million Series B in 2025 co-led by aMoon and Luma Group, with participation from Bausch + Lomb, Innovation Endeavors, Sanofi Ventures, Catalio Capital Management, S32, KdT Ventures, and Jefferson Life Sciences. We also maintain a multi-target drug discovery collaboration with Bausch + Lomb to develop innovative precision medicines for AMD.