Associate Director, Development Operations

Character Biosciences

13d•$179,000 - $210,000•Remote

About The Position

We’re looking for an experienced, execution-focused Associate Director, Development 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.

Requirements

Bachelor’s degree required
5–7+ years of Clinical Operations experience across multiple trial phases
2+ years of ophthalmology experience
Extensive experience managing CROs, vendors, and sites
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.

Nice To Haves

Master’s degree preferred
retina experience a plus

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