Associate Director Clinical Operations

Character Biosciences is a drug discovery and development company building world-class, deeply-phenotyped databases that integrate genomics with longitudinal clinical and imaging data. Our interdisciplinary team, comprising experts in clinical science, data science, statistical genetics, machine learning and drug discovery utilize this platform to determine genetic drivers of disease progression, advance novel therapeutics and define genetics-based patient stratification. Powered by our data platform, Character Bio is currently advancing two programs in Dry Age-related Macular Degeneration with additional programs in earlier stages of discovery research.

Character is seeking an exceptional Associate Director of Clinical Operations to ensure the appropriate planning and execution of early-stage, proof-of-concept, and registrational trials. Reporting to the Chief Scientific Officer, this role will be responsible for managing one or more trials and will be responsible for the effective management and oversight of clinical trial budgets, timelines, and resources to meet the defined deliverables. The ideal candidate will demonstrate a blend of operational excellence, clinical expertise, and leadership acumen to ensure successful execution of assigned trials.

Responsibilities:

• Plan and manage the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Develop and manage clinical trial timelines and operational plans, ensuring effective cross-functional communication and timely updates to stakeholders
• Lead the design and development of core study documents, study plans, and systems setup to ensure operational excellence.
• Oversee vendor selection, contract negotiation, and performance, ensuring deliverables meet quality, timeline, and budget expectations.
• Collaborate with the observational study team to identify and select high-quality sites for clinical trials, ensuring alignment with study protocol and site capabilities.
• Provide oversight and guidance to clinical study team members or contracted vendors in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high-impact quality-related topics for assigned studies.
• Ensure set-up and implementation of effective investigator and site monitor training.
• Facilitate site engagement and communications with investigators and/or staff to support study milestones and deliverables.
• Participate in and/or facilitate cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress, and timely completion of 
• Manage clinical inspection readiness activities and ensure compliance with quality standards.
• Mentor and develop team members, fostering a learning culture and supporting professional growth within the organization.
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables.

Key qualifications:

• BA/BS degree with 5 years of relevant experience working in the pharmaceutical/biotech industry managing clinical trials
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Requires strong clinical research operational knowledge, project planning, communication, and presentation skills. 
• Strong expertise in vendor management
• Deep understanding of protocol and clinical drug development processes, clinical trial design, and trial planning and management.
• Exceptional interpersonal, written, and verbal communication skills, with the ability to build relationships and drive collaboration across diverse stakeholders.
• Strong problem-solving and organizational skills, with a focus on achieving results in a dynamic startup environment.
• Ability to balance technical expertise with strategic thinking and decision-making.

Benefits include a competitive salary, strong equity incentives, medical, dental, vision, 401(k), and a flexible 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. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. We are an E-Verify company.