Associate Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate clinical operational strategy and supervise global clinical study teams, CROs, and vendors.

• Ensure that studies are executed on schedule, within budget, and in accordance with RayzeBio SOPs and ICH/GCP guidelines.

• Manage the execution of clinical trials, which includes planning and feasibility, start-up, conduct, close-out, and reporting.

• Identify and assess operational risks along with their mitigations at the program level.

• Contribute to the development of clinical plans and the design of clinical protocols.

• Lead cross-functional study execution teams to achieve study objectives and deliverables.

• Proactively escalate issues to key internal stakeholders to ensure timely resolution.

• Conduct oversight reviews and quality control of CRO and vendor activities.

• Ensure adherence to key performance metrics and maintain inspection readiness.

• Support governance meetings with CROs and vendors, contributing to governance structures, plans, performance data, and risk escalations.

• Drive ongoing process improvements and the adoption of best practices.

• Ensure global inspection readiness and lead interactions during regulatory inspections.

• Utilize AI tools to boost individual productivity and enhance work quality.

• Perform other related duties as assigned.

⛳️ Requirements

• BA/BS degree preferred in a scientific or healthcare discipline.

• A minimum of 6–8 years of relevant clinical operations experience in the pharmaceutical or biotech industry.

• At least 3 years of experience in oncology trials.

• Previous people management or leadership experience is preferred.

• Experience with radiopharmaceuticals, theranostics, and/or companion diagnostics is highly desirable.

• Strong leadership and project management skills across complex programs and cross-functional teams.

• Strong financial and resource management capabilities.

• Extensive knowledge of global clinical trial operations and regulations, including ICH-GCP.

• Detail-oriented, action-focused, organized, and dedicated to quality and consistency.

• Ability to navigate a dynamic environment with a high degree of flexibility.

• Proficiency in Microsoft Project and SmartSheets is desired.

• Willingness to travel up to 20%.

🏝️ Benefits

• Additional discretionary incentive cash and stock opportunities.

• Wellbeing support.

• Retirement and financial protection benefits.

• Medical, dental, vision, life, and disability insurance offerings.

• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for eligible new hires.

• 3 optional holidays for eligible employees.

• Paid sick leave, depending on eligibility.

• Up to two paid volunteer days per year.

• Summer hours flexibility.

• Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.

• Annual Global Shutdown between Christmas Day and New Year's Day.

• Reasonable workplace accommodations/adjustments and ongoing support.