The Director, Clinical Operations provides strategic and operational leadership for clinical trials and programs and is accountable for their on-time and on-budget delivery. The role will oversees Clinical Trial Managers and study teams, ensures high-quality execution across multiple trials, and contributes to program-level strategy according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional regulations.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Develop clinical operational strategy and oversee global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and in adherence with ICH/GCP guidelines
- Oversee all operational aspects of clinical trial execution including planning and feasibility, start-up, conduct, close-out, and reporting
- Identify and evaluate operational risks and mitigations at a program level
- Contribute to clinical development plans and clinical protocol design
- Leads the cross-functional study execution team in achieving the study goals and deliverables
- Proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
- Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness
- Support CRO and vendor governance meetings and contributes to governance structure and plans, performance data and escalations study/program risks, as needed
- Drive continuous process improvement and implementation of best practices
- Ensure global inspection readiness and lead interactions during regulatory inspections
- Performs other related duties as assigned
- Leverage AI tools to enhance individual productivity and quality of work
- Up to 20% travel required
Education and Experience- BA/BS degree, scientific or healthcare discipline preferred
- Minimum 6-8 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 3 years in oncology trials
- Prior people management or leadership experience preferred
- Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable
Skills and Qualifications - Independent professional who proactively communicates frequently and effectively.
- Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making
- Strong financial and resource management skills
- Deep knowledge of global clinical trial operations and regulations (ICH-GCP)
- Detail and action-oriented, organized and committed to quality and consistency.
- Ability to work in a dynamic environment with a high degree of flexibility.
- Expertise in Microsoft Project and SmartSheets desired.
Work Environment The noise level in the work environment is usually moderate.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Remote - United States - US: $173,217 - $209,899
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
R1606173 : Associate Director, Clinical Operations
