Strategic Clinical Operations Director

AbbVie Inc.; Irvine (CA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Long-Term incentives

Job summary

AbbVie Inc. in Irvine, CA is seeking a Clinical Operations Program Director to connect science and operations, leading one or more clinical research programs.

You will serve as strategic advocate for pipeline assets and translate scientific experiments into executable study plans. The role includes developing operational strategies, managing budgets, leading 4–15 study managers, mentoring staff, and ensuring compliance with ICH/GCP and global regulations.

Qualifications

• Bachelor’s degree or equivalent in nursing or scientific field (RN acceptable).
• 12+ years pharma-related/clinical research experience.
• 10 years leading global clinical studies and driving strategy.
• Experience in risk management and strategic execution is critical.
• Strong communication and people-management skills (remote experience preferred).
• ICH/Global Regulations/Compliance knowledge and SME in clinical ops.

Responsibilities

• Develop and execute the clinical operational strategy for one or more programs.
• Create timelines, enrollment options and assess patient populations.
• Identify risk and mitigation options to support asset strategy.
• Influence cross-functional teams to meet program objectives.
• Contribute to portfolio planning: costs, resources, timelines.
• Provide content for regulatory documents (INDs, IB, NDAs, BLAs, MAA).
• Oversee external budget across portfolios (20–200M).
• Lead cross-functional innovation and process improvements.
• Develop and mentor clinical operations staff (4–15 direct, up to 30 indirect).
• Ensure compliance with ICH/GCP and global regulations.

Skills

Leadership

Risk management

Strategic thinking

Communication skills

Mentoring

Education

Bachelor’s degree or equivalent in nursing or scientific field

Job description

AbbVie Inc. in Irvine, CA is seeking a Clinical Operations Program Director to connect science and operations, leading one or more clinical research programs.

You will serve as strategic advocate for pipeline assets and translate scientific experiments into executable study plans. The role includes developing operational strategies, managing budgets, leading 4–15 study managers, mentoring staff, and ensuring compliance with ICH/GCP and global regulations.