Senior Clinical Operations Program Lead

BioSpace; Branchburg Township (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking a Clinical Operations Program Director to connect science and operations, leading clinical studies across programs with a global mindset. You will advocate for pipeline assets and drive operational strategy, budgets, timelines, and risk mitigations while mentoring a team within Development Operations.

Responsibilities include cross-functional leadership, regulatory content support, and ensuring compliance with ICH/GCP and global regulations, while fostering an inclusive,

Qualifications

• Bachelor’s degree or equivalent; nursing or scientific field.
• 12+ years pharma/clinical research experience.
• 10 years leading global clinical studies and teams.
• Experience in risk management and strategic execution.
• Strong communication and coaching skills.
• Remote management experience preferred.
• Subject matter expert in ICH, global regulations, ethics.

Responsibilities

• Develop the clinical operational strategy and oversee execution of studies/programs.
• Lead cross-functional teams to align science and operations.
• Assess risks and provide mitigations to asset strategy.
• Interact with management and cross-functional colleagues to drive objectives.
• Lead portfolio planning with costs, resources, and timelines.
• Contribute to regulatory documents (INDs, IB, NDAs, etc.).
• Manage external budgets across portfolios (up to $200M).
• Drive cross-functional process improvements and change management.
• Mentor and develop clinical operations staff; support career growth.

Skills

Leadership

Risk management

Strategic execution

Communication skills

Coaching/mentoring

Remote management experience

Regulatory knowledge

Education

Bachelor’s degree or equivalent

Associate’s degree / RN acceptable

Job description

AbbVie is seeking a Clinical Operations Program Director to connect science and operations, leading clinical studies across programs with a global mindset. You will advocate for pipeline assets and drive operational strategy, budgets, timelines, and risk mitigations while mentoring a team within Development Operations.

Responsibilities include cross-functional leadership, regulatory content support, and ensuring compliance with ICH/GCP and global regulations, while fostering an inclusive,