Senior Clinical Operations Program Lead

BioSpace; Branchburg Township (NJ); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Clinical Operations Program Director to connect science and operations, guiding clinical studies from inception to completion. You will lead a global team, drive strategic execution, manage budgets and timelines, and ensure regulatory and quality compliance across assets and programs.

You will mentor staff, collaborate with cross-functional partners, and advocate for pipeline assets while delivering innovative solutions to complex trials in a fast-paced environment.

Qualifications

• Bachelor's degree or equivalent required in nursing or scientific field; Associates degree/R.N. acceptable with relevant experience.
• 12+ years of Pharma-related/clinical research experience or applicable work experience.
• 10 years in clinical research with leadership of global teams and multiple studies.
• Experience in risk management, strategic execution and decision-making.
• Strong communication and coaching/mentoring skills; remote management preferred.
• Subject matter expert in ICH, Global Regulations, Ethics and Compliance.
• Experience in study initiation through completion (Phase I–III, IV).

Responsibilities

• Develop clinical operational strategy aligned with asset strategy and oversee execution of clinical studies/programs.
• Lead cross-functional teams across Development Operations and Regulatory to maximize asset value.
• Evaluate risks and mitigations; identify strategic options for asset strategy team.
• Manage budgets, costs, resources, and timelines for development programs.
• Contribute to study documentation, INDs, IBs, NDAs, BLAs, MAAs and regulatory briefing books.
• Mentor and develop clinical operations staff, including remote management.
• Ensure compliance with quality standards (ICH/GCP, Global Regulations).

Skills

Strategic leadership

Global mindset

Risk management

Program execution

Executive communication

Coaching/mentoring

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree or equivalent in nursing or scientific field

Associates degree/R.N. acceptable with relevant experience

Job description

AbbVie is seeking a Clinical Operations Program Director to connect science and operations, guiding clinical studies from inception to completion. You will lead a global team, drive strategic execution, manage budgets and timelines, and ensure regulatory and quality compliance across assets and programs.

You will mentor staff, collaborate with cross-functional partners, and advocate for pipeline assets while delivering innovative solutions to complex trials in a fast-paced environment.