Senior Clinical Operations Program Lead

AbbVie Inc.

Florham Park (NJ)

On-site

USD 180,000 - 240,000

Full time

2 days ago
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Benefits offered by this job

Paid time off
Medical/dental/vision insurance
401(k)
Long-term incentive programs

Job summary

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

The role requires serving as a strategic advocate for pipeline assets, translating science into operational plans, and leading a team across the Development Operations function. You will drive operational strategy, manage budgets, and ensure compliance with ICH/GCP and regulatory standards while developing future clinical operations leaders within a

Qualifications

  • 12+ years of pharma/clinical research experience.
  • 10+ years leading global clinical study strategy and teams.
  • Experience in risk management and strategic execution.
  • Strong communication and mentoring skills.
  • Subject matter expert in ICH, global regulations, ethics and compliance.
  • Experience across Phases I–III and 4.

Responsibilities

  • Develop clinical operational strategy and execute studies/programs with timelines and enrollment options.
  • Evaluate risks and mitigations to asset strategy; propose strategic options.
  • Influence cross-functional teams to achieve program objectives within Development Operations.
  • Contribute to portfolio planning with costs, resources, and timelines for development programs.
  • Provide content to regulatory documents (INDs, IB, NDAs, BLAs, MAAs).
  • Manage external budget across portfolio (up to $20–$200M).
  • Lead large cross-functional innovation and process improvement initiatives with significant business impact.
  • Develop and mentor clinical operations staff (4–15 study managers; up to 30 indirect).
  • Ensure program execution in compliance with ICH/GCP and regulations.

Skills

Strategic leadership
Cross-functional collaboration
Mentoring & people management
Communication

Education

Bachelor’s degree or equivalent
Associate’s degree / RN or equivalent

Job description

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

The role requires serving as a strategic advocate for pipeline assets, translating science into operational plans, and leading a team across the Development Operations function. You will drive operational strategy, manage budgets, and ensure compliance with ICH/GCP and regulatory standards while developing future clinical operations leaders within a

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