About AbbVie
At AbbVie, we are driven by a mission to discover and deliver innovative medicines and solutions that address today’s serious health challenges and prepare for tomorrow’s. Our focus spans several therapeutic areas, including immunology, oncology, neuroscience, and eye care, alongside our Allergan Aesthetics portfolio. Every day, we strive to make a meaningful difference in patients’ lives by combining advanced science with operational excellence.
Position Overview
We are seeking a Clinical Operations Program Director (Program Lead II – Clinical Program Development) to connect science and operations, bringing clinical studies from concept to reality. In this pivotal leadership role, you will provide strategic direction for one or more clinical research programs, integrating scientific vision with operational execution.
You will serve as a strategic partner to cross-functional leaders, guiding the development and delivery of clinical programs while mentoring a team of clinical operations professionals. This position offers the opportunity to directly influence AbbVie’s pipeline, ensure data-driven decision-making, and make a lasting impact on patients worldwide.
Key Responsibilities
Strategic Leadership
- Serve as a core member of the Integrated Evidence Strategy Team within the Pipeline Commercialization Model, aligning clinical operations with the asset strategy.
- Collaborate with the Asset Strategy Team and Development Review Committee to maximize portfolio value.
- Design and implement the clinical operational strategy, balancing trial complexity, speed, and patient availability.
- Evaluate program risks, develop mitigation plans, and present strategic options in high-stakes decision environments.
Program & Portfolio Management
- Oversee clinical program execution, from study timelines to patient enrollment strategies.
- Contribute to portfolio planning, including budgeting, resource allocation, and timeline forecasting.
- Review and contribute to clinical and regulatory documents (e.g., INDs, IBs, NDAs, BLAs, MAAs, briefing books).
- Manage multi-million-dollar external program budgets ($20M–$200M+).
Cross-Functional Collaboration
- Influence and partner with stakeholders across Development Operations, Clinical Development, Medical Affairs, and Regulatory Affairs.
- Lead large-scale innovation and process improvement initiatives with measurable business impact.
People Development
- Directly manage 4–15 study managers and indirectly guide up to 30 additional team members.
- Foster an inclusive, innovative, and learning-oriented culture.
- Mentor and prepare high-potential staff for leadership roles.
Compliance & Quality
- Ensure all programs meet ICH/GCP, global regulations, and AbbVie policies.
- Champion ethical, compliant, and patient-focused research practices.
Qualifications
Required:
- Bachelor’s degree in nursing or a scientific field (Associate’s degree/R.N. with significant experience considered).
- 12+ years of pharma or clinical research experience.
- 10+ years leading global clinical research teams.
- Proven expertise in risk management, strategic decision-making, and operational leadership.
- Strong communication skills with demonstrated ability to influence at all levels.
- Experience managing complex budgets and timelines.
Preferred:
- Remote team leadership experience.
- Familiarity with ICH guidelines, global regulations, and compliance frameworks.
- Successful track record in initiating and completing studies across multiple phases (I–IV).
Compensation & Benefits
- Base Pay Range: Competitive, based on location and experience (subject to state/local pay disclosure laws).
- Bonus & Incentives: Eligible for short-term and long-term incentive programs.
- Benefits:
- Paid vacation, holidays, and sick leave
- Comprehensive medical, dental, and vision insurance
- 401(k) retirement plan
- Professional development opportunities
Why Join AbbVie?
At AbbVie, you’ll work alongside some of the brightest minds in the industry on projects that truly matter. You’ll have the chance to influence groundbreaking research, shape the future of patient care, and grow your career in a collaborative, forward-thinking environment.
