Program Lead II
AbbVie
Full-time
Remote friendly (Bangor, ME)
United States
$156,000 - $296,500 USD yearly
Clinical Research and Development
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Role Summary
Program Lead II responsible for connecting science and operations to bring clinical studies to life through the execution of one or more clinical research programs. Serves as a strategic advocate for pipeline assets, provides operational insight to scientific work, and leads a talent pipeline within Development Operations.
Responsibilities
- Develop and execute clinical operational strategy aligned with asset strategy; create operational timelines, enrollment options, and assess patient population availability while balancing trial design complexity and speed.
- Evaluate programmatic risks and mitigations to achieve asset strategy; identify strategic options for the Asset Strategy Team amid competing priorities and challenges.
- Influence management and cross-functional teams to achieve program objectives within Development Operations and related functions.
- Contribute to portfolio planning including costs, resource projections, and timelines for clinical development programs.
- Review and provide clinical operations content for clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books).
- Manage external budget across portfolio (programs can range from 20–200 million dollars).
- Lead cross-functional innovation and process improvement initiatives with significant business impacts and manage change across supporting areas.
- Develop, manage, and mentor clinical operations staff (direct and indirect), overseeing 4–15 study managers and up to 30 indirect staff; foster career development and an inclusive, innovative environment.
- Ensure execution of clinical programs in compliance with ICH/GCP, global regulations, and AbbVie policies.
Qualifications
- Bachelor’s degree or equivalent (typically in nursing or scientific field); Associate’s degree/R.N. or equivalent with relevant experience acceptable.
- 12+ years of pharma-related/clinical research experience (or applicable work experience).
- 10 years (and/or applicable experience) in clinical research with leadership of global teams and multiple studies; demonstrated ability to set strategy and manage programs.
- Experience in risk management, decision-making, and strategic execution; ability to base pipeline decisions on sound data.
- Strong communication skills; proven coaching, mentoring, and people management (remote management experience preferred).
- Subject matter expert in standard business procedures (ICH, Global Regulations, Ethics and Compliance).
- Active participation in initiatives or strategies to advance clinical operations; experience across study initiation to completion and data analysis in multiple phases (Phase I–III, 4).
Skills
- Strategic planning and program management
- Cross-functional leadership and collaboration
- Risk assessment and mitigation
- Budget management and resource forecasting
- Regulatory documentation and compliance
- Mentoring and developing talent
- Effective communication across diverse stakeholders
Education
- Bachelor’s degree or equivalent (nursing or scientific field); Associate’s degree/R.N. or equivalent with relevant experience acceptable.
Additional Requirements
- Experience with large-scale budgets and global study execution
- Ability to manage and lead large, distributed teams and complex programs