Program Lead II

Role Summary

The Clinical Operations Program Director is responsible to connect science and operations to bring clinical studies to life through the execution of one or more clinical research programs. The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational reality to our scientific experiments via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as an inspiring people leader responsible for developing a pipeline of talent for the Development Operations organization.

Responsibilities

• Integral member of the Pipeline Commercialization Model‚Äôs Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee whose remit is to maximize the value of our assets and portfolio for patients and AbbVie.
• In alignment with the asset‚Äôs strategy and incorporating the science and the operations, develops the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed).
• Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy.
• Identifies strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests or unanticipated challenges.
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives: primary scope of influence is within Development Operations, cross- functional colleagues who support clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs.
• Key contributor to the portfolio planning process including responsibility for the development of the costs, resource projections and timelines for the clinical development programs under consideration.
• Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books).
• Responsible for overall external budget management across their portfolio (programs can be 20-200 million dollars).
• Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts and ensures effective change management across the cross-functional areas that support clinical program execution.
• Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 ‚Äì 15 study manager(s) and up to 30 indirect staff, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed.
• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).

Qualifications

• Bachelor‚Äôs degree or equivalent is required, typically in nursing or scientific field. An Associate‚Äôs degree/R.N. or equivalent with relevant experience is acceptable.
• Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience).
• 10 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
• Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.
• Possesses good communication skills.
• Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).
• Considered a subject matter expert in the application of standard business procedures (ICH, Global Regulations, Ethics and Compliance).
• Integral participation in initiatives or advancement of strategies for clinical operations.
• Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase l-3, 4).

Skills

• Strategic thinking and leadership
• Risk assessment and mitigation
• Budget management and financial planning
• Cross-functional collaboration
• Regulatory documentation and quality standards

Education

• Bachelor‚Äôs degree or equivalent required; nursing or scientific field preferred
• Additional advanced degree or certifications not specified