Program Lead II

Summary

Join AbbVie as a Clinical Operations Program Director and lead the execution of clinical research programs, connecting science and operations. Develop and implement clinical operational strategies, ensuring projects are completed on time and within budget. Translate asset strategies into operational plans, identifying and mitigating risks. Collaborate with cross-functional teams and senior leaders. Manage external budgets and mentor team members, fostering an inclusive and innovative work environment. Ensure compliance with quality standards and effectively communicate with stakeholders. This role requires significant experience in clinical research and leadership.

Requirements

• Bachelor’s degree or equivalent is required, typically in nursing or scientific field. An Associate’s 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)
• Must have 8 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy
• Proven ability in leading a global team in the management and completion of multiple, complex clinical studies
• Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred)
• Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Integral participation in initiatives or advancement strategies for clinical operations
• Experience in successful study initiation through study completion/primary data analysis and in multiple phases of studies (Phase 1-3, 4)
• Must possess good communication skills

Responsibilities

• Develop clinical operational strategy and ensure clinical research programs are executed with quality and efficiency, on-time, within budget, and to meet company objectives
• Translate asset strategy into operational execution by developing the clinical operations plan (or strategy) and connecting the science with the business, operations, patients and our customers
• Identify and evaluate risks and mitigations at program level to achieving the asset strategy
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives and represents Clinical Development Operations at senior leader cross functional meetings
• Reviews and provides clinical operations content to clinical and regulatory documents
• Manage overall external budget management across their portfolio (programs can be 20-200 million dollars)
• Responsible for bringing the best out of our talent, mentoring and supporting development to enable growth including direct management of study manager(s)
• Create an inclusive, innovative and learning environment where staff and studies/programs will succeed
• Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
• Strong communication and stakeholder management skills. Is comfortable with not having all the information yet able to drive activities and find solutions to deliver on the program

Preferred Qualifications

There is potential for the role to be remotely with regular scheduled travel to AbbVie office

Benefits

• Medical/dental/vision insurance
• 401(k)
• Paid time off (vacation, holidays, sick)
• Short-term incentive programs
• Long-term incentive programs