Program Lead II, Clinical Program Development

• 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

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 a inspiring people leader responsible for developing a pipeline of talent for the Development Operations organization.

• 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.
• Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.