Program Lead II, Clinical Program Development

About the role

AbbVie is looking for a Program Lead II in Clinical Program Development. The role connects science and operations to bring clinical studies to life, acting as a strategic advocate for pipeline assets and providing operational reality to scientific experiments. It also involves developing a pipeline of talent for the Development Operations organization.

Key responsibilities

• Develop clinical operational strategy so that clinical research programs run with quality and efficiency, on time and within budget.
• Translate asset strategy into operational execution by building the clinical operations plan and linking science with business, operations, patients and customers.
• Identify and evaluate risks and mitigations at program level.
• Influence management and cross-functional teams and represent Clinical Development Operations at senior-level meetings.
• Review and provide clinical operations content to clinical and regulatory documents.
• Manage the overall external budget across the portfolio (programs of 20-200 million dollars).
• Mentor and support development, including direct management of study managers, and create an inclusive, learning environment.
• Run clinical programs in line with quality standards (ICH/GCP, global regulations and AbbVie policies).

Required profile

• Bachelor's degree or equivalent, typically in nursing or a scientific field; an Associate's degree, R.N. or equivalent with relevant experience is acceptable.
• 12+ years of pharma-related or clinical research experience.
• 8 years in clinical research showing strong technical and leadership competencies.
• Proven ability to lead a global team through multiple complex clinical studies.
• Successful coaching, mentoring and people management (remote management experience preferred).
• Experience taking studies from initiation through completion and primary data analysis, across Phase 1-4.

Required skills

• Subject matter expertise and competence in SOPs, ICH, global regulations, ethics and compliance.
• Good communication and stakeholder management skills.
• Able to drive activities and find solutions even when information is incomplete.