Program Lead II
AbbVie
Summary
The Clinical Operations Program Director connects 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 and provides operational reality to scientific experiments via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. Also serves as an inspiring people leader responsible for developing a pipeline of talent for the Development Operations organization.
Job description
Responsibilities
- Integral member of the Pipeline Commercialization Model's Integrated Evidence Strategy Team and strategic partner for the Asset Strategy Team and Development Review Committee.
- Develops the clinical operational strategy and is responsible for the execution of clinical studies/programs (operational timelines, enrollment options, patient population availability, balancing trial design complexity vs speed).
- Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy.
- Identifies strategic options for the Asset Strategy Team 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.
- Key contributor to the portfolio planning process including development of costs, resource projections and timelines for clinical development programs.
- Reviews and provides clinical operations content to clinical and regulatory documents (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.
- Responsible for developing, managing, mentoring clinical operations staff, including direct supervision of 4-15 study managers and up to 30 indirect staff.
- Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
Qualifications
- Bachelor's degree or equivalent required, typically in nursing or scientific field; Associate's degree/R.N. or equivalent with relevant experience acceptable.
- Must have 12+ years of Pharma-related/clinical research related experience.
- 10 years in clinical research demonstrating high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team.
- Experience in risk management, decision-making, and strategic execution is critical.
- Good communication skills.
- Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).
- Subject matter expert in standard business procedures (ICH, Global Regulations, Ethics and Compliance).
- Experience in successful study initiation through study completion, primary data analysis, and/or multiple phases of studies (Phase 1-3, 4).
Requirements
- 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 related experience
- 10 years in clinical research demonstrating core, technical, and leadership competencies
- Experience in risk management, decision-making, and strategic execution
- Good communication skills
- Coaching, mentoring, and people management experience
- Subject matter expert in ICH, Global Regulations, Ethics and Compliance
- Experience in study initiation through study completion, primary data analysis, and/or multiple phases of studies (Phase 1-3, 4)
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.