Program Lead I/II
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This role can be hired at a Program Lead I or a Program Lead II level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities
Location: This role may be full-time AbbVie HQ (North Chicago) or AbbVie Affiliate office-based or full-time remote/home-based depending on business need.
- Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Interacts with and influences all levels of management and cross-functional team members to develop clinical strategies and execute action plans to achieve program objectives.
- Represent Clinical Operations on the Drug Development Teams (Clinical Strategy Team, Asset Development Teams, and Project Safety Teams)
- Responsible for the development of the clinical strategy and plan for execution of clinical studies/programs (ie generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc)
- Responsible for the development of the costs and timelines for the clinical development programs submitted into the portfolio process
- Responsible for operational decision making, risk mitigation, and contingency planning and operational efficiency and innovation at the program level
- Review and provide clinical operations content to clinical and regulatory documents (IND, IB, NDA, MAA, Regulatory Briefing Books etc)
- Leads cross-functional and within function innovation and process improvement initiatives and ensures effective change management within the organization
- Responsible for developing/managing/mentoring clinical operations staff, including direct supervision of study manager(s), career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
- 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
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.