Program Lead

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.

In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities:

• Aligns Data Science and Statistics study teams with program- and study-level strategies. Supports governance of assigned programs and studies, both within and outside Data Science and Statistics. Assigned programs may include programs of any size or any complexity
• For assigned programs, acts as single point of contact and accountable operational lead from Data Science and Statistics. Coordinates associated Data Science and Statistics study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at both the program and study levels
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives. Represents Data Sciences in cross-functional forums and, if assigned, leadership meetings
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines of own, as well as studies managed by the team. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. Coordinates and participates as the Data Sciences study owner in regulatory inspections and internal quality audits
• Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
• Responsible for coaching and mentoring team members, as well as providing input into their development
• Leads Data Science and Statistics and cross-functional innovation and process improvement initiatives
• If assigned, responsible for identifying training needs and standardizing and facilitating training solutions for Data Sciences roles. Conducts “lessons learned” across functions
• May include direct and/or indirect supervision of staff, as well as contract resources

Requirements

*This position can be hired at the Program Lead I, II, or III level depending on years of experience and education*

Qualifications for PL III:

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired.
• Must have 8+ years of pharma / clinical research / data management / health care experience or 10+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and involved functional stakeholders, and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is required.

Qualifications for PL II:

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired.
• Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred

Qualifications for PL I:

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired
• Must have at 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience)
• Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred