Program Lead II, Clinical Program Development

AbbVie Inc.; North Chicago (IL); On-site; USD 180,000 - 250,000; Full time

Job summary

AbbVie Inc. is seeking a Clinical Operations Program Director to connect science and operations, driving execution of clinical research programs with strategic asset leadership and operational excellence.

This role also develops a pipeline of talent and guides study managers across global teams. You will influence senior leaders, ensure quality, and manage budgets while fostering an inclusive, innovative environment in a fast-paced development organization.

Qualifications

• Bachelor’s degree or equivalent in nursing or scientific field; an Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
• 12+ years of Pharma-related/clinical research experience (and/or applicable work experience)
• 8 years in clinical research demonstrating leadership competencies and strategic impact
• Proven ability to lead a global team in managing multiple, complex clinical studies
• Coaching/mentoring and people management experience; remote management preferred
• Experience initiating through study completion (Phase 1-3, 4) and data analysis
• Expertise in SOPs, ICH, Global Regulations, Ethics and Compliance
• Strong communication and stakeholder management skills

Responsibilities

• Develop clinical operational strategy and ensure programs are executed on time, within budget and meeting objectives
• Translate asset strategy into operational execution by linking science with business, operations, patients and customers
• Identify and mitigate risks at program level to achieve asset strategy
• Interact with senior leadership and cross-functional teams to achieve program objectives
• Review clinical operations content for clinical and regulatory documents
• Manage external budgets across portfolio (programs often $20–$200M)
• Mentor and develop study managers; foster inclusive, innovative environment
• Execute clinical programs in compliance with ICH/GCP, regulations and AbbVie policies
• Communicate effectively with stakeholders and drive activities to deliver programs
• Sustain staff development and talent growth within Development Operations

Skills

Pharma/clinical research experience

Global team leadership

People management

Communication skills

Education

Bachelor’s degree in nursing or science

Associate’s degree/R.N. acceptable

Job description

About AbbVie

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.

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

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.

Responsibilities

• 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)

Qualifications

• 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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html