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Program Lead II, Clinical Program Development - job 5 of 6

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 XFacebookInstagramYouTubeLinkedIn 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

*There is potential for the role to be remotely with regular scheduled travel to AbbVie office. 

Additional Information

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 short-term incentive programs. ​

  • 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

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What You Should Know About Program Lead II, Clinical Program Development, AbbVie

If you're ready to take on a pivotal role as the Program Lead II in Clinical Program Development at AbbVie, then get ready for an exciting journey! At AbbVie, we are steadfast in our mission to discover and deliver innovative solutions to tackle significant health challenges today and in the future. As a Program Lead, you'll be the bridge linking operations and science, bringing our clinical studies to life while showcasing your strategic insights. Your day-to-day will be anything but ordinary—developing operational strategies and ensuring that clinical research programs meet the company's objectives with utmost quality and efficiency. Your expertise will directly influence our pipeline assets, guiding teams through the complexities of clinical research with innovative solutions. You’ll have the chance to mentor a talented group, fostering an inclusive environment where we can all thrive. With 12+ years of pharma-related experience under your belt, you understand the intricacies of clinical research and know how to lead global teams toward success. If you’re excited about making a real impact in health care and you meet the qualifications, AbbVie wants to meet you. Come help us create patient-centered solutions that truly transform lives!

Frequently Asked Questions (FAQs) for Program Lead II, Clinical Program Development Role at AbbVie
What are the main responsibilities of a Program Lead II at AbbVie?

As the Program Lead II in Clinical Program Development at AbbVie, your primary responsibilities include developing clinical operational strategies, ensuring the execution of clinical research programs, managing overall portfolio budgets, and mentoring team members. You will translate asset strategies into actionable plans, manage risks associated with clinical programs, and interact with various levels of management to achieve shared objectives.

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What qualifications are required for the Program Lead II position at AbbVie?

To qualify for the Program Lead II role at AbbVie, candidates must hold a Bachelor’s degree in a relevant field or equivalent professional experience. Additionally, a minimum of 12 years of pharma-related experience, with at least 8 years in clinical research and demonstrated leadership within complex clinical studies, is essential. Strong communication skills and a proven ability to mentor and manage teams are also required.

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How does a Program Lead II at AbbVie ensure clinical programs meet company objectives?

A Program Lead II at AbbVie ensures clinical programs meet the company's objectives by developing a detailed clinical operations strategy, closely monitoring progress against budget and timelines, and engaging effectively with cross-functional teams. Your strategic oversight will help identify potential risks and allow for mitigation strategies to keep projects aligned with organizational goals.

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What skills are essential for a successful Program Lead II at AbbVie?

Key skills for success as a Program Lead II at AbbVie include strategic thinking, strong communication abilities, effective stakeholder management, and a deep understanding of global clinical regulations. You should be capable of developing innovative solutions to complex challenges and possess robust mentoring capabilities to guide your team effectively.

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Is remote work an option for the Program Lead II position at AbbVie?

Yes, the Program Lead II position at AbbVie does have the potential for remote work, accompanied by regular travel to AbbVie offices. This flexibility allows for a balanced work-life dynamic while maintaining strong connections with team members and stakeholders.

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Common Interview Questions for Program Lead II, Clinical Program Development
Can you describe your experience leading clinical research studies?

When discussing your experience leading clinical research studies, focus on specific projects where you defined strategies, managed teams, and tackled challenges. Highlight any significant outcomes you achieved and how you navigated the complexities of clinical trials.

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How do you handle risks in clinical programs?

In your response, outline your approach to identifying and evaluating risks in clinical programs. Discuss specific methodologies you’ve implemented to manage risk, such as regular assessments, stakeholder communication, and proactive mitigation strategies.

Join Rise to see the full answer
What strategies do you employ to motivate your team?

Share examples of how you've successfully motivated teams in the past. Discuss your mentoring style, how you create inclusive environments, and any initiatives you’ve led to enhance team morale and productivity.

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Describe a situation where you had to influence senior management.

Provide a concrete example where you influenced senior management's decision-making. Highlight the context, your approach to communication, and how you addressed any resistance, resulting in a successful outcome.

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What methods do you use to ensure compliance with regulations?

Discuss the comprehensive approaches you've used to ensure compliance, such as implementing standard operating procedures, conducting audits, and continuous training for team members to keep updated on regulatory changes.

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How do you balance multiple projects effectively?

Explain your strategy for juggling multiple projects by discussing time management tools, prioritization techniques, and how you maintain clear communication with your teams to ensure milestones are met.

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What is your experience with budget management in clinical trials?

Detail your experiences with budget management in clinical trials. Include examples of how you monitored expenses, made adjustments to stay within budget, and communicated financial constraints to your team.

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How have you improved operational efficiencies in your clinical programs?

Share specific examples of operational improvements you've implemented, detailing the challenges faced, the solutions you developed, and the positive impacts on the clinical trial processes.

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What do you believe is the most challenging aspect of being a Program Lead II?

Discuss the complexities involved in aligning multiple stakeholders, managing diverse teams, and maintaining timelines across various projects. Highlight how you proactively address these challenges through collaboration and strategic planning.

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Why are you interested in working with AbbVie?

Express your admiration for AbbVie’s mission and impact in the healthcare sector. Share how the company’s commitment to innovation aligns with your professional goals and values, highlighting your eagerness to contribute to their vision.

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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: i...

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Full-time, hybrid
DATE POSTED
April 22, 2025

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