Program Lead II, Clinical Program Development

BioSpace; Branchburg Township (NJ); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Clinical Operations Program Director to connect science and operations, guiding clinical studies from inception to completion. You will lead a global team, drive strategic execution, manage budgets and timelines, and ensure regulatory and quality compliance across assets and programs.

You will mentor staff, collaborate with cross-functional partners, and advocate for pipeline assets while delivering innovative solutions to complex trials in a fast-paced environment.

Qualifications

• Bachelor's degree or equivalent required in nursing or scientific field; Associates degree/R.N. acceptable with relevant experience.
• 12+ years of Pharma-related/clinical research experience or applicable work experience.
• 10 years in clinical research with leadership of global teams and multiple studies.
• Experience in risk management, strategic execution and decision-making.
• Strong communication and coaching/mentoring skills; remote management preferred.
• Subject matter expert in ICH, Global Regulations, Ethics and Compliance.
• Experience in study initiation through completion (Phase I–III, IV).

Responsibilities

• Develop clinical operational strategy aligned with asset strategy and oversee execution of clinical studies/programs.
• Lead cross-functional teams across Development Operations and Regulatory to maximize asset value.
• Evaluate risks and mitigations; identify strategic options for asset strategy team.
• Manage budgets, costs, resources, and timelines for development programs.
• Contribute to study documentation, INDs, IBs, NDAs, BLAs, MAAs and regulatory briefing books.
• Mentor and develop clinical operations staff, including remote management.
• Ensure compliance with quality standards (ICH/GCP, Global Regulations).

Skills

Strategic leadership

Global mindset

Risk management

Program execution

Executive communication

Coaching/mentoring

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree or equivalent in nursing or scientific field

Associates degree/R.N. acceptable with relevant experience

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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

• Integral member of the Pipeline Commercialization Models Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee whose remit is to maximize the value of our assets and portfolio for patients and AbbVie.
• In alignment with the assets strategy and incorporating the science and the operations, develops the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed)
• Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy. Identifies strategic options for the Asset Strategy Team to evaluate 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: primary scope of influence is within Development Operations, cross-functional colleagues who support clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs.
• Key contributor to the portfolio planning process including responsibility for the development of the costs, resource projections and timelines for the clinical development programs under consideration.
• Reviews and provides clinical operations content to clinical and regulatory documents (e.g., 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 across the cross-functional areas that support clinical program execution.
• Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 15 study manager(s) and up to 30 indirect staff, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed
• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)

Qualifications

• Bachelors degree or equivalent is required, typically in nursing or scientific field. An Associates 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)
• 10 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
• Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.
• Possesses good communication skills.
• Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).
• Considered a subject matter expert in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
• Integral participation in initiatives or advancement of strategies for clinical operations.
• Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase l-3, 4).

Additional Information

• 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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys 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