Program Lead II, Clinical Program Development

Allergan; Irvine (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Clinical Operations Program Director to connect science and operations, leading one or more clinical research programs and serving as a strategic advocate for pipeline assets.

The role requires developing a team, managing execution of complex studies, and partnering with Development Operations and Global Medical Affairs to ensure compliant, efficient program delivery.

Qualifications

• Bachelor’s degree in nursing or scientific field; an Associate’s degree/R.N. with relevant experience acceptable.
• 12+ years pharma/clinical research experience.
• 10+ years leading global clinical studies and cross-functional teams.
• Experience in risk management, decision-making, and strategic execution.
• Strong communication and mentoring skills; remote management preferred.
• Subject matter expert in ICH, Global Regulations, Ethics and Compliance.

Responsibilities

• Integral member of the Pipeline Commercialization Model’s Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee whose remit is to maximize value of assets and portfolio for patients and AbbVie.
• Develops clinical operational strategy aligned with asset strategy and oversees execution of clinical studies/programs (timelines, enrollment options, patient population availability, trial design complexity vs speed).
• Evaluate risks and mitigations to asset strategy and identify strategic options for the Asset Strategy Team.
• Interacts with and influences all levels of management and cross-functional teams to achieve program objectives across Development Operations and Global Medical Affairs Therapeutic Area MDs/SDs.
• Contributes to portfolio planning including costs, resource projections and timelines for development programs.
• Reviews and provides clinical operations content to regulatory documents (INDs, IB, NDAs, BLAs, MAAs).
• Manages external budget across portfolio (20–200 million dollars).
• Leads cross-functional innovation and process improvement initiatives with large business impact and drives change management.
• Mentors and develops clinical operations staff; supports growth into leadership roles (4–15 study managers, up to 30 indirect staff).
• Ensures program execution adheres to ICH/GCP and global regulations.

Skills

Leadership

Strategic thinking

Stakeholder management

Global program management

Risk management

Coaching/mentoring

Communication

Education

Bachelor’s degree in a scientific field

Associate degree/R.N. acceptable with relevant experience

Job description

Company 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 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 Model’s 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 asset’s 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

• 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)
• 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

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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

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https://www.abbvie.com/join-us/reasonable-accommodations.html