Program Lead II, Clinical Program Development (Director Level)

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 :

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 Companys 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. 

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No

Employment Type :

Full-time