- Provides expert scientific and strategic consultation to R&D, Regulatory Affairs, Regulatory Agencies, and all levels of management on critical decisions and development plans for multiple projects across multiple therapeutic areas. Leads development of modeling and simulation.
- Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Complies with procedures set forth in: Departmental Guidelines, Relevant IQS documents, Study protocols and other directives issued by the management regarding clinical/ preclinical studies.
- Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software. Maintains through and in-depth knowledge of PK/PD and drug development literature across multiple therapeutic areas.
- Provides leadership and develops strategic Drug Development recommendations to therapeutic areas. Leads teams within department, across CPPM and across functions. Responsible for leadership of cross-functional teams. Responsible for mentoring departmental personnel. Attends regulatory meetings
- Manages personnel, including development, mentoring, and effective delegation. Supervises exempt and/or non-exempt direct reports. Identifies and leads efforts designed to support the development of individuals.
- Independently leads PK/PD activities and multiple self-initiated major projects. Assists R&D senior management in the selection of action plans that best meets clinical pharmacology and drug development business objectives.
- Anticipates and leads issue resolution. Assures alignment of multiple projects with strategic objectives. Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance).
- Responsible for leading efforts to develop departmental goals. Makes strategic PK/PD decisions for the department and division. Provides leadership to the department on strategic drug development business issues.
- Establishes and manages tools & processes needed to ensure employee proficiency with departmental systems, procedures, tools and guidelines (e.g., training, mentoring, and effective delegation). Responsible for overseeing operations activities/ projects managed by others within department. Responsible for short- and long-term plans and management of implications of alternative scenarios.
- Actively manages project team behaviors, mediates team disputes, and facilitates establishment of healthy and high performing teams. Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship. Conducts risk assessments and leads the function in development of contingency plans.
- PhD with 9+ years of experience or Pharm D with 11+ years of experience in a relevant field*; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Team, drug development, and scientific project leadership or related experience.
- Advanced project leadership experience of 9 + years related to clinical research, drug development and department operations. Proven record of successful projects.
- Recognized as an expert with global knowledge of AbbVie and Pharma drug development processes
- Recognized leader in complex scientific analyses, business-related procedures, and leadership of multiple projects.
- Demonstrated leadership skills with broad scientific, strategic and business-related orientations.
- Requires multi-faceted, broad-based experience in multiple functions. Considered to have in depth knowledge of drug development issues and business needs.
Significant Work Activities: N/A
Travel: Yes, 10 % of the Time
Job Type: Experienced