AbbVie Director, Clinical Pharmacokinetics in Lake County, Illinois
Director, Clinical Pharmacokinetics
USA, Illinois, Lake County
Research & Development
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 knowledge of PK/PD and drug development literature across multiple projects and 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 team. Responsible for mentoring departmental personnel.
Manages personnel, including development, mentoring, and effective delegation. Supervises exempt and/or non-exempt direct reports. Attends regulatory meetings. Identifies and leads efforts designed to support the development of individuals. Anticipates and leads issue resolution. Assures projects remain in alignment with strategic objectives.
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.
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 clinical pharmacology, drug development, and 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.
Level will be based on education and years of experience
PhD in field related to Pharmacokinetics
Team, drug development, and scientific project leadership or related experience.
Advanced project leadership experience of 4-8 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 clinical pharmacology projects.
Demonstrated leadership skills with broad scientific 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.
AbbVie is an Equal Employment Opportunity employer: gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic., At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced