AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Job Function
Executes clinical PK/PD research or development that achieves project and therapeutic area goals. Understands PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and assists with responses and appropriate new strategies.
Demonstrates PK/PD excellence, work ethic, and dedication to team/project goals.
Effectively presents data and technical information.
Investigates, identifies, develops, and optimizes new PK/PD models. Acts as a lead Pharmacokineticist on one or more studies. Critically evaluates relevant PK/PD and regulatory advances, and integrates this knowledge into development programs when applicable.
May contribute to due diligence.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Utilizes PK/PD expertise to provide PK/PD consultation to GPRD and management on decisions and development plans, for multiple projects within a therapeutic area.
Develops productive collaborations and communications with functional and technical experts across multiple disciplines to facilitate PK/PD achievement. Writes and communicates PK/PD materials.
Communicates/presents key PK/PD information to senior management. Serves as liaison to other departments for multiple studies.
Assists in the development of commercial and regulatory strategies by formulating PK/PD plans including development activities
Contributes to the development of PK/PD plans to satisfy regulatory expectations and defends plans and interpretation of data to GPRD management.
Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact).
May contribute to due diligence.
Contributes to PK/PD interpretations of reports for regulatory filings and clinical protocols.
Primary contributor to interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions. Author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings.
Uses external information to gain competitive intelligence. Act as advocate for integrating this knowledge into the project team’s research efforts.
Position Accountability / Scope
Receives assignments from Director/ Associate Director/Assistant Director and is responsible for completing tasks on schedule with minimal supervision.
Reviews key decisions impacting PK/PD timelines with department management.
May attend project team meetings and reviews key scientific decisions impacting project timelines with department management.
Demonstrates a high degree of responsibility in maintaining PK/PD standards, GxP compliance, and safe operating practices for self.
Participates in establishing project goals, defining short and long-term PK/PD strategies, and contributes to the generation of project-related documents and presentations.
Keeps accurate and current records of project related activities according to Abbott policies.
Minimum Education
PhD in field related to Pharmacokinetics.
1-3 yrs experience.
Demonstrates technical expertise on PK/PD projects.
Must have demonstrated ability to lead PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion.
Knowledge of standard business procedures (regulatory guidances, global regulations, SOPs).
Minimum Experience / Training Required
Identifies technical issues impacting project and elevates to management for resolution.
Participates in process improvement initiatives.